HIV policy in Italy and recommendations across the HIV care continuum.

The HIV epidemic has not yet ended, and there are ever more challenges: the recent Italian National Plan of Interventions against HIV and AIDS (Piano Nazionale di Interventi Contro HIV e AIDS (PNAIDS) 2017-2019) was hailed for its comprehensiveness. Its likelihood of success across the HIV care continuum was therefore assessed. Awareness interventions are sporadic and continue to miss high risk populations; if effectively implemented, the prescriptive detail in PNAIDS may help address this. Combined prevention needs greater focus and investment. However, there has been recent progress: free anonymous testing is available at multiple settings although improvements to provide access to key vulnerable populations are needed. Clinical management is available to a high standard across the country, with some areas for improvement in ensuring equality of access. Long-term management of people living with HIV is often effective, but discrepancies exist across regions and settings of care. It is recommended to enable implementation of PNAIDS as a matter of urgency, develop integrated awareness and testing interventions for STIs and HIV, make condoms free for high-risk populations, and develop a network of multidisciplinary services for long-term holistic care of people living with HIV.

Evaluación de los aspectos metodológicos, éticos, legales y sociales de proyectos de investigación en salud con datos masivos (big data) / Review of the methodological, ethical, legal and social issues of research projects in healthcare with big data

El actual modelo evaluador de la investigación con seres humanos depende básicamente de los procesos de toma de decisiones de los comités de ética de la investigación. Resulta prioritario que estos comités tomen conciencia de la relevancia del nuevo paradigma digital asentado en la explotación a gran escala de datos personales, incluidos los de salud. El artículo ofrece pautas para una adecuada evaluación de los proyectos que apliquen analítica de datos masivos en salud ante los cambios introducidos por el Reglamento General de Protección de Datos. Los procesos de recolección y explotación de datos constituyen el nicho donde desarrollar la investigación. En este contexto, los protocolos de obtención del consentimiento de los participantes han quedado claramente desfasados debido a que se presuponía no solo que los datos eran anónimos, sino que siempre lo seguirían siendo en el futuro. Por ese motivo, resulta imprescindible que los citados comités asimilen nuevas capacidades y procedan a una relectura de valores como la intimidad y la libertad, actualizando para ello protocolos, metodologías y procedimientos de trabajo. Este cambio de cultura de trabajo dotará de seguridad jurídica al personal implicado en las investigaciones, posibilitará que se garantice la protección de la intimidad de los titulares de los datos, y permitirá orientar la explotación de estos de tal forma que se evite la comercialización de conjuntos de datos personales en la era de la reidentificación, para que la investigación responda a las necesidades sociales y no a intereses espurios u oportunistas disfrazados de investigación

The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research

Investigación, salud pública y asistencia sanitaria en el Reglamento General de Protección de Datos de la Unión Europea y en la Ley Orgánica de Protección de Datos Personales y Garantía de los Derechos Digitales / Research, public health and healthcare in the General Data Protection Regulation of the European Union and in the Fundamental Law of Personal Data Protection and Guarantee of Digital Rights

Este trabajo analiza las consecuencias que tiene el inicio de la aplicación del RGPD y la aprobación de la LOPDGDD en la investigación biomédica, la salud pública y la asistencia sanitaria. Aborda el objetivo y el ámbito de aplicación del RGPD, la disociación y la seudonimización y su relevancia en la investigación y la salud pública. También examina la incorporación de los datos biométricos y de los datos genéticos dentro de las categorías especiales de datos personales y la definición que hace el RGPD de los datos de salud. Asimismo, analiza los supuestos de legitimación del tratamiento de categorías especiales de datos personales para asistencia sanitaria, la salud pública y la investigación en salud. Finalmente estudia las previsiones de la disposición adicional decimoséptima de la LOPDGDD que facilita la investigación sanitaria

This paper analyzes the consequences of the beginning of the application of the GDPR and the approval of the LOPDGDD in biomedical research, public health and health care. It addresses the objective and scope of the GDPR, decoupling and pseudonymisation and their relevance to research and public health. It also examines the incorporation of biometric data and genetic data within the special categories of personal data and the GDPR definition of health data. It also analyses the legitimisation of the processing of special categories of personal data for health care, public health and health research. Finally, it studies the requirements of the seventeenth additional provision of the LOPDGDD that facilitates health research

Policy forum. Data, privacy, and the greater good.

