Limitations for health research with restricted data collection from UK primary care.

PURPOSE: UK primary care provides a rich data source for research. The impact of proposed data collection restrictions is unknown. This study aimed to assess the impact of restricting the scope of electronic health record (EHR) data collection on the ability to conduct research. The study estimated the consequences of restricted data collection on published Clinical Practice Research Datalink studies from high impact journals or referenced in clinical guidelines. METHODS: A structured form was used to systematically analyse the extent to which individual studies would have been possible using a database with data collection restrictions in place: (1) retrospective collection of specified diseases only; (2) retrospective collection restricted to a 6- or 12-year period; (3) prospective and retrospective collection restricted to non-sensitive data. Outcomes were categorised as unfeasible (not reproducible without major bias); compromised (feasible with design modification); or unaffected. RESULTS: Overall, 91% studies were compromised with all restrictions in place; 56% studies were unfeasible even with design modification. With restrictions on diseases alone, 74% studies were compromised; 51% were unfeasible. Restricting collection to 6/12 years had a major impact, with 67 and 22% of studies compromised, respectively. Restricting collection of sensitive data had a lesser but marked impact with 10% studies compromised. CONCLUSION: EHR data collection restrictions can profoundly reduce the capacity for public health research that underpins evidence-based medicine and clinical guidance. National initiatives seeking to collect EHRs should consider the implications of restricting data collection on the ability to address vital public health questions.

Completeness of death registration in the Civil Registration System, India (2005 to 2015).

Background & objectives: In many developing countries including India, the civil registration data are incomplete, inadequate and not timely, therefore, compromising the usefulness of these data. The completeness of registration of death (CoRD) in the Indian Civil Registration System (CRS) was assessed from 2005 to 2015 at State level to understand its current status and trends over time and also to identify gaps in data to improve CRS data quality. Methods: CoRD for each year for each State was calculated from the CRS reports for 2005-2015. Data were analyzed nationally by geographic region and individual State. The availability of CoRD by age group and sex was also reported. Results: About 40 per cent increase in CoRD was documented for India between 2005 and 2015, with CoRD of 76.6 per cent in 2015. CoRD was >90 per cent in the western and southern regions and the eastern, central and northeastern regions had CoRD lower than the Indian average in 2015. Among the 29 States, 16 (55.2%) State had CoRD >80 per cent and five (17.2%) <50 per cent and 10 States recorded 100 per cent CoRD. Despite the highest per cent increase during 2005-2015 (108.5%), CoRD in Uttar Pradesh was 44.2 per cent in 2015. Varying levels of progress in 2015 were seen between the State with similar CoRD estimates in 2015. Nagaland (-63.3%), Manipur (-33.1%) and Tripura (-30.3%) were the only States that documented a decrease in CoRD during 2005-2015. The age non-availability for India ranged from 37.0 per cent in 2009 to 37.9 per cent in 2015, an average of 41.5 per cent over the seven years and was an average of 35.6 and 36.6 per cent for males and females, respectively. Age was available for all registered deaths only in five (17.2%) of the 29 States in 2009 and four (13.8%) in 2015. Sex non-availability for the recorded deaths was much lower as compared with that for age. Interpretation & conclusions: Despite the significant progress made in CoRD in India, critical differences between the States within the CRS remain, with poor availability of reporting by age and sex. Concentrated efforts to assess the strengths and weaknesses at the State level of the CRS processes, quality of data and plausibility of information generated are needed in India.

Genetic research and consent: On the crossroads of human and data research.

This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and therefore do not invoke the requirement of obtaining consent prior to using an individual's biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio-samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research.

Using Drones to Study Human Beings: Ethical and Regulatory Issues.

Researchers have used drones to track wildlife populations, monitor forest fires, map glaciers, and measure air pollution but have only begun to consider how to use these unmanned aerial vehicles to study human beings. The potential use of drones to study public gatherings or other human activities raises novel issues of privacy, confidentiality, and consent, which this article explores in depth. It argues that drone research could fall into several different categories: non-human subjects research (HSR), exempt HSR, or non-exempt HSR. In the case of non-exempt HSR, it will be difficult for institutional review boards to approve studies unless they are designed so that informed consent can be waived. Whether drone research is non-HSR, exempt HSR, or non-exempt HSR, it is important for investigators to consult communities which could be affected by the research.

