21 June 2014

Implantables and Wearables

'Digital Medicine, the FDA, and the First Amendment' (MSU Legal Studies Research Paper No. 12-08) by Adam Candeub comments 
Digital medicine will transform healthcare more fundamentally than the introduction of anesthesia or the discovery of the germ basis of infectious disease. Inexpensive computerized DNA sequencers will allow practitioners to individualize drugs and treatments. Digitalization will "democratize medicine," enabling individuals to create and use their own medical data, even diagnose or treat themselves. Already, tens of thousands of "medical apps" are available for smartphones that can do everything from take echocardiograms, blood pressure, pulse, lung function, oxygenation level, sugar level, breathing rate and body temperature to diagnose skin cancer and analyze urine. Medical apps, aimed at practitioners but available all, such as Isabel, diagnose diseases.
In fall 2013, the Federal Drug Administration (FDA) has asserted regulatory authority over mobile medical applications and other digital medical services, threatening, to chill, if not, destroy this innovation — and guaranteeing lengthy, high profile litigation in the near future. This article argues that the FDA stands on firm legal ground regulating medical devices that invasively measure bodily functions or take physical specimens. On the other hand, the FDA’s exercise of jurisdiction over applications that simply process information, such as Isabel, or use approved medical devices to provide medical information, like 23andMe, a genome analysis firm which the FDA recently shut down in a high profile action, raise legal concerns. Because these medical applications simply process information, they stand beyond the FDA’s regulatory reach under the Food, Drug and Cosmetics Act and the Administrative Procedure Act.
This paper adds to the large debate on the First Amendment, information and computer code. Building on recent Supreme Court decisions, this paper shows how code and applications which create healthcare information are protected speech. Given digital applications’ capacity to produce pools of data which researchers can mine for clinical and epidemiological insights and given government funding of medical services, healthcare data is both scientific and political speech, deserving of full First Amendment protection.
'Cleaning House: The Impact of Information Technology Monitoring on Employee Theft and Productivity' [PDF] by Lamar Pierce, Daniel Snow and Andrew McAfee considers
how investments in technology-based employee monitoring impact both misconduct and productivity. We use unique and detailed theft and sales data from 392 restaurant locations from five different firms that adopt a theft monitoring information technology (IT) product. Since the specific timing of individual locations’ technology adoption is plausibly exogenous, we can use difference-in-differences models to estimate the treatment effect of IT monitoring on theft and productivity within each location for all employees. We find significant treatment effects in reduced theft and improved productivity that appear to be driven by changing the behavior of individual workers rather than selection effects. Although workers with past patterns of theft appear more likely to leave treated locations than others, individual behavioral changes by existing workers drive restaurant-level improvements. These findings suggest multi-tasking by employees under a pay-for-performance system, as they increase effort toward sales following monitoring implementation in order to compensate for lost theft income. This suggests that employee misconduct is primarily a result of managerial policies rather than individual differences in ethics or morality.
The authors comment
Employee theft and fraud are widespread problems in firms, with workers stealing roughly $200 billion in revenue from U.S. firms to supplement their income (Murphy 1993). A growing empirical literature on forensic economics has clarified when and how theft and other misconduct occur (e.g., Jacob and Levitt 2003; Fisman and Wei 2009; Zitzewitz 2012a), but says little about the overall impact of firms’ use of forensics to monitor and reduce theft. This is a critical shortfall in the literature, given the substantial investments made by firms in monitoring employees (Dickens et al. 1989), as well as the growing forensic and monitoring capabilities enabled by information technology (IT) systems. This raises two important yet unanswered questions about the economic impact of monitoring employee crime. First, if monitoring is indeed effective in reducing theft, as theory (Becker 1968; Dickens et al. 1989) and some evidence (Nagin et al. 2002) suggests, do these gains primarily result from changing worker behavior or instead from replacing less honest workers with more honest ones? Second, if increased monitoring reduces theft of existing workers, how do they adjust effort on other tasks in response to this lost income, and what is the overall impact on firm productivity? Recent research on corruption suggests that reducing one type of misconduct through monitoring might invoke a multitasking response that increases other corrupt activities that substitute for lost income (Olken 2007; Yang 2008).
In this paper we address these questions by examining the impact of improved theft monitoring from information technology in the American casual dining sector, using a unique dataset that details employee-level theft and sales transactions at 392 restaurants in 38 American states. We focus on this setting for several reasons. First, detailed theft and sales data allow us to identify specific worker-level productivity, theft, and sorting responses to changes in firm monitoring. Second, unlike previous research on monitoring (e.g. Duflo et al. 2012; Zitzewitz 2012b), restaurants provide a firm-based setting where workers receive commission-based pay-for-performance compensation that incentivizes substitution from the monitored task (theft) to the unmonitored and productive one (sales). Third, the increased monitoring in our setting results from the staggered implementation of improved IT monitoring systems across multiple locations. Although the impact of IT on productivity increases in firms is well documented (David 1992; Brynjolfsson 1993; Grilliches 1994; Nordhaus 2001; Bharadwaj 2000; Bresnahan et al 2002), no research examines potential productivity gains through reduced theft or other misconduct. Recent work by Bloom, Sadun, and Van Reenen (2012) shows that the productivity gains from IT have been most substantial in industries, such as restaurants, that have “tougher” human resource practices with higher-powered incentives.
We conceptualize the employee theft issue as a stylized multitasking problem (e.g., Holmstrom and Milgrom 1991), where workers under a pay-for-performance scheme (such as tips) can derive earnings from two tasks: sales productivity and theft. Earnings from each task are increasing and concave in effort. The cost of effort from each task is convex and increasing, but theft bears two additional costs. First, the employee will be detected and punished by management (the principal) with some probability p that is increasing in theft. Second, the employee may suffer moral or ethical costs based on identity or preferences that make theft costly even when it is effortless and unmonitored (e.g. Akerlof and Dickens 1982; Mazar et al. 2009; Bénabou and Tirole 2011; Dal Bó and Terviö 2013).
Such a setup has three immediate implications for the impact of increased IT monitoring on employee effort allocation. First, any employee with existing non-zero theft levels will reduce effort allocated to theft in response to increased monitoring by management. Second, the resulting decrease in earnings will thus motivate them to increase effort allocated toward productivity. Third, employees with existing non-zero theft levels will be more likely to leave the firm as outside employment options become relatively more attractive than before.
We use approximately two years of detailed theft and sales data from 392 restaurant locations from five restaurant firms (hereafter referred to as “chains”) that adopt an IT monitoring product, NCR Corporation’s Restaurant Guard, that reveals theft by specific employees. Restaurant servers (also called waiters) use multiple techniques to steal from their employers and customers, including voiding and “comping” sales after pocketing cash payment from customers, and transferring food items from customers’ bills after they have paid. Restaurant Guard alerts managers to egregious examples of these actions in a weekly report. These alerts represent the “tip of the theft iceberg”, since the product is designed to identify instances of theft that are so obvious as to be indefensible by servers. Consequently, while the weekly alerts in our data average only $108 per location, interviews with managers indicate the losses to be considerably larger.
Our data provide the identity of each server, as well as the revenue, theft alerts, tips, shifts, and food items sold for each day. The data also provide the date on which Restaurant Guard was implemented at each location. The Restaurant Guard product was rolled out to individual store locations in a plausibly piecemeal way not related to individual store needs or theft levels. Rather, the rollout pattern was driven by the schedule and week-to-week geographic location of the vendor’s Restaurant Guard implementation team. This rollout strategy allows us to treat adoption dates as plausibly exogenous to the individual restaurant location and not correlated with revenue or theft levels. Our quasi-experimental setting thus enables us to estimate behavioral and productivity changes within each location across all employees. We use difference-in-differences models to estimate the treatment effect of the monitoring technology on theft, sales productivity, employee turnover, and other performance metrics at both the individual and restaurant level. The different implementation dates for each location allow us to control for time trends and time-invariant location-specific and worker-specific fixed effects.
Our empirical models identify a 22% (or $24/week) decrease in identifiable theft after the implementation of IT monitoring. This treatment effect is persistent, with the magnitude growing from $7 in the first month to $48 in the third month. The treatment effect on total revenue, however, is much larger. Total revenue increases by $2,975/week (about 7% for the average location) following implementation of Restaurant Guard, suggesting either a considerable increase in employee productivity or a much larger latent theft being eliminated by the IT product. Furthermore, the implementation of Restaurant Guard increases drink sales (the primary source of theft) by $927/week (about 10.5%). This result is particularly important because the profit margins on drinks in casual dining are between 60 and 90 percent, representing approximately half of all restaurant profits. Furthermore, we observe an increase in average tip levels of 0.3%, which represents one sixth of a standard deviation improvement from a base rate of 14.8%. This result suggests improvement in customer service from IT monitoring.
While these results show considerable impact on theft, revenue, and profitability for the restaurants, they do not explain the mechanisms through which these improvements are gained. To disentangle these mechanisms, we examine the impact of the IT product on individual employee outcomes. We employ a similar difference-in-differences approach, alternatively including worker and restaurant fixed effects to examine whether our results are due to behavioral changes in existing workers or selection effects as the worst workers leave the restaurants (e.g. Lazear 2000; Hamilton et al. 2003).
These individual worker models show that Restaurant Guard reduces average hourly theft by between $0.05 and $0.06 in both models. This suggests that all the decrease in theft found in our restaurant-level models can be explained by employees changing their behavior, as opposed to a change in the group of employees working at the restaurant. We also find that IT monitoring also increases hourly sales by $2.02 for existing workers, with similar increases for drink sales and tip percentage. In each case, the worker fixed models suggest behavioral changes by workers rather than a selection effect. Given the pay-for-performance compensation policy of our restaurants, these results are consistent with multi-tasking and principal-agent models of worker behavior (Alchian and Demsetz 1972; Holmstrom and Milgrom 1991). When a worker’s ability to gain money from theft is reduced due to increased monitoring, he or she reallocates effort toward increasing sales and customer service in order to regain some of that loss.
Finally, our models shed light both on how management responds to the new theft information and on workers’ endogenous choices to leave the firm. To do so, we separate workers into “known thieves” and “unknown” groups based on their observed (by the researchers, not by the managers) pre-treatment theft. Known thieves are those with observable pre-treatment theft. Cox hazard models show employees with known pre-treatment theft levels have higher attrition rates than do employees without observable theft. The observation that these exits are unlikely to happen within two weeks of a theft report to management suggests that this attrition is voluntary and not due to termination following theft revelation to management. This voluntary attrition by thieves following increased monitoring is consistent with workers selecting out of jobs after monitoring limits theft income. The apparent rarity of termination also echoes Dickens et al.’s (1989) observation that firms infrequently employ the efficient low-monitoring, high-punishment crime deterrence strategy described in Becker (1968). We also observe that while known thieves’ weekly hours remain unchanged following the IT implementation, other workers’ weekly hours increase on average by 2.25 hours, which is consistent managers reallocating the hours toward more honest workers.
This paper has implications for several important research streams. First, we contribute to the literatures on forensic economics and corruption. Only a few studies focus on explicitly illegal behavior by employees of private firms, and those that do almost exclusively rely on empirical evidence aggregated at the firm level (Fisman and Wei 2004; 2009; Zitzewitz 2006; Heron and Lie 2007; DellaVigna and La Ferrara 2010; Chen and Sandino 2012; Pierce and Snyder 2012).8 Our worker-level data, like Nagin et al.’s (2002) study of call center fraud, allow us to disentangle firm-level misconduct from individual-level decisions that run counter to firm profitability. Unlike their work, however, our multi-firm longitudinal data allow us to more comprehensively examine the impact of monitoring on selection and treatment across multiple tasks, including productivity. Our results show that employee productivity and misconduct are linked through organizational policies such as compensation or information technology monitoring. This unique finding is particularly important because it has roots in foundational models of compensation that allow for both productivity and sabotage (Lazear 1989).
Our results also contribute to work in personnel and organizational economics on employee response to compensation systems. While theory modeling counterproductive employee behavior is extensive (Alchian and Demsetz; Jensen and Meckling 1976; Holmstrom 1979; Lazear and Rosen 1981; Holmstrom and Milgrom 1991), only recently has empirical work examined incentives impact explicitly illegal behavior in firms. A growing literature on bonus gaming examines employees’ strategic responses to incentive systems (e.g. Oyer 1998), but these behaviors are not clearly corrupt or illegal. The fundamental difference between counter-productive and explicitly illegal behaviors goes beyond standard principal-agent and multi-tasking models because effort allocated toward illegal behaviors not only indirectly hurts the firm through foregone production, but also directly hurts the firm through such costs as stolen revenue and legal liability. Furthermore, our study suggests that the effort that workers allocate toward corrupt or illegal behavior can be redirected toward more productive behavior through incentives. Interventions can simultaneously reduce theft and improve productivity, a result that to the best of our knowledge has not been observed in the field.
Finally, we contribute to the literature showing the impact of technology on productivity (Brynjolfsson 1993; Brynjolfsson and Hitt 1996; David 1992; Griliches 1994; Athey and Stern 2000; Nordhaus 2001). One of the key findings from this research has been the impact of IT on labor productivity growth (Jorgenson and Stiroh 2000; Oliner and Sichel 2000). While other studies show that IT can also improve productivity by reducing mild forms of misconduct such as shirking and absenteeism (Hubbard 2000; Baker and Hubbard 2003; Duflo et al. 2012), our paper is the first to show both the direct impact in reducing explicitly illegal behavior such as theft as well as the secondary effect of incentivizing increased productivity. Furthermore, our paper supports the view that the impact of IT systems is intimately tied to other elements of firm policy such as asset ownership (Baker and Hubbard 2003; Rawley and Simcoe 2013), human resource policy (Bloom et al. 2012), and other organizational practices such as products and services (Bresnahan et al. 2002). The impact of IT monitoring on sales and customer service increases in our setting is likely dependent on the tip-based compensation system that incentivizes wait staff to increase productivity after theft is constrained by monitoring.