Large-scale aggregate analyses of anonymized data can yield valuable results and insights that address public health challenges and provide new avenues for scientific discovery. These methods can extend our knowledge and provide new tools for enhancing health and wellbeing. However, they raise questions about how to best address potential threats to privacy while reaping benefits for individuals and to society as a whole. The use of machine learning to make leaps across informational and social contexts to infer health conditions and risks from nonmedical data provides representative scenarios for reflections on directions with balancing innovation and regulation.

Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.

BACKGROUND: The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors' clinical information for research and regulatory purposes, and existing practices that limit research participants' ability to control what is done with their genetic data, amplify the privacy concerns. DISCUSSION: To date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public. SUMMARY: This paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that privacy risks associated with cell-based research and interventions should be addressed through evidence-based policy reforms that account for both well-established legal and ethical norms and current knowledge about actual or anticipated harms. The authors also call for research studies that identify and address gaps in understanding of privacy risks.

A systematic review and comparison of HIV contact tracing laws in Canada.

OBJECTIVES: Public health officials and health providers need to be aware of the legislation documenting contact tracing in their jurisdiction to advise HIV positive clients of their rights, and to systematically perform their duties. The objective is to outline and compare the contact tracing laws in 13 jurisdictions in Canada, and to provide policy recommendations. METHODS: A systematic review was performed to outline and compare the laws in Canadian jurisdictions regarding HIV contact tracing. Specific manual searches were done in websites of Canadian provincial and territorial departments of health. RESULTS: For thirteen provinces and territories within Canada eleven laws were found. No laws directly pertaining to partner notification or contact tracing were found in Newfoundland and Labrador or Quebec. CONCLUSIONS: Public health officials should ensure that contact tracing practices and policies accurately reflect the current regulations without compromising their patients' confidentiality. It is recommended that each province/territory would benefit from standardized contact tracing regulations which are imbedded in communicable disease legislation. Regulations with provisions for informed consent, confidentiality, multiple counselling sessions, clear procedures in duty to warn cases, and domestic violence screening would be considered best practice.

The uneasy ethical and legal underpinnings of large-scale genomic biobanks.

Abstract Large-scale genomic databases are becoming increasingly common. These databases, and the underlying biobanks, pose several substantial legal and ethical problems. Neither the usual methods for protecting subject confidentiality, nor even anonymity, are likely to protect subjects' identities in richly detailed databases. Indeed, in these settings, anonymity is itself ethically suspect. New methods of consent will need to be created to replace the blanket consent common to such endeavors, with a consent procedure that gives subjects some real control over what they might consider inappropriate use of their information and biological material. Through their use, these biobanks are also likely to yield information that will be of some clinical significance to the subjects, information that they should have access to. Failure to adjust to these new challenges is not only legally and ethically inappropriate, but puts at risk the political support on which biomedical research depends.

The elimination of anonymous HIV testing: a case study in North Carolina.

In May 1997, anonymous human immunodeficiency virus testing in publicly funded clinics was eliminated throughout North Carolina. There were concerns that this decision would disenfranchise testers with certain behavioral profiles. North Carolina's counseling and testing system was used to evaluate the effect of this policy change. A 10.3 percent decline in overall testing and a 21.7 percent decline among men who had sex with other men were identified in the year following the policy change. However, between 13 and 24 months after the policy change, the number of tests administered returned to near pre-policy levels. Understanding North Carolina's experience can assist others considering similar policy changes.