The Dark Data Quandary.

The digital universe remains a black box. Despite attaining high-technology capabilities like artificial intelligence and cognitive computing, "Big Data" analytics have failed to keep pace with surging data production. At the same time, the falling costs of cloud storage and distributed systems have made mass data storage cheaper and more accessible. These effects have produced a chasm between data that is stored and data that can be readily analyzed and understood. Enticed by the promise of extracting future value from rising data stockpiles, organizations now retain massive quantities of data that they cannot presently know or effectively manage. This rising sea of "dark data" now represents the vast majority of the digital universe. Dark data presents a quandary for organizations and the judicial system. For organizations, the inability to know the contents of retained dark data produces invisible risk under a spreading patchwork of digital privacy and data governance laws, most notably in the medical and consumer protection areas. For courts increasingly confronted with Big Data-derived evidence, dark data may shield critical information from judicial view while embedding subjective influences within seemingly objective methods. To avoid obscuring organizational risk and producing erroneous outcomes in the courtroom, decision-makers must achieve a new awareness of dark data's presence and its ability to undermine Big Data's vaunted advantages.

Assessing and managing risk when sharing aggregate genetic variant data.

Access to genetic data across studies is an important aspect of identifying new genetic associations through genome-wide association studies (GWASs). Meta-analysis across multiple GWASs with combined cohort sizes of tens of thousands of individuals often uncovers many more genome-wide associated loci than the original individual studies; this emphasizes the importance of tools and mechanisms for data sharing. However, even sharing summary-level data, such as allele frequencies, inherently carries some degree of privacy risk to study participants. Here we discuss mechanisms and resources for sharing data from GWASs, particularly focusing on approaches for assessing and quantifying the privacy risks to participants that result from the sharing of summary-level data.

Towards coherent data policy for biomedical research with ELSI 2.0: orchestrating ethical, legal and social strategies.

As the recent inaugural Ethical, Legal, and Social Issues (ELSI) 2.0 conference made clear, the effects of information communication technology (ICT) are pervasive in biomedical research. Data initiatives are arising in all corners of biomedicine. Data sharing efforts already promised to surpass even the ambitious goals of the National Human Genome Research Institute, only 5 years after publication of its 10-year vision. ELSI research was established, in part, to address challenges of open data access and data sharing. However, by and large, ELSI research projects address particular concerns of a given population, jurisdiction, type of research practice or type of data. This does not necessarily facilitate coherent data policy for sustainable data stewardship. Forward-looking, data friendly strategies need to be considered. Orchestration strategies are needed which overcome barriers to collective action. Here we present challenges policymakers face, and suggest three basics steps towards meeting them. First, policymakers must recognise the systematic change that occurs when ICT enables dataflow itself to become an organising principle of biomedical research. Second, methods for identifying and gathering types of metadata suitable for ELSI research ought to be developed and regulated. Third, policymakers need to organise in ways that mirror the new vision for data-enabled research that data technologies are making possible, as ELSI 2.0 encourages researchers to do. Taking these steps will help ensure research evolves in ways that warrants trust of the public while still supporting widespread ethical access to necessary data, research subjects, samples and findings.

A critique of the regulation of data science in healthcare research in the European Union.

The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.

Quality of HIV Testing Data Before and After the Implementation of a National Data Quality Assessment and Feedback System.