Medical research fraud and vetting

What happens when the watchdogs are asleep or complicit in serious misbehaviour? What does it take to live-down past stigma?

The UK Independent tartly reports that consultant surgeon Anjan Kumar Banerjee, who was appointed an MBE in last week's Queen's Birthday Honours for services to patient safety, is "a serial fraudster who has harmed patients and was struck off the medical register in 2002 for gross professional misconduct".
It appears the Cabinet Office Honours Committee, which selects candidates for the awards, was unaware of Dr Banerjee's background. In 2000 he was involved in one of the most notorious cases of research misconduct in recent medical history. He was found guilty of falsifying a scientific paper which had been published in 1990 but was covered up for a decade.
He was awarded a degree by the University of London and made a professor by the Royal College of Surgeons based on the fraudulent research. He was later suspended from the medical register and his co-author, Professor Tim Peters, was also found guilty of serious professional misconduct for his part in the cover up.
Two years later Dr Banerjee was again found guilty of serious professional misconduct for financial dishonesty and was struck off the medical register. He had misled patients about the length of NHS waiting lists to induce them to go private and had sought payment for treatments not performed. Concerns were also expressed about his clinical skills.
He was restored to the register in 2007. Under General Medical Council rules, doctors who are struck off may apply for re-instatement after five years. He now uses the name Swapu Banerjee and specialises in drug safety and clinical risk management as head of development consulting at Pope Woodhead, as well as operating part time at Bedford hospital.
Peter Wilmshurst, a cardiologist at the University Hospital of North Staffordshire and a campaigner on medical research fraud, said: "Mr Banerjee did awful things and only eight years after getting back on to the medical register he is rewarded with an MBE".
"If you have got a record of misconduct going back to the late 1980s, you would have to do something very remarkable in the next eight years to deserve an award. But I have not heard of him doing anything."
A spokesman for the Cabinet Office said: "We are currently looking into the MBE awarded to Dr Banerjee. Like any other nomination, it will have been considered on merit based on the information provided to the relevant independent committee, in this case the Health Committee."
A spokesman for Bedford Hospital said: "All necessary employment checks were carried out by the trust when he was appointed."
'Consultant suspended for research fraud' by Annabel Ferriman in (2000) 321(7274) BMJ 1429 adds some context, stating -
A consultant surgeon in England was found guilty of serious professional misconduct last week for publishing fraudulent research results.
Mr Anjan Kumar Banerjee, aged 41, of the Royal Halifax Infirmary, was suspended for a year by the General Medical Council for publishing an article in Gut in December 1990 that contained information which "was deliberately falsified".
"The outcome was that a wholly misleading article went into circulation", said Mr Rodney Yates, chairman of the professional conduct committee.
In addition to publishing a fraudulent article in Gut — a charge which the surgeon had denied — Mr Banerjee admitted that in 1990 he submitted an abstract to the British Society of Gastroenterology, the contents of which had been falsified. He claimed the results were based on urine samples from "12 healthy adults" whereas the samples were in fact of his own urine.
Mr Yates said: "Medical research is central to the advance of medical practice and must always be conducted with scrupulous honesty and integrity. It is highly irresponsible, and potentially dangerous for patients, for a doctor to falsify research."
"The committee consider that these events illustrate seriously irresponsible and dishonest behaviour on your part."
Mr Banerjee, who is at present suspended from his job in Halifax for reasons unconnected to the case, was a junior doctor at King's College Hospital, London, at the time that the offences took place.
He was reported to the GMC by consultant cardiologist Dr Peter Wilmshurst of the Royal Shrewsbury Hospital, who has campaigned over many years on issues of research fraud.
Dr Wilmshurst said this week: "Although it has taken three years for the GMC to investigate and find Mr Banerjee guilty, the real problem is the six to seven years that it took for the case to get to the GMC, despite the fact that it was well known at King's. The delay was due to the pressure brought to bear on the whistleblowers to keep silent".
The investigation by the GMC was made particularly difficult because the authorities at King's had selectively shredded the laboratory books that had been in existence when Mr Banerjee was carrying out his research, something which was admitted at the hearing.
We need to consider whether the medical school and the University of London behaved properly in this matter. It is clear that senior doctors and administrators were aware of the problems in the early ‘90s but took inadequate action to draw them to the attention of the proper authorities.
London University gave Mr Banerjee a Master of Surgery degree, when there are documents existing which show that they were told that the research in his thesis was fraudulent.”
In 2002 the BBC reported
A consultant surgeon who persuaded patients to opt for private treatment so he could make more money has been struck off for serious professional misconduct.
A General Medical Council (GMC) hearing in Manchester was told Dr Anjan Kumar Banerjee lied to patients about NHS waiting times for surgery.
He told them it would be quicker to go private - and then made money by providing the treatment himself.
Elizabeth Walker, chairman of the GMC committee which heard the case, said: "Your actions were motivated by financial gain and your evidence to the committee demonstrated that you continue to have little or no insight into the seriousness of your actions."
Dr Banerjee had twice as many paying patients as other consultant general surgeons, the GMC was told.
The surgeon, who worked for Calderdale and Huddersfield NHS Trust as well as the Bupa Hospital in Elland, West Yorkshire, pocketed money for carrying out operations on patients he had advised to go private between January 1997 and March 2000.
Timothy Brennan, counsel for the GMC, said: "This consultant was motivated by a zeal to charge for certain procedures in order to line his own pockets."
Dr Banerjee also claimed rates of payments for procedures which were different to the rate for the operations actually carried out.
"One such payment was misleading, dishonest and undertaken for financial gain," added Mr Brennan.
The sobering 'Institutional Corruption In Medicine' by Peter Wilmshurst in (2002) 325(7374) BMJ 1232 comments that
A decade elapsed between Anjan Kumar Banerjee admitting to senior doctors at King's College Hospital that he had falsified scientific research and the finding by the Professional Conduct Committee of the General Medical Council on 30 November 2000 that Banerjee was guilty of serious professional conduct because of that dishonesty. Professor Timothy John Peters, Banerjee's research supervisor from 1988 to 1991, was also found guilty of serious professional misconduct at a separate hearing on 28 February 2001. The GMC found that, after he became aware that Banerjee had falsified research, Peters had failed to prevent Banerjee falsifying further research, failed to retract publications that contained falsified research and which named both of them as authors, failed to bring Banerjee's misconduct to the attention of the GMC, and supplied a misleading final report on Banerjee's work to the Medical Research Council, which had funded the work.
This much is well reported, but the greater scandal is less well known. This was not just a case of one doctor covering up for another, but of corruption at a senior level in academic institutions that have special roles in the appointment of non-elected members to the GMC. The failure to deal with Banerjee's fraudulent research at an early stage in his career allowed him to gain a consultant post despite concerns about both his honesty and his clinical competence. By November 2000, when the GMC suspended Banerjee from the Medical Register for one year because he had falsified his research, he had been suspended from his consultant post for eight months because of concerns about financial probity and clinical competence. At his second hearing before the Professional Conduct Committee in September 2002, Banerjee was erased from the Medical Register because of serious professional misconduct resulting from his financial dishonesty and inadequate clinical care.
Wilmshurst offers a cogent and detailed analysis,  commenting
In 1988, soon after he started his research with Peters, doubts were expressed about Banerjee's honesty. Banerjee wrote two draft papers on the effects of non-steroidal anti-inflammatory drugs on the bowel of rats. He included four other workers from the hospital on the drafts. In addition to Peters, they were Dr (now Professor) Ingvar Bjarnason, Dr Paul Smethurst, and Dr (now Professor) Ashley Price. These workers expressed concerns to Peters. Bjarnason and Smethurst stated that they had no involvement with the studies and that they were unable to find evidence that Banerjee had done the large amount of animal work described in the papers in his spare time. Indeed, they could find no evidence that Banerjee had access to some of the equipment described in the draft papers or had been trained to use it Price stated that the few histology specimens shown to him did not justify the radical claims made. The three refused to have their names associated with the research. Shortly afterwards, Peters took up a professorship at King's College Hospital. Many of the staff who had worked with him at Northwick Park also moved to King's. Banerjee took up a MRC training fellowship, with Peters as his supervisor, in March 1989. His research on the effects of non-steroidal anti inflammatory drugs on the bowel was also awarded research grants by two charities and a pharmaceutical company. Bjarnason followed later. Before Bjarnason arrived, other researchers at King's (Dr Roy Sherwood, Dr Kishore Raja, and Dr Robert Simpson) and a collaborator at St Thomas's Hospital (Dr Ian Menzies) reported concerns to Peters that Banerjee had falsified research in human studies. Sherwood noted that the amount of radioactive isotope Banerjee had claimed to have used was considerably more than that ordered for the whole department. ....
Meanwhile, the two draft papers on non-steroidal anti-inflammatory drug enteropathy, from which three coauthors had asked that their names be removed,) were combined into one paper and submitted to Gut as a full paper, with Banerjee and Peters as the only authors. Ten years later, in November 2000, the GMC found that the research in this paper was also falsified. In 1990 other work by Banerjee came under suspicion, and King's College Hospital started an inquiry into Banerjee's research. At the end of that inquiry in July 1991, Professor Harold Baum (head of the School of Life, Basic Medical, and Health Sciences) wrote a confidential letter to Peters with a copy to Mr H T Musselwhite (secretary to the Medical School) stating: "Having carefully examined the documentary evidence which you sent me, I am totally satisfied that much of the research data reported by Dr Banerjee since 1988 is at best unreliable, and in many cases spurious."
That documentary evidence, including Banerjee's laboratory books, was never seen again. It absence impeded the GMC's investigation of Banerjee. King's College did not inform the Medical Research Council or other grant awarding organisations that the research that Banerjee had claimed to have performed with their grants was apparently falsified, and none of those grants was repaid. Peters was criticised by the GMC for failing to document the concerns about Banerjee in his final report to the MRC. Meanwhile, Banerjee had submitted a thesis to the University of London for a master of surgery degree based on the research published in Gut. We now know that this research was falsified. Because he was unable to get an assurance from the authorities at King's College that they would notify the University of London that Banerjee's thesis (for which he was awarded a master of surgery degree) was based on suspect research, Bjarnason notified the university directly. On 7 August 1991 Bjarnason wrote to the Senate and Academic Council Secretariat of the University of London. He reiterated concerns that he had previously expressed to the university that the research in Banerjee's thesis was falsified and that six coworkers had expressed similar concerns. However, he stated that he has been advised to drop the matter by Professor Peters or his career would suffer and accordingly he was retracting his allegations under duress. The university acknowledged receipt of the letter.Many people might consider a retraction made by a person who claims to be under duress is not a genuine retraction.
The university seems to have taken no further action, until prompted by me on 5 December 2000 to look again at Banerjee's thesis after his GMC hearing. The academic registrar of the university wrote to me on 21 December to ask whether I could provide them with copies of the university's documents, since they could not find their own copies. I did so. Despite repeated requests from me, the university has still not informed me whether it will withdraw the degree awarded as a result of fraud. ....
Banerjee left King's College and moved through other training posts to be appointed as a consultant surgeon in Halifax. New concerns quickly arose, and eight months before his hearing by the GMC Banerjee was suspended by his hospital because of allegations entirely unrelated to the research fraud at King's. The Royal College of Surgeons was asked to investigate Banerjee's clinical competence, and an independent authority was asked to investigate his honesty. While this was happening, Banerjee was nominated for fellowship of two of the three royal colleges of physicians in the United Kingdom. One nomination was successful. The other failed. This was not because of any official check, but because I chanced to see Banerjee's name on the nomination list and informed the college that his appearance before the GMC was imminent There seems to be a communication problem if two medical royal colleges were considering honouring a surgeon by awarding him a fellowship without being aware that he was facing a hearing before the GMC and was under investigation by the Royal College of Surgeons, his employer, and other bodies.
Banerjee resigned from his hospital after the GMC suspended him from the Medical Register for one year. During his suspension, I asked the GMC to speedily investigate the outstanding allegations about Banerjee. His suspension ended in January 2002, and he was suspended by the Interim Orders Committee on 21 January 2002. On 9 September, Banerjee was found guilty of serious professional misconduct for the second time. The main findings related to financial dishonesty over a sustained period of time. He misled patients about the length of NHS waiting lists to induce patients to opt for private treatment and sought payments for treatments not performed. Concerns were also expressed about clinical skills.
Wilmshurst concludes
Banerjee's erasure from the Medical Register may remove the incentive in the eyes of some to investigate the outstanding issues. I, for one, would like to know how concerns about his honesty and clinical skills during a decade were not reflected in reports and employment references.
Academic institutions and the GMC Medical schools, universities, royal colleges, and specialist societies have key roles in setting the standards for medical practice in this country and for the award of qualifications. King's College, the University of London, and the Royal College of Surgeons are among the bodies that directly appoint non-elected members to the GMC. In this case some senior doctors and managers in these institutions concealed serious professional misconduct by doctors for a decade. Some allowed Banerjee to gain a qualification and an honour dishonestly. By so doing, they devalue the qualification others received from their institutions. It was not just that some turned a blind eye to the deceit, but some made whistleblowers feel threatened and others destroyed evidence. Would a judge shown to be involved in concealing crimes and perverting the course of justice be allowed to continue on the bench? Should King's College, the University of London, and the Royal College of Surgeons be allowed to continue to appoint non-elected GMC members?
The case of Banerjee and Peters is not an isolated one. I am aware of other cases under investigation by the GMC in which academic institutions, which appoint members to the GMC, refused to cooperate with the GMC's investigations into research fraud and other forms of misconduct by doctors employed in their institutions. It is difficult to believe that the decision not to cooperate with the GMC is made at a junior level. It seems likely that in some cases appointed members of the GMC are involved in the decision of their institution not to cooperate with the GMC's inquiries. At a time when there is restructuring at the GMC, the role of academic institutions in appointment of GMC members needs to be considered.

