El ejercicio post mortem de los derechos de protección de datos personales en el ámbito sanitario / [The post-mortem exercise of personal data protection rights in the healthcare field]

La normativa de protección de datos no es clara a la hora de regular la diferencia entre el acceso a los datos personales del fallecido, y el acceso post mortem de cualquier contenido en formato digital de la persona fallecida. De la misma manera, hoy en día no existe ningún instrumento que permita reflejar la voluntad relativa al ejercicio futuro de los derechos del interesado. (AU)

The data protection regulation is not clear when it comes to regulating the difference between access to the personal data of the deceased, and post mortem access to any content in digital format of the deceased person. In the same way, today there is no instrument that allows reflecting the will regarding the future exercise of the rights of the data subject. (AU)

Principles of ideal diagnostic regulation and the IVDR.

This article discusses principles and concepts for ideal regulatory frameworks for diagnostics, and the expression of those principles in the EU IVDR. The authors present the benefits of regulatory frameworks and implementation approaches for diagnostics that are risk-based, globally convergent, connected, nimble and efficient, under the IVDR and with a future outlook. While many expressions of these principles can already be found in the EU IVDR text, and in its implementation approaches, their further embrace is needed in future EU diagnostic regulation. In the long term outlook, risk-based approaches can be extended to comprise entity-based excellence appraisals. Globally convergent approaches can be more explicit in e.g. qualification and classification of products. This will also help further reliance models. Better connections and cooperation between regulators across the healthcare spectrum including pharmaceuticals should be fostered. Nimble approaches such as Emergency Use Authorisations for pandemics are essential in highly regulated schemes like the IVDR and beyond. Finally, regulatory efficiency as in timely availability of IT infrastructure and oversight mechanisms is a distinguishing attribute of globally competitive diagnostic regulatory schemes. All the above needs consideration in the long term efforts to modernize the EU regulatory system, so that diagnostics can play their important role in clinical research as well as along the entire care continuum in the EU.

Unexpected Inequality: Disparate-Impact From Artificial Intelligence in Healthcare Decisions.

Systemic discrimination in healthcare plagues marginalized groups. Physicians incorrectly view people of color as having high pain tolerance, leading to undertreatment. Women with disabilities are often undiagnosed because their symptoms are dismissed. Low-income patients have less access to appropriate treatment. These patterns, and others, reflect long-standing disparities that have become engrained in U.S. health systems. As the healthcare industry adopts artificial intelligence and algorithminformed (AI) tools, it is vital that regulators address healthcare discrimination. AI tools are increasingly used to make both clinical and administrative decisions by hospitals, physicians, and insurers--yet there is no framework that specifically places nondiscrimination obligations on AI users. The Food and Drug Administration has limited authority to regulate AI and has not sought to incorporate anti-discrimination principles in its guidance. Section 1557 of the Affordable Care Act has not been used to enforce nondiscrimination in healthcare AI and is under-utilized by the Office of Civil Rights. State level protections by medical licensing boards or malpractice liability are similarly untested and have not yet extended nondiscrimination obligations to AI. This Article discusses the role of each legal obligation on healthcare AI and the ways in which each system can improve to address discrimination. It highlights the ways in which industries can self-regulate to set nondiscrimination standards and concludes by recommending standards and creating a super-regulator to address disparate impact by AI. As the world moves towards automation, it is imperative that ongoing concerns about systemic discrimination are removed to prevent further marginalization in healthcare.

Moving somatic gene editing to the clinic: routes to market access and reimbursement in Europe.

Somatic gene editing (SGE) holds great promise for making genetic therapy possible for many monogenic conditions very soon. Is our current system of European market authorization and reimbursement ready for the expected tsunami of gene therapies? At a recent workshop of the Netherlands ZonMw consortium on ethical, legal, and social implications of personalized medicine, we discussed the current possibilities for bringing new gene therapies to the clinic. In Europe, it is not yet clear whether the route via the European medicines agency as an advanced therapy medicinal product is the most appropriate for evaluation of highly personalized SGE applications, although this may optimally guarantee safety and effectiveness. Compassionate use may ensure faster access than the centralized procedure but does not stimulate the commercial development of products. Prescription to named patients may only provide adequate access for single patients. Temporary authorization of use may allow access to medication half a year before formal market authorization has been granted, but may also have large budget impacts. Magistral compounding under a hospital exemption may be an attractive solution for rare, tailor-made applications at an acceptable price. To approve local experimental use of a therapy on a case-by-case basis may be fast, but does not guarantee optimal safety, effectiveness, and broad implementation. We argue that alternative routes should be considered for products developed for a market of large groups of patients versus unique personalized treatments. A balance between scientific evidence for safety and effectiveness, affordability, and fast access may demand a range of alternative solutions.

Challenges to sovereign ambitions: forces of convergence and divergence within the global pharmaceutical sector and the UK's withdrawal from the European Union.

