[Health data in France: Abundant but complex]. / Les données de santé en France - Abondantes mais complexes.

TITLE: Les données de santé en France - Abondantes mais complexes. ABSTRACT: Alors que l'application de traçage des contacts (contact tracing) StopCovid (transformée à la mi-octobre 2020 en TousAntiCovid), débattue au Parlement1 en raison des inquiétudes qu'elle suscitait concernant la confidentialité des données personnelles et les libertés individuelles du fait qu'elle permet d'alerter un utilisateur s'il s'est trouvé à proximité d'une personne atteinte de la COVID-19, a été adoptée par près de 12 millions de personnes2, un dispositif concernant les données individuelles de santé, aux conséquences potentiellement beaucoup plus importantes pour les citoyens et leurs données personnelles, a commencé à se mettre en place suite à la Loi du 24 juillet 2019 (Loi n° 2019-774) relative à l'organisation et à la transformation du système de santé3 : la plateforme des données de santé, communément appelée Health Data Hub, constituée sous la forme d'un groupement d'intérêt public (GIP). Il ne s'agit plus de simplement signaler qu'on a croisé une personne anonyme infectée par le SARS-Cov-2, mais de réunir, dans une infrastructure informatique unique, un immense ensemble de données personnelles particulièrement sensibles concernant la totalité de la population française. Ce projet suscite désormais un certain intérêt médiatique et un début d'inquiétude. Mais cette inquiétude ne concerne presque uniquement que le fait que ces données sont déposées et gérées dans un cloud appartenant à une société américaine, un nuage informatique qui tombe sous le coup de la loi américaine de 2018 dite « CLOUD act4 ¼, qui ouvre la possibilité d'un transfert des données personnelles vers les États-Unis, comme s'en est inquiété récemment le Conseil d'État.5 Cet aspect est certes très important, mais il masque également de très nombreux enjeux liés au partage des données de santé, et qui sont largement méconnus de la population. Nous nous proposons de rappeler, tout d'abord, ce que sont les données de santé, ce qu'elles apportent et la nécessité d'en faciliter le partage, mais aussi les difficultés rencontrées pour leur accès et leur utilisation. Nous expliquerons ensuite, dans un deuxième article, en quoi cette plateforme des données de santé, telle qu'elle est conçue et pilotée par les pouvoirs publics pour répondre à ces difficultés et pour promouvoir l'intelligence artificielle en santé, est un projet qui soulève de fortes inquiétudes pour les citoyens et la société dans son ensemble. Même si les problèmes posés se présentent sous une forme différente selon les pays, notre propos concernera spécifiquement la situation en France.

Competing Ethical Interests Regarding Privacy and Accountability in Psychotherapy.

"Jane" is a mother of two, who was referred for psychotherapy. However, Jane had misgivings about engaging in the offered psychotherapy because of threats made by her domestically violent partner. The therapy sessions are audio recorded for the purpose of professional supervision and clinician reflective practices. Jane's partner had threatened to subpoena the therapy recordings to legally separate Jane from her children. This article focuses on how three different parts of Jane's multidisciplinary care (i.e. clinicians, policy professionals and medico-legal professionals) exhibit different competing ethical priorities. Psychotherapeutic clinicians private use of audio recordings of the therapy enhances patient care and their own professional development but with the risk of concealing possible unethical behaviour by either party. Medico-legal access to the therapy recordings preserves potentially relevant evidence in the pursuit of justice but risks the interpretation of the psychotherapeutic information outside of the therapeutic context. Policies advocating the inclusion of the therapy recordings in the medical record improves clinician (and health service) accountability but risks harming the vulnerable patient due to threats to patient-therapist confidentiality.

Becoming a Hybrid Entity: A Policy Option for Public Health.

When Congress passed HIPAA, it did not intend to constrain public health's data sharing in the same way as clinical or payers. In fact, HIPAA recognizes data sharing with public health as a matter of national priority and shields this function from its reach. However, a health department may offer services that bring it within HIPAA's purview, such as running a Children's Health Insurance Program or a laboratory that bills electronically. When this is the case, HIPAA requires all information and departments be subject to HIPAA unless the public health authority chooses to hybridize. Health departments might re-assess their coverage and elect to become a hybrid entity, thereby restricting HIPAA to only where required and removing barriers to information sharing with communities.

Keep Your Friends Close and Your Medical Records Closer: Defining the Extent to Which a Constitutional Right to Informational Privacy Protects Medical Records.