20 June 2014


In Prothonotary of the Supreme Court of New South Wales v Hendrick Jan van Es [2014] NSWCA 169 the NSW Court of Appeal has declared that Hendrick Jan van Es is not a person of good fame and character and is not a fit and proper person to remain on the Local Roll of Lawyers of the Supreme Court of New South Wales.

It was contended that van Es attempted to obtain an improper advantage by behaving deceitfully during the Legal Ethics for Barristers examination administered by the NSW Bar Association on 24 February 2012 and in lying to officers of the Bar Association when attempting to explain his actions. Specifically
(a) On 24 February 2012, as a candidate in the examination in Ethics for Barristers conducted by the Bar Association of New South Wales, the Opponent attempted to obtain an improper advantage by deceitfully:
(i) taking to his desk in the examination room materials which he was not permitted to use during the examination or the reading time for the examination;
(ii) referring to materials to which he was not permitted to refer during the examination or the reading time for the examination;
(iii) attempting to conceal from the invigilator, by turning them face down on his desk, materials to which he had been referring and which he was not permitted to use during the examination or the reading time for the examination;
(iv) refusing to allow the invigilator to examine the materials to which he had referred in the reading time for the examination;
(v) after leaving the examination room attempting to regain entry after concealing the prohibited material under his clothing and deceitfully inviting the invigilator to examine the materials he had brought to the examination;
(b) On 27 February 2012 at the premises of the NSW Bar Association the Opponent falsely denied to Philip Selth, Executive Director, NSW Bar Association and to Christopher D'Aeth, Director of Organisation and Development of the NSW Bar Association:
(i) that he had had unauthorised material with him in the examination room on 24 February 2012, and;
(ii) that he had done anything wrong on 24 February 2012 during his attendance at the Ethics examination conducted by the NSW Bar Association at the Bar Common Room.
The judgment states that
The respondent, Mr Hendrick Jan van Es, was admitted as a Lawyer of the Supreme Court of New South Wales on 17 February 2012. He does not hold a current Practising Certificate. On 22 August 2011 Mr van Es applied for registration to sit for all three NSW Bar Association Bar examinations to be held in February 2012. His registration was confirmed on 23 August 2011 and the NSW Bar Association subsequently provided Mr van Es with details of the examination materials, including general documentation concerning examination procedure, examination dates and times and reading lists.
On 31 October 2011, at his request, the NSW Bar Association sent Mr van Es an email setting out the material that had been permitted to be taken into both the examinations for Evidence and Ethics in July 2011. Mr van Es had been previously advised that the examination materials and formats were under review because a new version of the NSW Barristers' Rules had recently commenced.
The NSW Bar Association finalised the materials for the February 2012 Ethics examination in December 2011 and uploaded the relevant information to the area of its website dealing with examinations. The information included a sample cover page for the Ethics examination and listed the materials that would be permitted in the February 2012 examination.
(a) Mr van Es attends the Ethics examination on 24 February 2012
Mr van Es was one of 55 candidates who presented to sit the Ethics examination on 24 February 2012. The circumstances in which Mr van Es' conduct came to notice on that day was described in an affidavit dated 1 May 2013 made by Mr Christopher D'Aeth, Director of Professional Development Department of the NSW Bar Association. Mr D'Aeth was not cross-examined. In his affidavit, Mr D'Aeth states that he read from the 'Examinations Procedure' documentation as the candidates entered the room. Mr D'Aeth also notes that the permitted material for the examination was clearly set out on the cover page of the February 2012 Ethics examination paper.
During the 15 minutes reading time at the beginning of the examination period, Mr D'Aeth noticed that Mr van Es had with him an unusually large bundle of loose papers, which did not look like any of the permitted materials. Mr van Es appeared to be reading and "shuffling through" the loose papers. Upon being approached by Mr D'Aeth, Mr van Es turned over and covered the loose pages to which he had been referring. When Mr D'Aeth requested that Mr van Es show him his examination materials Mr van Es refused. Mr D'Aeth then informed Mr van Es that he would need either to show him his examination materials or be required to leave the examination room. Mr van Es proceeded to collect his materials and leave the examination room.
Some minutes later Mr van Es sought to speak with Mr D'Aeth outside the examination room, at which time he invited Mr D'Aeth to look at his examination materials. He said "I haven't left the building". It may be inferred that Mr van Es was seeking to re-enter the examination room to sit the examination. Mr D'Aeth informed him that as he had chosen to leave the examination room he would not be permitted to sit the examination and would need to register for the next examinations scheduled for July 2012.
Mr D'Aeth subsequently obtained CCTV footage taken from the cameras situated at the Bar Association reception and lift area between 9.30am and 9.45am on 24 February 2012. The footage showed Mr van Es leaving the examination room, and then attempting to open a door at the end of the corridor. He then sorted through his materials, extracted some papers from those materials and placed them down the front of his trousers, pulling his jumper down over them.
(b) Mr van Es meets with Messrs Selth and D'Aeth on 27 February 2012
The Executive Director of the NSW Bar Association, Mr Philip Selth, wrote to Mr van Es at 12.25pm on Monday 27 February requesting that they meet during the next three weeks to discuss his eligibility to sit the July Bar exams. Mr van Es arrived at the Bar Association's reception about 35 minutes later, without an appointment, and a meeting took place with Mr Selth and Mr D'Aeth. What follows is taken from Mr D'Aeth's affidavit and detailed file note of that meeting.
Mr van Es provided his version of events which included his anxiety on the day of the Ethics examination, that he had suffered a "panic attack", and that he had wished to return to the examination room to participate in the examination. Mr van Es said "I did not have unauthorised material with me in the examination room and I did nothing wrong". Only after Mr van Es was alerted to the fact that CCTV footage had captured his movements once he had left the examination room on the previous Friday did he offer an explanation for having hidden the material under his clothing. The file note records the following occurring thereafter:
"Mr van Es admitted he had removed items from the bag but said that they were his study notes and that they were in his bag in the examination room and were not with him at his examination desk nor in his folder of materials. Mr Selth indicated that such behaviour in an Ethics examination raised serious questions in our mind. Mr van Es indicated that he did not regard his behaviour as being part of the Ethics examination as he had left the examination room. Mr Selth indicated that he thought such an explanation was an exercise in semantics, especially as, at the time, Mr van Es was asking to return to the examination.
Mr Selth indicated that he considered this incident a serious matter - in particular misleading a member of staff - by asking Mr Selth to review his material knowing that material had been placed under his clothes - and the lack of candour. Mr Selth also indicated that he felt the explanation just given lacked candour; was not included or offered in the earlier explanation of events. In fact, it was not until Mr Selth revealed the presence of the camera footage that any explanation concerning the material he had hidden under his clothing was offered."
After that things continued to go pear shaped and provide teaching material for Law ethics teaching.

NSW Crim Law Appeals

The NSW Attorney-General has released the 328 page report [PDF] by the NSW Law Reform Commission regarding Criminal Appeals.

The Commission was asked to review the avenues of appeal in all criminal matters, with a view to simplifying and streamlining appeal provisions and consolidating them into a single Act.

Two principal Acts govern criminal appeals in NSW: the Criminal Appeal Act 1912 (NSW) (CAA, typically appeals from the higher courts to the Court of Criminal Appeal) and the Crimes (Appeal and Review) Act 2001 (NSW) (CARA, appeals from the Local Court), with judicial review  also available in some criminal proceedings under the Supreme Court Act 1970 (NSW) (SCA).