CONTEXT: In 2010, the Centers for Disease Control and Prevention (CDC) implemented a national data quality assessment and feedback system for CDC-funded HIV testing program data. OBJECTIVE: Our objective was to analyze data quality before and after feedback. DESIGN: Coinciding with required quarterly data submissions to CDC, each health department received data quality feedback reports and a call with CDC to discuss the reports. Data from 2008 to 2011 were analyzed. SETTING: Fifty-nine state and local health departments that were funded for comprehensive HIV prevention services. PARTICIPANTS: Data collected by a service provider in conjunction with a client receiving HIV testing. INTERVENTION: National data quality assessment and feedback system. MAIN OUTCOME MEASURES: Before and after intervention implementation, quality was assessed through the number of new test records reported and the percentage of data values that were neither missing nor invalid. Generalized estimating equations were used to assess the effect of feedback in improving the completeness of variables. RESULTS: Data were included from 44 health departments. The average number of new records per submission period increased from 197 907 before feedback implementation to 497 753 afterward. Completeness was high before and after feedback for race/ethnicity (99.3% vs 99.3%), current test results (99.1% vs 99.7%), prior testing and results (97.4% vs 97.7%), and receipt of results (91.4% vs 91.2%). Completeness improved for HIV risk (83.6% vs 89.5%), linkage to HIV care (56.0% vs 64.0%), referral to HIV partner services (58.9% vs 62.8%), and referral to HIV prevention services (55.3% vs 63.9%). Calls as part of feedback were associated with improved completeness for HIV risk (adjusted odds ratio [AOR] = 2.28; 95% confidence interval [CI], 1.75-2.96), linkage to HIV care (AOR = 1.60; 95% CI, 1.31-1.96), referral to HIV partner services (AOR = 1.73; 95% CI, 1.43-2.09), and referral to HIV prevention services (AOR = 1.74; 95% CI, 1.43-2.10). CONCLUSIONS: Feedback contributed to increased data quality. CDC and health departments should continue monitoring the data and implement measures to improve variables of low completeness.

[Healthcare research in forensic commitment or poking around in the dark : Consensus paper on the necessity for more uniform and better data]. / Versorgungsforschung im Maßregelvollzug oder das Stochern im Nebel : Konsenspapier zur Notwendigkeit einheitlicher und besserer Daten.

Complex trends in occupancy determined by many influencing factors, clear state-specific differences in imprisonment practices as well as recently implemented statutory alterations to the appropriate paragraphs in criminal law, underline the necessity for qualitative high-grade concomitant research of German forensic commitment; however, neither the structural prerequisites nor an adequate data situation are currently present in order to do justification to this aim. Not even the total number of patients currently accommodated in forensic commitment can be elucidated from the publicized (partial) statistics. This consensus paper, which was formulated by three research institutes active at the state level, describes the limited possibilities for current forensic healthcare research and raises the demand for a nationwide uniform data situation on patients in forensic commitment. Furthermore, how the appropriate elicitation instrument should be organizationally and structurally achieved, is sketched from a scientific perspective. This article aims at initiating a discussion on a sustainable improvement in the prerequisites for healthcare research in German forensic commitment and targets a sensitization of decision makers in politics and administration for this topic.

[The EU Portal: Implementation, importance, and features]. / Das EU-Portal: Aufgaben, Bedeutung, Funktion.

The European Medicines Agency (EMA) is developing a web-based EU portal with a database "at Union level as a single entry point for the submission of data and information relating to clinical trials in accordance with" the new EU regulation No. 536/2014. The specifications are mostly published, but some documents are still missing. Because the project is integrated and has dependencies on other projects, this could result in other specification upgrades. The IT solution is under ongoing development until project completion in quarter III of 2019. The EU Portal and the database will be audited. If the audit is successful, the new regulation will come into force in October 2018. The use of the EU Portal will then be mandatory with some transition rules. The software development of the portal is restricted to the regulation and the derived requirements. It is not possible to implement any national requirements. We describe in this paper the current key functionalities of the portal and try to derive requirements for a national IT system.On 16.06.2017 the EMA Management Board announced that the development of the new portal has been delayed and it is foreseen that the new regulation can come into effect in 2019 at the earliest. The press release can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/06/news_detail_002764.jsp%26mid=WC0b01ac058004d5c1 (accessed: 12.07.2017).

[Implementation status of Regulation EU 536/2014 in the member states]. / Vorbereitungsstand zur EU Verordnung 536/2014 in den Mitgliedstaaten.

The upcoming Regulation EU 536/2014 for clinical trials of medicinal products for human use requires multinational cooperation in the assessment of clinical trial applications by the member states concerned as well as one single decision per member state concerned, supported by the new EU Portal and database system. The implementation makes national reorganisation of the processes necessary, especially coordination and cooperation between the national competent authorities and the ethics committees, necessary.A brief overview of implementation status with regard to national law adaptations, (re-) organisation, information technology systems as well as national or multinational pilot projects in 7 of 28 member states is given.Within these member states some national laws have been adapted already, while others will be soon. The national reorganisation covers mostly administrative organisation and coordination especially within the ethics committees. Overall, it is foreseen that a reduced number of ethics committees will be involved in the approval of clinical trials on medicinal products within the member states.Most of the seven member states expect that in addition to the new EU Portal/database system a national IT system for national cooperation and interaction will be necessary. Therefore, an interface within the EU system for national systems is essential.In order to test the new processes some member states are running national pilot projects or are planning them. In addition, almost all participate in the voluntary multinational assessment of clinical trials on medicinal products, which had existed since 2009, a few also in cooperation with their ethics committees.The member states are confident that all national processes will be in place when the EU regulation becomes applicable.