This paper maps key regulatory, governance and legal challenges associated with the UK's withdrawal from the European Union (EU) in terms of convergent and divergent pressures within the global pharmaceutical sector. These include (i) convergent regulatory pressures associated with the European framework for pre-market licensing; (ii) convergent and divergent industry pressures with regard to drug discovery and manufacturing; and (iii) divergent and convergent market pressures associated with the supply, pricing and assessment of medicines. The UK's sovereign ambitions risk a loss of influence over the licensing and surveillance of pharmaceuticals under convergent regulatory and industry pressures to engage in unilateral participation in the European regime. Further, they also risk a loss of influence over processes for pricing and assessing the effectiveness of new treatment regimens under divergent market pressures from larger pharmaceutical markets outside the EU, notably the United States.

The French Cochlear Implant Registry (EPIIC): General indicators.

Cochlear and brainstem implants have been included on the list of reimbursable products (LPPR) in France since March of 2009. The implants were initially inscribed for 5 years, after which an application for renewal with the French National Commission for the Evaluation of Medical Devices and Health Technologies (Commission Nationale d'évaluation des dispositifs médicaux et des technologies de santé - CNEDiMTS) was required [Haute Autorité de santé, 2009]. Upon registration to the list of reimbursable products, the companies and the reference centers for cochlear and brainstem implants were asked to set up a post-registration registry called EPIIC. This article reports the evolution in the EPIIC registry of the general indicators for 5051 patients over the five years from 2012-2016.

[Risk-based analysis in the handling of sensitive data in the health sector].

This contribution delves into the EU Regulation 2016/679 that defines the accountability of data controllers, with regard to the processing of personal data, and imposes the adoption of technological and organizational measures demonstrating a full commitment to European data protection laws. A risk-based analysis and an impact-based approach are recommended for all personal data, and especially those concerning health, in order to safeguard the rights and freedoms of the data subjects. The article also describes the processes that should be put in place to avoid errors and violations in the handling of personal data, which can result in physical, material or non-material damage to natural persons. The controller, in fact, needs to evaluate the situation carefully and follow a series of compulsory steps to assess any potential weaknesses in the system. A balancing act between public health concerns and privacy protection is necessary; this can be obtained through a detailed analysis of the norms and their careful implementation.

[Direct-to-consumer genetic testing: a regulation by the market, or a medical regulation?] / Les tests génétiques en libre accès - Régulation par le marché, ou régulation médicale ?

The direct-to-consumer genetic testing (DTC-GT) market has been developing for about twenty years now, raising various debates, even controversies. But what about the regulation of these so-called "innovative" devices, but whose medical status is ambiguous? A first regulatory aspect is depending on the market itself, since the latter is currently subjected to a strong structuring process. A second regulatory aspect, more classical, is the legal one. While the DTC-GT status has long been unclear on European scale, a new text (a Regulation, not a Directive) is modifying the situation. It encourages regulation "by the market" rather than "by the medical profession", which does not imply that the latter will have no (indirect) impact on the DTC-GT market.

TITLE: Les tests génétiques en libre accès - Régulation par le marché, ou régulation médicale ? ABSTRACT: Le marché des auto-tests génétiques se développe depuis une vingtaine d'années, non sans soulever des débats, voire des controverses. Qu'en est-il de la régulation de ces dispositifs dits « innovants ¼, mais dont le statut médical est ambigu ? Un premier aspect régulatoire vient du marché lui-même, puisqu'il est en cours de forte structuration. Un second aspect régulatoire relève plus classiquement du juridique. Alors que le statut des auto-tests a longtemps manqué de clarté à l'échelle européenne, un nouveau texte (un Règlement, et non une Directive) change la situation. Il encourage une régulation « par le marché ¼, plutôt que « par la profession médicale ¼, ce qui n'implique pas que cette dernière n'aura aucun impact (indirect) sur le marché des auto-tests.

Industry Payment to Vascular Neurologists: A 6-Year Analysis of the Open Payments Program From 2013 Through 2018.

Background and Purpose- Industry payments to physicians raise concerns regarding conflicts of interest that could impact patient care. We explored nonresearch and nonownership payments from industry to vascular neurologists to identify trends in compensation. Methods- Using Centers for Medicare and Medicaid Services and American Board of Psychiatry and Neurology data, we explored financial relationships between industry and US vascular neurologists from 2013 to 2018. We analyzed payment characteristics, including payment categories, payment distribution among physicians, regional trends, and biomedical manufacturers. Furthermore, we analyzed the top 1% (by compensation) of vascular neurologists with detailed payment categories, their position, and their contribution to stroke guidelines. Results- The number of board certified vascular neurologist increased from 1169 in 2013 to 1746 in 2018. The total payments to vascular neurologist increased from $99 749 in 2013 to $1 032 302 in 2018. During the study period, 16% to 17% of vascular neurologists received industry payments. Total payments from industry and mean physician payments increased yearly over this period, with consulting fee (31.1%) and compensation for services other than consulting (30.7%) being the highest paid categories. The top 10 manufacturers made the majority of the payments, and the top 10 products changed from drug or biological products to devices. Physicians from south region of the United States received the highest total payment (38.72%), which steadily increased. Payments to top 1% vascular neurologists increased from 64% to 79% over the period as payments became less evenly distributed. Among the top 1%, 42% specialized in neuro intervention, 11% contributed to American Heart Association/American Stroke Association guidelines, and around 75% were key leaders in the field. Conclusions- A small proportion of US vascular neurologists consistently received the majority of industry payments, the value of which grew over the study period. Only 11% of the top 1% receiving industry payments have authored American Heart Association/American Stroke Association guidelines, but ≈75% seem to be key leaders in the field. Whether this influences clinical practice and behavior requires further investigation.