The report notes that
the limits of each Act are not well defined, and in some cases there is overlap. The CCA sits at the top of the criminal appeals hierarchy in NSW, although anomalously some criminal appeals currently lie to the Court of Appeal.
Criminal appeal provisions have been amended over the last century in a piecemeal manner, without fundamental review. This has resulted in a criminal appeals system which is at times complicated, inconsistent and outdated. We aim to update, simplify and streamline the criminal appeal provisions where possible.
The Commission recommends establishment of  a new Criminal Appeal Act -
Having two separate Acts creates a criminal appeals framework that is disjointed and complicated. Consolidating the CAA and CARA into a single Act will improve efficiency, clarity and accessibility. We recommend that the CAA and CARA be abolished and replaced with a single, new Criminal Appeal Act. (Recommendation 4.1)
Two aims of our terms of reference are to simplify and streamline appeal processes. To this end, we considered whether the criminal appeal provisions could be consistent across all courts in NSW. Ultimately, however, we have concluded that the differences between the courts mean that separate regimes of appeal remain practically unavoidable.
The CCA is constituted under the CAA. In contrast, the Court of Appeal and the Divisions of the Supreme Court are provided for under the SCA. This difference seems to be an historical anomaly. We recommend that the CCA be recognised in the SCA as a part of the Supreme Court. (Recommendation 4.2)
Judicial review from decisions in criminal matters currently lies to the Court of Appeal. Although this may be because the CCA is not formally a part of the Supreme Court, it means that both the CCA and the Court of Appeal have jurisdiction over criminal matters. If the CCA becomes a part of the Supreme Court, we also recommend that it should be assigned to hear judicial review applications arising out of criminal proceedings. (Recommendation 4.3)
The report discusses  appeals from the Local Court to the District Court
A conviction or sentence imposed in the Local Court may be appealed to the District Court. Only a small proportion of Local Court convictions and sentences are appealed, although in sentence appeals the success rate is quite high – on average about 60%.
The provision for conviction appeals works well and we do not recommend any change. However, sentence appeals are problematic in that the District Court exercises the sentencing discretion afresh, and may impose a different sentence on appeal even if the original sentence was within the range of acceptable options. It also does not usually have access to the Local Court’s remarks on sentence or any exchange between the magistrate and the bar table, and does not know why the Local Court chose a particular sentence over others.
In our view the current basis for determining sentence appeals does not assist with clarity or consistency in sentencing practice, or in promoting finality in criminal proceedings.
Ideally sentence appeals from the Local Court to the District Court should require error in order to succeed. However, the less formal nature of proceedings in the Local Court – necessary due to the high volume of cases and time pressures – means that an error based appeal is likely to be impractical. We instead recommend that appeals against sentence be by way of rehearing, on the basis of the material that was before the Local Court and the reasons of the magistrate. Fresh evidence should only be given by leave where it is in the interests of justice. (Recommendation 5.1)
The resources required for transcript production are a significant constraint in the hearing of appeals from the Local Court. We recommend that the Department of Attorney General and Justice investigate alternatives to the production of typed transcript in these appeals. (Recommendation 5.1)
In an appeal from the Local Court, the District Court judge may state a case on a question of law to the CCA. The case stated is an outdated and cumbersome method of reviewing a matter. We recommend that it be abolished and replaced with an avenue of appeal with leave on a ground involving a question of law. (Recommendation 5.2)
In relation to  appeals from the Local Court to the Supreme Court the Commission notes that
Appeal also lies to the Supreme Court from certain Local Court decisions. Although there are few such appeals, they play an important role in allowing the Supreme Court to determine questions of law authoritatively.
We recommend that the current avenues of appeal to the Supreme Court be retained, except that the ability to appeal against conviction or sentence on a question of fact or mixed fact and law should be removed. An appeal to the District Court can adequately deal with these factual questions. (Recommendation 6.1)
Where the Supreme Court hears an appeal from the Local Court, a further appeal lies to the Court of Appeal with leave. We recommend that this be abolished and replaced with an avenue of appeal to the CCA. (Recommendation 6.2) The CCA should have jurisdiction over all criminal appeals. Appeals from the Local Court – other issues (Chapter 7)
The Local Court, on application by either the prosecutor or defendant, can annul a conviction or sentence. We make some recommendations to increase the flexibility of this power, while at the same time balancing the need for finality. (Recommendations 7.1, 7.2, 7.3 and 7.4)
There is an established requirement in case law that a Parker direction must be given where a District Court judge is contemplating increasing a defendant’s sentence on appeal. We recommend including the requirement for a Parker direction in legislation. (Recommendation 7.5)
The District Court has limited powers in an appeal against conviction, and this has caused some problems in practice. We recommend that it be given some additional powers. (Recommendation 7.6)
A defendant cannot appeal to the District Court more than 3 months after the conviction or sentence. This can cause injustice, and we recommend that the District Court be able to grant leave to file an appeal more than 3 months after the conviction or sentence where exceptional circumstances are made out. We also recommend consistent time limits for appeals by defendants and the Director of Public Prosecutions (DPP). (Recommendation 7.7) The time limit for appealing to the Supreme Court is currently contained in procedural rules. We recommend it be moved into legislation. (Recommendation 7.8)
Where a forensic procedures order under the Crimes (Forensic Procedures) Act 2000 (NSW) is made, the order may be appealed to the Supreme Court as if it were a sentence. This is inconsistent with the avenues of appeal given to other decisions of the Local Court. We recommend that a forensic procedures order be subject to the same avenues of appeal and review as a conviction. (Recommendation 7.12)
There are no comprehensive procedural rules that apply to criminal appeals from the Local Court to the Supreme Court. This results in a gap in procedure, and criminal appeals have sometimes been treated as being subject to the Uniform Civil  Procedure Rules 2005 (NSW). We recommend that specific procedural rules, forms and fees be developed. (Recommendation 7.13)
We also recommend that particular provisions be clarified, including the award of costs, the effect of a sentence pending appeal and the power to deal with a good behaviour bond imposed on appeal. (Recommendations 7.9, 7.10, 7.11, 7.14 and 7.15)
In relation to appeals from conviction and sentence on indictment the Commission comments
 The grounds for an appeal against conviction on indictment have remained unchanged since their introduction in 1912. The wording of the provision is antiquated and its structure is unwieldy. The provision uses an outdated drafting style that is difficult to follow and apply. Judicial interpretation has not comprehensively clarified how the three grounds of appeal and the accompanying proviso should be applied. We conclude that there is scope for improving the provision.
Stakeholders agreed that the grounds for appeal against conviction should be reformed. We developed seven different options for reform, based on alternatives in other jurisdictions and suggestions arising from our consultations. These options were put to stakeholders.
We recommend a new formulation for the grounds of appeal against conviction. (Recommendation 8.1) Having considered the wide range of options, we recommend a formulation of the grounds for appeal against conviction that adopts the best features of those models with the most stakeholder support, and that provides a simple and clear framework.
In appeals against sentence for proceedings on indictment by the defendant and the Crown, the CCA is given a broad discretion in the legislation to impose any different sentence it thinks fit. However, the case law establishes that an error or miscarriage of justice must be demonstrated before the appeal can succeed.
We recommend retaining the current legislative provisions. (Recommendations 8.2 and 8.3) Stakeholders did not support codifying the case law as it risks constraining the discretion of the CCA and inadvertently restricting the grounds of appeal.