The Fitbit Fault Line: Two Proposals to Protect Health and Fitness Data at Work.

Employers are collecting and using their employees' health data, mined from wearable fitness devices and health apps, in new, profitable, and barely regulated ways. The importance of protecting employee health and fitness data will grow exponentially in the future. This is the moment for a robust discussion of how law can better protect employees from the potential misuse of their health data. While scholars have just begun to examine the problem of health data privacy, this Article contributes to the academic literature in three important ways. First, it analyzes the convergence of three trends resulting in an unprecedented growth of health-related data: the Internet of Things, the Quantified Self movement, and the Rise of Health Platforms. Second, it describes the insufficiencies of specific data privacy laws and federal agency actions in the context of protecting employee health data from employer misuse. Finally, it provides two detailed and workable solutions for remedying the current lack of protection of employee health data that will realign employer use with reasonable expectations of health and fitness privacy. The Article proceeds in four Parts. Part I describes the growth of self-monitoring apps, devices, and other sensor-enabled technology that can monitor a wide range of data related to an employee's health and fitness and the relationship of this growth to both the Quantified Self movement and the Internet of Things. Part II explains the increasing use of employee monitoring through a wide range of sensors, including wearable devices, and the potential uses of that health and fitness data. Part III explores the various regulations and agency actions that might protect employees from the potential misuse of their health and fitness data and the shortcomings of each. Part IV proposes two specific measures that would help ameliorate the ineffective legal protections that currently exist in this context. In order to improve employee notice of and control over the disclosure of their health data, I recommend the adoption of a mandatory privacy labeling law for health-related devices and apps to be enacted and enforced by the Federal Trade Commission (FTC). As a complementary measure, I also recommend that be amended so that its protections extend to the health-related data that employers may acquire about their employees. The Article concludes with suggestions for additional scholarly discussion.

Medicare Program: Expanding Uses of Medicare Data by Qualified Entities. Final rule.

This final rule implements requirements under Section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 that expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. This rule also explains how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. In addition, this rule implements certain privacy and security requirements, and imposes assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement required by the qualified entity program.

Quality Registries in Sweden, Healthcare Improvements and Elderly Persons with Cognitive Impairments.

Policy-makers, the medical industry and researchers are demonstrating a keen interest in the potential of large registries of patient data, both nationally and internationally. The registries offer promising ways to measure and develop operational quality within health and medical care services. As a result of certain favourable patient data regulations and government funding, the development of quality registries is advanced in Sweden. The combination of increasing demand for more cost-efficient healthcare that can accommodate the demographic development of a rapidly ageing population, and the emergence of eHealth with an increasing digitalisation of patient data, calls attention to quality registries as a possible way for healthcare improvements. However, even if the use of registries has many advantages, there are some drawbacks from a patient privacy point of view. This article aims to analyse this growing interdependence of quality registries for the healthcare sector. It discusses some lessons from the Swedish case, with particular focus on the collection of data from elderly persons with cognitive impairments.

Missed policy opportunities to advance health equity by recording demographic data in electronic health records.

The science of eliminating health disparities is complex and dependent on demographic data. The Health Information Technology for Economic and Clinical Health Act (HITECH) encourages the adoption of electronic health records and requires basic demographic data collection; however, current data generated are insufficient to address known health disparities in vulnerable populations, including individuals from diverse racial and ethnic backgrounds, with disabilities, and with diverse sexual identities. We conducted an administrative history of HITECH and identified gaps between the policy objective and required measure. We identified 20 opportunities for change and 5 changes, 2 of which required the collection of less data. Until health care demographic data collection requirements are consistent with public health requirements, the national goal of eliminating health disparities cannot be realized.