Analysis of Open Payments Receipts Among Surgical Faculty at a Large Academic Institution.

BACKGROUND: Section 6002 of the Affordable Care Act, commonly referred to as "The Sunshine Act," is legislation designed to provide transparency to the relationship between physicians and industry. Since 2013, medical product and pharmaceutical manufacturers were required to report any payments made to physicians to the Centers for Medicare and Medicaid Services (CMS). We predicted that most clinical faculty at our institution would be found on the Open Payments website. We elected to investigate payments in relationship to divisions within the department of surgery and the level of professorship. METHODS: All clinical faculty (n = 86) within the department of surgery at our institution were searched within the database: https://openpaymentsdata.cms.gov/. The total amount of payments, number of payments, and the nature of payments (food and beverage, travel and lodging, consulting, education, speaking, entertainment, gifts and honoraria) were recorded for 2017. Comparison by unpaired t-test (or ANOVA) where applicable, significance defined as P < 0.05. RESULTS: Of the 86 faculty studied, 75% were found within the CMS Open Payments database in 2017. The mean amount of payment was $4024 (range $13-152,215). Median amount of payment was $434.90 (range $12.75-152,214.70). Faculty receiving outside compensation varied significantly by division and academic rank (P < 0.05). Plastic surgery had the highest percentage of people receiving any form of payment ($143-$1912) and GI surgery had the largest payments associated with device management ($0-$152,215). The variation seen by rank was driven by a small number of faculty with receipt of large payments at the associate professor level. The median amount of payment was $428.53 (range $13.97-2306.05) for assistant professors, $5328.03 (range $28.30-152,214.70) for Associate Professors, and $753.82 (range $12.75-17,708.65) for full professors. CONCLUSIONS: Reporting of open payments to CMS provides transparency between physicians and industry. The significant relationship of division and rank with open payments database is driven by relatively few faculty. The majority (94%) received either no payments or less than $10,000.

PUBLIC PROCUREMENT IN THE HEALTHCARE SECTOR: ADAPTATION OF THE ADMINISTRATIVE LEGISLATION OF UKRAINE TO THE EU LEGISLATION.

The article examines the issue of public procurement in the healthcare sector through the prism of the Association Agreement with the EU. The emphasis is on the ensuring mutual access to the markets of public procurement of the EU and Ukraine on the basis of planned and consistent approximation of Ukrainian legislation in the field of public procurement to the EU acquis in the field of public procurement. The purpose of this article is to identify the peculiarities of the reform in the field of public procurement in Ukraine, to search for drawbacks in the administrative legislation of Ukraine, which is governing public procurement in the healthcare sector in the context of Ukraine's implementation of the Association Agreement with the EU, and to justify its improvement. The subject of research is the social relations that arise in the implementation of public procurement in the field of health. The methodological basis of the conducted research is the general methods of scientific cognitivism as well as concerning those used in legal science: methods of analysis and synthesis, formal logic, comparative law, statistical methods etc The following main directions of reforming the system of public procurement were established. It has been proved that CPO functioning on the national level of government in the form of a state-owned enterprise under the control of one of the relevant ministries is non-feasibility. The advantages of the ProZorro electronic procurement system and the state of implementation of the provisions of the EU Directives on 2014/23/ EU, 2014/24/ EU, 2014/25/EU, 2014/55/EU into the administrative legislation of Ukraine have been identified. It has been found that in March, 2015 centralized procurement system for medicines and medical products was changed in Ukraine to use the funds of the State Budget of Ukraine for the purchase of medicines and medical products with the involvement of international specialized organizations. On December 21, 2018 the Verkhovna Rada (Supreme Council) of Ukraine put amendments into the Law of Ukraine "On Public Procurement". The attention is paid to the novelties of this Law. It has been found that the legislation of Ukraine has such shortcomings: 1) in Ukraine the issue of clear distribution of functions of the authorities authorized to carry out control in the field of public procurements remains unresolved; 2) the norms of the Law contradict each other; 3) the problems of creating effective mechanisms for the formation of the nomenclature of medicines still remain, as well as their supplies to healthcare institutions.