In discussing appeals from acquittal and similar orders the Commission recommends that where a defendant is acquitted in a judge alone trial for proceedings on indictment, the appeal should be available on questions of both law and fact, not just on a question of law. (Recommendation 9.1)
 In a judge alone trial the judge is required to give reasons, which include the findings of fact relied upon – something not available in a jury trial. Factual and legal errors can be discerned from the judge’s reasons. We expect this avenue of appeal will be rarely used. However, where there is a clearly identifiable error, community confidence in the criminal justice system is better served by having a method to  review and correct those errors. Consistent with this policy position the appeal should be decided on the ground that there was an error of law or fact that was material to the outcome. (Recommendation 9.1)
We recommend, by majority, that this expanded basis of appeal be available only where the offence for which the defendant was acquitted is punishable by 15 years imprisonment or more. (Recommendation 9.1) This is consistent with the threshold that applies to an order for a retrial under CARA where there has been a “tainted acquittal”.
We recommend expanding the avenue of appeal from an acquittal in the summary jurisdiction of the higher courts. (Recommendations 9.2 and 9.3)
No appeal lies from a decision of a judge to accept a plea in bar – a plea that the defendant has been convicted or acquitted of the same offence. The acceptance of the plea operates to discharge the defendant. We recommend that the DPP be able to appeal the acceptance of a plea in bar to the CCA. (Recommendation 9.4)
A person found not guilty by reason of mental illness may only appeal that verdict where he or she did not set up the defence. We reiterate the recommendations made in Report 138 that an appeal should be available regardless of who set up the defence. We also recommend that where a defendant is acquitted at a special hearing, the same avenues of appeal for an acquittal in an ordinary trial for proceedings dealt with on indictment should apply. (Recommendation 9.5)
Regarding other aspects of  appeals from higher courts the Commission indicates that
The legislation does not specify the basis on which a conviction or sentence appeal from the summary jurisdiction of the higher courts is to be decided. The CCA has held that these appeals should be decided the same way as appeals from proceedings dealt with on indictment. For clarity, we recommend including this basis in legislation. (Recommendation 10.1)
Most defendant appeals to the CCA require leave. In a conviction appeal, whether or not leave is required depends on whether the ground raises a question of law alone, a difficult classification. For simplicity, and to give the CCA greater control over the cases that come before it, we recommend that all appeals to the CCA should require leave. (Recommendation 10.2) We also recommend repealing r 4 of the Criminal Appeal Rules (NSW) and including its substance in legislation as one factor the CCA must consider in deciding whether to grant leave. (Recommendation 10.3). The ability for the trial judge to certify that a matter is appropriate for appeal is unnecessary and should be abolished. (Recommendation 10.4)
We recommend shortening the time limit for filing a notice of appeal with the CCA from 6 months to 4 months, in order to better serve the interests of finality. We also recommend that the Chief Justice develop a practice note for granting extensions of the notice of intention to appeal. Extensions of time are sometimes sought due to delays in obtaining transcripts and other material from the trial court, and we recommend that the head of each jurisdiction conduct a review of the processes for the release of this material. (Recommendation 10.5) For consistency we recommend that, except in certain cases, prosecution appeals be subject to the same time limits as those that apply to defendants. (Recommendation 10.6)
In certain proceedings the trial judge may submit a question of law arising during or after the hearing for determination by the CCA .The current avenues of appeal and our recommendations for change make this power unnecessary. We recommend that it be repealed. (Recommendation 10.9)
We also recommend clarifying and updating other parts of the appeals process, including the powers of the CCA following disposal of a conviction appeal, costs, supplemental powers and the effect of time spent on release pending a sentence appeal. (Recommendations 10.7, 10.8, 10.10, 10.11, 10.12 and 10.13)
Dealing with  Interlocutory appeals and appeals from committal proceedings the Commission states that
The current interlocutory appeal rights work well. We recommend retaining them in their current form and expanding them to apply to the summary jurisdiction of all higher courts. (Recommendation 11.1) We also make some recommendations to update and streamline these provisions, including by imposing a time limit and a requirement for leave for all parties. (Recommendations 11.2, 11.3 and 11.4)
There are currently two alternate avenues of appeal from an interlocutory order made in committal proceedings – to the CCA under the CAA, and to a single judge of the Supreme Court under CARA. We consider that dual avenues are unnecessary. We recommend abolishing the appeal to the CCA. (Recommendation 11.5)
In relation to  appeals to and from specialist courts the Commission states
 The Land and Environment Court (LEC) hears appeals from the Local Court relating to environmental offences. Although only a small number of appeals are made to the LEC each year, we recommend retaining this avenue of appeal. (Recommendation 12.1) There are benefits in having a specialist court deal with environmental offences. We recommend some changes to align appeals to the LEC with appeals to the District Court and Supreme Court. (Recommendations 12.2, 12.3 and 12.4)
Appeals relating to environmental offences may be made from the Local Court to the Supreme Court if the threshold for granting leave is met. We recommend this be retained. (Recommendation 12.5) 0.46 The Industrial Relations Commission in Court Session (IRCiCS) hears appeals from the Local Court for certain work health and safety offences. The provisions of CARA will apply. We do not make any specific recommendations for this avenue of appeal.
In an appeal from the Local Court to both the LEC and the IRCiCS, the judge hearing the appeal may state a case on a question of law to the CCA. Similar to our  recommendation for the case stated from the District Court, we recommend abolishing these provisions and replacing them with an avenue of appeal with leave on a ground involving a question of law. (Recommendations 12.6 and 12.10)
The provisions of CARA relating to criminal appeals from the Local Court apply to the Children’s Court. These avenues of appeal work well and we recommend retaining them. (Recommendation 12.7)
Appeals from decisions of the President of the Children’s Court lie to the Supreme Court instead of the District Court. This appears to be because the President must be a judge of the District Court. However, this creates an unnecessary anomaly and means a young person’s right of appeal can be different because the matter happens to be heard by a different judicial officer. We recommend that the President’s decisions be subject to the same avenues of criminal appeal as Children’s Court magistrates. (Recommendation 12.8)
Certain decisions of the Drug Court may be appealed to the CCA. These work well and we recommend that they be retained. (Recommendation 12.9)
Most prosecution appeals may be made only by the DPP or the Attorney General. The Environment Protection Authority (EPA) and the WorkCover Authority of NSW are specialist prosecutors. We recommend that they have the same criminal appeal rights as the DPP where they prosecuted the original proceedings. We also recommend that the EPA be given appeal rights for environmental offences where the original proceedings were prosecuted by or on behalf of a public authority. (Recommendation 12.11)
Highlighting other areas for reform the Commission notes
The Criminal Appeal Rules (NSW) apply to appeals to the CCA, and the Supreme Court Rules 1970 (NSW) govern criminal appeals from the Local Court to the Supreme Court. There is no clear rationale for having separate sets of rules. We recommend that the Supreme Court Rules Committee conduct a review of these rules with a view to consolidating and updating them. (Recommendation 13.1)
The Supreme Court Rules Committee makes rules for a number of different types of proceedings. We recommend that consideration be given to ensuring that criminal law expertise is available to the Committee when making criminal appeal rules. (Recommendation 13.1)
In criminal appeals from the Local Court to the Supreme Court it is not uncommon for there to be an application for judicial review in the alternative. However, there are some inconsistencies between the provisions applying to appeals and those that apply to judicial review. We recommend that the Attorney General instigate a review of the provisions of the SCA and other rules relating to judicial review, with a view to harmonising those provisions with similar provisions applying in criminal appeals. (Recommendation 13.2)

19 June 2014

No-care Data

The Guardian notes that UK NHS has "announced a rolling programme of spot checks on companies, charities, universities and government bodies that have received medical records" after an investigation uncovered "significant lapses" in the protection of patient confidentiality.

That investigation follows public and official expressions of concern earlier this year regarding the UK care.data initiative and the sale of ineffectively anonymised bulk health data, disregarding cautions provided in the Caldicott Report.

The Guardian comments that the UK Parliament's health select committee was unconvinced by the arguments put forward in February by the Health & Social Care Information Centre (HSCIC), operator of the 'care.data' central warehouse for health data, that patient privacy had been safeguarded.

The audit reportedly indicates that 3,059 data releases took place between 2005 and 2013. A detailed examination of 10% of those releases found "lapses in the strict arrangements that were supposed to be in place to ensure that people's personal data would never be used improperly". One research programme had no legal authority to get patient-identifiable data but was still accessing NHS records in 2014. A further eight were still getting mortality data (potentially enabling identification of individual patients) without approval.

There were "data sharing agreements" with three reinsurance companies that allowed reinsurers to continue to use the data until the agreements expired in 2015 and 2016. All three companies have now been asked to delete the medical records.

The HSCIC states that
Following an independent review into data releases made by our predecessor organisation the NHS Information Centre (NHS IC), our board has set out a series of steps to guarantee greater openness and reassurance to the public, stricter controls over data use and better clarity for data users.
These steps include:
  • Patients and public representatives will be part of a new membership of the HSCIC's data oversight committee, the Data Access Advisory Group (DAAG). 
  • All data agreements will be re-issued, to ensure activity is centrally logged, monitored and audited, resulting in a clear and transparent process. 
  • Decisions will be documented and published. 
  • A new, strengthened audit function will monitor adherence to data sharing agreements and halt the flow of data if there are any concerns exposed. 
  • A programme of active communication to the public and patients will help bring greater clarity about an individual's right to object to their data flowing to or from the HSCIC.
The review, led by Sir Nick Partridge and carried out by PricewaterhouseCoopers (PwC), was published [PDF] on 17 June 2014. It concluded there were significant administrative lapses in recording the release of data at the NHS IC.
Partridge commented that
It disappoints me to report that the review has discovered lapses in the strict arrangements that were supposed to be in place to ensure that people’s personal data would never be used improperly.
These lapses occurred before the HSCIC came into being and so it might be said that they are not the HSCIC’s fault. However, that is beside the point. The lapses are very much our responsibility to address. The HSCIC has a new Board and largely new senior executive team, but it inherited many of the NHS IC’s staff and procedures. Crucially it inherited information-sharing agreements with universities, companies, charities and other organisations that were given access to data by the NHS IC. Any lapses in the procedures for data released under the stewardship of the NHS IC during the eight years to 31st March 2013 may continue to have implications for the handling of the data today.
He went on to make recommendations
1) That the HSCIC undertakes a programme of work to ensure that data has been deleted appropriately for all data releases referenced in the PwC report, where the agreement has ended.
2) That the HSCIC develops one clear, simple, efficient and transparent process for the management of all data releases.
3) That the HSCIC implements a robust audit function, which will enable ongoing scrutiny of how data is being used, stored and deleted by those receiving it.
4) That the HSCIC publishes its policy, process and governance for the release of data.
5) That the HSCIC ensures there is clear, transparent and timely decision making, via the appropriate governance for all data releases, and that all decisions are documented and published on its website.
6) That the HSCIC implements a robust record keeping approach and that the details of all data releases (including the purpose for which they are released) are made available on its website.
7) That the HSCIC develops one Data Sharing Agreement, which is used for all releases of data, and which includes clear sanctions for any breaches.
8) That the HSCIC actively pursues a technical solution to allow access to data, without the need to release data out of the HSCIC to external organisations.
9) That the HSCIC quarterly Register of all data releases includes the number of law enforcement agencies’ person tracing requests processed by the National Back Office. The Register will also include all data being released under NHS IC data sharing agreements, ensuring it is providing a comprehensive account to the public of all data being shared.
The Guardian comments that
One set of records – which included a decade's worth of hospital data with patients' partial postcodes and partial date of birth, including month and year as well as gender, dates of admission, diagnosis, speciality, and treatment – went to French multinational reinsurer Scor. Another similar data set went to the UK subsidiary of the Reinsurance Group of America. Both were used to set "reinsurance premiums" for insuring critical illness conditions.
Another reinsurer Millman obtained two years of patient care data – detailing NHS number, age at start of hospital spell, gender, partial postcode, dates of admission, diagnosis, speciality, and treatment – to be used as part of a product sold to customers.
.... There was also apparent confirmation that a centralised database could be accessed by police to locate individuals. There were 12,733 "accepted and approved" approaches to the NHS, which led to 3,104 leads for officers. The HSCIC has said it will now report every quarter on requests from law enforcement, stressing that the data only reveals the location of the nearest GP and would only be given for investigations into serious crimes.

Big Bad Data

'Policing by Numbers: Big Data and the Fourth Amendment' by Elizabeth E. Joh in (2014) 89 Washington Law Review 35 argues that
The age of “big data” has come to policing. In Chicago, police officers are paying particular attention to members of a “heat list”: those identified by a risk analysis as most likely to be involved in future violence. In Charlotte, North Carolina, the police have compiled foreclosure data to generate a map of high-risk areas that are likely to be hit by crime. In New York City, the N.Y.P.D. has partnered with Microsoft to employ a “Domain Awareness System” that collects and links information from sources like CCTVs, license plate readers, radiation sensors, and informational databases. In Santa Cruz, California, the police have reported a dramatic reduction in burglaries after relying upon computer algorithms that predict where new burglaries are likely to occur. Unlike the data crunching performed by Target, Walmart, or Amazon, the introduction of big data to police work raises new and significant challenges to the regulatory framework that governs conventional policing. This article identifies three uses of big data and the questions that these tools raise about conventional Fourth Amendment analysis. Two of these examples, predictive policing and mass surveillance systems, have already been adopted by a small number of police departments around the country. A third example — the potential use of DNA databank samples — presents an untapped source of big data analysis. While seemingly quite distinct, these three examples of big data policing suggest the need to draw new Fourth Amendment lines now that the government has the capability and desire to collect and manipulate large amounts of digitized information.
'Privacy and Data-Based Research' by Ori Heffetz and Katrina Ligett in (2014) 28(2) Journal of Economic Perspectives 75–98 comments 
On August 9, 2006, the “Technology” section of the New York Times contained a news item titled “A Face Is Exposed for AOL Searcher No. 4417749,” in which reporters Michael Barbaro and Tom Zeller (2006) tell a story about big data and privacy: Buried in a list of 20 million Web search queries collected by AOL and recently released on the Internet is user No. 4417749. The number was assigned by the company to protect the searcher’s anonymity, but it was not much of a shield. No. 4417749 conducted hundreds of searches over a three-month period on topics ranging from “numb fi ngers” to “60 single men” to “dog that urinates on everything.” And search by search, click by click, the identity of AOL user No. 4417749 became easier to discern. There are queries for “landscapers in Lilburn, Ga,” several people with the last name Arnold and “homes sold in shadow lake subdivision gwinnett county georgia.” It did not take much investigating to follow that data trail to Thelma Arnold, a 62-year-old widow who lives in Lilburn, Ga. . . . Ms. Arnold, who agreed to discuss her searches with a reporter, said she was shocked to hear that AOL had saved and published three months’ worth of them. “My goodness, it’s my whole personal life,” she said. “I had no idea somebody was looking over my shoulder.” . . .“We all have a right to privacy,” she said. “Nobody should have found this all out.” 
Empirical economists are increasingly users, and even producers, of large datasets with potentially sensitive information. Some researchers have for decades handled such data (for example, certain kinds of Census data), and routinely think and write about privacy. Many others, however, are not accustomed to think about privacy, perhaps because their research traditionally relies on already-publicly-available data, or because they gather their data through relatively small, “mostly harmless” surveys and experiments. This ignorant bliss may not last long; detailed data of unprecedented quantity and accessibility are now ubiquitous. Common examples include a private database from an Internet company, data from a field experiment on massive groups of unsuspecting subjects, and confidential administrative records in digital form from a government agency. The AOL story above is from 2006; our ability to track, store, and analyze data has since then dramatically improved. While big data become difficult to avoid, getting privacy right is far from easy—even for data scientists.
This paper aims to encourage data-based researchers to think more about issues such as privacy and anonymity. Many of us routinely promise anonymity to the subjects who participate in our studies, either directly through informed consent procedures, or indirectly through our correspondence with Institutional Review Boards. But what is the informational content of such promises? Given that our goal is, ultimately, to publish the results of our research—formally, to publish functions of the data—under what circumstances, and to what extent, can we guarantee that individuals’ privacy will not be breached and their anonymity will not be compromised?
These questions may be particularly relevant in a big data context, where there may be a risk of more harm due to both the often-sensitive content and the vastly larger numbers of people affected. As we discuss below, it is also in a big data context that privacy guarantees of the sort we consider may be most effective. Our paper proceeds in three steps. First, we retell the stories of several privacy debacles that often serve as motivating examples in work on privacy. The first three stories concern intentional releases of de-identified data for research purposes. The fourth story illustrates how individuals’ privacy could be breached even when the data themselves are not released, but only a seemingly innocuous function of personal data is visible to outsiders. None of our stories involves security horrors such as stolen data, broken locks and passwords, or compromised secure connections. Rather, in all of them information was released that had been thought to have been anonymized, but, as was soon pointed out, was rather revealing.
Second, we shift gears and discuss differential privacy, a rigorous, portable privacy notion introduced roughly a decade ago by computer scientists aiming to enable the release of information while providing provable privacy guarantees. At the heart of this concept is the idea that the addition or removal of a single individual from a dataset should have nearly no effect on any publicly released functions of the data, but achieving this goal requires introducing randomness into the released outcome. We discuss simple applications, highlighting a privacy-accuracy tension: randomness leads to more privacy, but less accuracy.
Third, we offer lessons and reflections, discuss some limitations, and briefly mention additional applications. We conclude with reflections on current promises of “anonymity” to study participants—promises that, given common practices in empirical research, are not guaranteed to be kept. We invite researchers to consider either backing such promises with meaningful privacy-preserving techniques, or qualifying them. While we are not aware of major privacy debacles in economics research to date, the stakes are only getting higher.
'Governing, Exchanging, Securing: Big Data and the Production of Digital Knowledge' (Columbia Public Law Research Paper No. 14-390) by Bernard E. Harcourt comments 
The emergence of Big Data challenges the conventional boundaries between governing, exchange, and security. It ambiguates the lines between commerce and surveillance, between governing and exchanging, between democracy and the police state. The new digital knowledge reproduces consuming subjects who wittingly or unwittingly allow themselves to be watched, tracked, linked and predicted in a blurred amalgam of commercial and governmental projects. Linking back and forth from consumer data to government information to social media, these new webs of information become available to anyone who can purchase the information. How is it that governmental, commercial and security interests have converged, coincided, and also diverged in ways, in the production of Big Data? Which sectors have stimulated the production and mining of this information? How have the various projects aligned or contradicted each other? In this paper, I begin to explore these questions along two dimensions. First, I sketch in broad strokes the historical development and growth of the digital realm. I offer some categories to understand the mass of data that surrounds us today, and lay some foundation for the notion of a digital knowledge. Then, I investigate the new political economy of data that has emerged, as a way to suggest some of the larger forces that are at play in our new digital age.
‘The deluge’ by Fleur Johns in (2013) 1 London Review of International Law 9-34 comments
Scarcity is a critical adjuvant for international legal thought. Scarcity of water, diminishing forests, depleted natural resources; these are conditions about which international lawyers often worry. Yet abundance and proliferation are also sources of concern for international law. Mounting waste, rising obesity rates, the multiplying agendas of terrorist cells, an ever- mutating array of pathogens; a sense of ‘too much’ triggers as much global anxiety as ‘not enough’. 
Among the dimensions of excess by which the globe is said to be afflicted is a ‘data deluge’ being experienced globally. According to a May 2012 United Nations (UN) report, the world’s stock of digital data is expected to increase forty-four times between 2007 and 2020, doubling every twenty months. A new order of measurement has been coined to cope: the term zettabytes was introduced in 2010.2 This inundation is often greeted with awe. In scale and inevitability, it smacks of the sublime. Big data is said to define our age, even as it frequently exceeds our grasp. 
Data can be ‘big’ in a number of ways; in conceptual terms, in volume, in complexity. The term ‘big data’ alludes to the amassing and analysis of vast amounts of recombinable digital information that eludes corralling for a variety reasons. The ‘global data economy’, with which big data is often associated, is sometimes framed as an ‘economy of goods and ideas . . . that trades in personal information’ with consumer-monitoring, advertising and Internet- based transacting comprising its ‘backbone’. Elsewhere, the global data economy appears as a comprehensively reconfigured and recharged version of the pre-existing global economy, whereby processing and manufacturing times are reduced, performance analysis capacity intensified, product and service-customisation increased, decision-making optimised, and ‘entirely new business models’ invented thanks to the harnessing of big data. Visions of economic yield surrounding big data have a significant financial dimension as well. Imagining augmented databases, data sets or data analysis capacities as income-yielding assets raises the prospect of their financing and securitisation generating value, independently of any other business innovations with which they might be associated. 
At the forefront of the worries by which the term ‘big data’ is often accompanied is a sense that ‘stewardship’ is lacking in the assembly, storage, management, analysis, distribution, business or developmental deployment and monetisation of data. Particular concerns surround accumulations and transfers of personal data, that is, data traceable to and about a natural person. Along silent data streams all around us — being channelled, pooled, commodified, corrupted, diverted, erased—human freedom and agency are draining away, or so it is often supposed. 
Uneasiness abounds: surely someone, somewhere, in all this, needs to have a hand—or a coordinated group of hands—on some tiller? An invisible hand would suffice for some, but invocations of the market don’t always reassure. ‘The challenges are great, and will only be solved by focused effort and collaboration’, wrote Clifford Lynch, executive director of the Coalition for Networked Information, in Nature a few years ago. ‘As the volume of data, and the need to manage it grows, disciplinary consensus [and] leadership will be very powerful factors in addressing [those] challenges’, Lynch continued. Then again, ‘necessary community standards are lacking’, Lynch acknowledged. On what, then, might ‘disciplinary consensus’ rest? Indeed, which discipline or disciplines and which leader or leaders are, or should be, in play? 
Breathiness, glee and hope are, at the same time, plentiful in the proximity of the term ‘big data’. The unprecedented global ‘data flood’ is life-giving and value-generating in many accounts. Personal data flows are said to yield ‘the new “oil”’ for the twenty-first century and big data ‘a new asset class touching all aspects of society’, according to the influential World Economic Forum (WEF). The WEF has identified a ‘new wave of opportunity for economic and societal value creation’ with the vast masses of digital data being created by and about people the world over. This value-creation opportunity demands, according to the WEF, ‘a new way of thinking about individuals’. It also demands global legal reform. ‘Unlocking the full potential of data’ would, the WEF has argued, require redress of the ‘lack of global legal interoperability’ and resolution of ‘points of tension’ around privacy, ownership, transparency and value distribution. 
Development opportunities potentially associated with big data engender particular excitement. ‘At any one point in time and space’, the UN has observed, ‘such data may . . . provid[e] an opportunity to figuratively take the pulse of communities’, a possibility that is ‘immensely consequential for society, perhaps especially for developing countries’. Households in developing countries might, the UN has speculated, leverage real-time digital data to improve their access to food, tailor energy use, gain better access to micro-credit or other financial support, access health advice, and contribute to early warning mechanisms and social movements while benefiting from the same. A growing community of ‘mobile money intellectuals’ has highlighted the potential that mobile telephone infrastructure and associated data streams may hold for better integrating and servicing the poor in global financial services markets. Yet, social scientists working on these developments have also warned against their unreserved celebration, cautioning that ‘[t]he failure to link technological questions to normative political questions [and, I would add, legal questions] can lead to undesirable outcomes’. 
On the whole, policy speculations about the burgeoning data economy and related global development opportunities seem largely dominated by ‘big-push logic’ — a logic that has met with circumspection in development economics over the past decade. That logic ‘stresses that poor economies need some sort of large demand expansion, to expand the size of the market, so that entrepreneurs will find it profitable to incur the fixed costs of industrialization’ (or post-industrial infrastructure improvement) and suggests that ‘anything that stimulates demand will do’, including resource discovery. Critics of this logic have observed that natural resource booms are sometimes accompanied by declining per-capita GDP. 
Public international law has had much to say, for a long time, about the ‘big push’ of natural resource discovery and the struggles and responsibilities to which it may give rise. International law has been a key battleground for claim-making and norm-making in such contexts.If data are, indeed, the ‘resources’ likely to fuel much twenty-first century development, then one might expect data’s mining and monetisation—amid developing countries’ growing numbers of consumers especially—to elicit a new set of stakeholder claims, conflicts and challenges to which international law should already be attuned. One might anticipate, for example, the emergence of something akin to the doctrine of permanent sovereignty over natural resources put forward by Third World states in the context of the commodities boom of the 1970s. Data-oriented, collective claims have been advanced in debates surrounding access to vaccines, expressed as assertions of ‘viral sovereignty’ over a national population’s genetic data. Yet, no comparable claims appear to have yet been formulated or anticipated in relation to the economic developments identified with big data. Online protest about individuals’ treatment as commodities rather than consumers, and generic scholarly recognition of a ‘digital divide’: this seems more or less the extent of collective global ‘speaking back’ to the WEF’s sweeping, big data-centred vision and its like. 
Before being carried away too readily by the WEF’s ‘new wave of opportunity’, this article would have readers pause. The goal of this article is to initiate and lay some groundwork for a conversation about big data within public international law scholarship. Such a public international law conversation is never likely to cover the field — or rather intersecting fields — engaged by the theme of big data. Nonetheless, if media historian Lisa Gitelman is right that ‘every discipline . . . has its own norms and standards for the imagination of data’, then nascent orthodoxies may already be at work in global law and policy surrounding personal data that are helping to structure and shape the emergent global data economy, and might yet do so further. If so, then the ‘models of intelligibility’ surrounding data and the person that global policy-making is bringing to bear merit elucidation and critique. What are these models’ lawful dimensions and what could be their potential ramifications for public international law? What questions and difficulties might a WEF-evoked vision of ‘global legal interoperability’ towards enhanced data flow pose for public international lawyers? This article does not purport to answer these questions but rather to raise them (and some related questions), to highlight what may be at stake in addressing them, and to propose an agenda for their collaborative pursuit. In short, it contends that there is much more at issue in the governance of the emerging global data economy than technical interface between existing legal systems and well-aired privacy concerns. 
The first part of this article sets out some emergent orthodoxies by which much of the international legal and policy literature concerning the global data economy appears marked. In each case, it offers some grounds for calling those orthodoxies into question. The second part of this article identifies some questions that developments in the global data economy call upon public international lawyers to address in broad-ranging, counter-disciplinary collaboration.

17 June 2014

NSW Ag-Gag and Biosecurity

In Australia the SMH reports that Federal Agriculture Minister Barnaby Joyce has told the NSW Nationals annual conference that the national and state/territory governments are acting to protect farmers from camera-wielding “vigilantes”, who will be targeted by 'tough new biosecurity measures'. The Minister appears to envisage  something in the style of the US Ag-Gag statutes - noted elsewhere in this blog - that address "agri-terrorism".

Joyce is reportedly working with his state counterparts to crack down on "people putting cameras in piggeries, in dairies, coming in at night, stirring up the animals … using illegally obtained footage then putting it on the internet".

He will also help states to coordinate a response to farm trespassing and review the charity status of animal activist organisations: "Not only are they associated with a crime, they also have the hide to [say] ‘donate here and its tax deductible".

The proposed NSW "new legal biosecurity framework" features "much heavier penalties when it comes to trespass", albeit the framework documents do not seem to actually refer to trespass.

The SMH states that
 Last year, a worker at the Blantyre Farms piggery, near Young, found video equipment hidden in the ceiling vents of a shed. Owner Edwina Beveridge reportedly said her family’s privacy and business had been violated, and the invasion caused pigs to trample their young.
Activist groups rely heavily on secretly obtained footage to detect and publicise cases of animal abuse, arguing that regulation is not doing enough to protect animals.
Wally’s Piggery, near Yass, was forced to close after footage obtained by Animal Liberation NSW in 2012 caused a public outcry. It appeared to show pigs being bludgeoned and kept in filthy, cramped conditions. The owners have pleaded not guilty to animal cruelty and other charges.
Looking at  Lenah Game Meats and the Windridge Farms cases we might wonder whether existing law really is out of step.

NSW Primary Industry Minister Hodgkinson on 29 May announced that
“The draft framework outlines all the future legislative tools and powers needed to better manage biosecurity threats in NSW,”...
“This framework will be used to form a single piece of legislation, the NSW Biosecurity Act, which will wholly or partly replace 14 pieces of existing legislation. “The proposed changes will improve the State’s ability to manage animal and plant pests, diseases, contaminants and weeds in NSW by cutting red-tape for farmers and industry and strengthening our world class biosecurity systems.
“The NSW Liberals and Nationals recognise the need to create modern and innovative legislation that supports the national agreed principle that biosecurity is a shared responsibility among government, industries and individuals.”
Ms Hodgkinson said the release of the draft framework was the next step following the release of the NSW Biosecurity Strategy 2013-2021 last May.
“Key components of the proposed framework include an enhanced role of industry and community in preventing and minimising biosecurity threats as well as improved emergency and rapid response powers,” Ms Hodgkinson said.
“A biosecurity emergency requires swift and decisive action to protect the economy, environment and community, and this new legislation will minimise delays and reduce the impact of an emergency situation.“
It is expected that the Biosecurity statute will repeal the following Acts or parts of Acts and relevant regulations
  • Animal Diseases and Animal Pests (Emergency Outbreaks) Act 1991 (NSW)
  • Apiaries Act 1985 (NSW)
  • Deer Act 2006  (NSW)
  • Fertilisers Act 1985 (NSW)
  • Fisheries Management Act 1994 (NSW) Part 6 Division 4; Part 7 Division 6; Schedules 6B and 6C
  • Local Land Services Act 2014 (NSW) Part 10 - Pests
  • Non-Indigenous Animals Act 1987 (NSW)
  • Noxious Weeds Act 1993 (NSW)
  • Plant Diseases Act 1924 (NSW)
  • Stock (Chemical Residues) Act 1975 (NSW)
  • Stock Diseases Act 1923 (NSW)
  • Stock Foods Act 1940 (NSW)
  • Stock Medicines Act 1989 (NSW)  - authorisation and powers of inspectors 
  • Wild Dog Destruction Act 1921 (NSW)
The statute will not cover:
  • contamination risks arising from manufacturing or processing facilities (which will continue to be dealt with under the Protection of the Environment Operations Act 1997  (NSW))
  • animal welfare, except in relation to the licensing and keeping of animals presently dealt with under the Non-Indigenous Animals Act 1987  (NSW)
  •  the approval, management or utilisation of genetically modified crops, which will continue to be dealt with under existing State and Commonwealth legislation, or 
  • direct human health issues such as influenza and tuberculosis; but measures to mitigate the direct risks to human health arising from diseases, toxins and irritants produced by animals or plants will be included.
Meanwhile in Canada eight employees of Canada’s largest dairy have reportedly been suspended after animal rights campaigners released a video showing cows being viciously beaten and repeatedly kicked in the head. Video given to the British Columbia Society for the Prevention of Cruelty to Animals by the Mercy for Animals Canada group appears to show egregious misbehaviour involving chains, canes and rakes.

The Society's chief prevention and enforcement officer commented "It is important that producers have clear expectations around standards of care for farm animals and that there is a system in place to monitor and enforce these standards". The company is co-operating with an investigation but the Society believes criminal charges relating to animal cruelty should be laid.