The following Article discusses the extent to which the constitutional right to informational privacy protects medical data from improper acquisition or dissemination by state agents. Part I provides background on Whalen v. Roe, the Supreme Court case that has been understood to establish the right to informational privacy. Part I also discusses the variations across the circuit courts as to what medical information is afforded protection by the right. Part II analyzes the well-established approaches adopted by the Second and Third Circuits as they present opposing interpretations of Whalen, one wholly protecting medical information and the other protecting scarcely any. Finally, Part III explains why the Supreme Court and courts that have yet to adopt a uniform approach should follow the Third Circuit and constitutionally protect all medical information from improper government acquisition or dissemination. Part III also argues for an amendment to the Privacy Act to provide individuals whose medical conditions are not afforded protection under the Constitution an alternative remedy.

Medical radiological procedures: which information would be chosen for the report?

AIMS AND OBJECTIVES: The aim of this study was to properly define the information regarding patient exposure to Ionizing Radiations in the radiological report, according to the European Directive 2013/59/EURATOM (EU 2013/59 art.58(b)). For this purpose, we evaluated the results from other Member States EU 2013/59 transpositions and from Guidelines recommendation published by International Organizations involved in diagnostic radiology. A practical way for implementing art.58 is also traced. MATERIALS AND METHODS: Dosimetric quantities, such as exposure, absorbed dose and effective dose which may be included in radiological report, were first analyzed; then, in order to define international state of art of Member States EU 2013/59 transposition, a Web research using French, English, Spanish and German key words was performed. RESULTS: EU 2013/59 transposition for 5 Member States was reported. Especially regarding art.58, a European project reports that few European countries (11 of 28) have identified the dose metrics to be used in radiological report. Scientific organizations supporting clinical radiologists and medical physicists have published Guidelines reporting parameters useful to quantify the radiation output and to assess patient dose. CONCLUSIONS: Our research revealed that there is not a shared interpretation of patient exposure information to be included in radiological report. Nevertheless, according to scientific community, authors believe that the exposure is the most appropriate information that could be included in radiological report. Alternatively, but with more expensiveness, a risk index based on effective dose could be used. Moreover, the systematic exposure information recorded could be useful for dose estimates of population from medical exposure.

Assessment of Doctors' Knowledge and Attitudes Towards Confidentiality in Hospital Care.

The physician's duty of confidentiality is based on the observance of the patient's privacy and intimacy and on the importance of respecting both of these rights, thus creating a relationship of confidence and collaboration between doctor and patient. The main objective of this work consists of analyzing the aspects that are related to the confidentiality of patients' data with respect to the training, conduct and opinions of doctors from different Clinical Management Units of a third-level hospital via a questionnaire. The present study aimed to define the problem and determine whether the opinions of these professionals correspond to those observed in a previous work conducted at the same center. Of the 200 questionnaires that were collected, 62.5% were from consultants and the rest were from residents (37.5%) with an average of 14.4 ± 12.5 years in professional practice. The respondents noted habitual situations in which confidentiality was breached in the reference hospital (74%). The section on their attitudes and behaviors towards situations related to confidentiality showed a slightly lower average score than that of their medical knowledge; significant differences in these scores were observed between the consultants and residents as well as between the extreme age groups (≤ 30 vs. ≥ 51 years) and years of professional practice, thus more inadequate attitudes were consistently noted in younger doctors who had fewer years of experience. Finally, the respondents answered that the training of doctors in the aspects of healthcare law and ethics was the most important measure that the hospital could adopt regarding confidentiality practices.

Should Immigration Status Information Be Included in a Patient's Health Record?

The documentation of immigration status in patient records poses a challenge to clinicians. On one hand, recording this social determinant of health can facilitate continuity of care and improved communication among clinicians. On the other, it might expose patients or their family members to immediate and unforeseen risks, such as being stigmatized and discriminated against by nonimmigrant-friendly clinicians or being exposed to immigration enforcement if staff contact immigration officials in violation of patient confidentiality. Patients may raise concerns about the purpose and risks of such documentation alongside fears about potential data sharing and violations of privacy and confidentiality. This commentary explores clinicians' options for documenting immigration status within the context of ethical, legal, and historical considerations in caring for stigmatized populations in changing political landscapes.

Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate.

Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of 'their' data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of research-absent in the GDPR-which can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational self-determination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy.

Access and Disclosure of Personal Health Information: A Challenging Privacy Landscape in 2016-2018.

OBJECTIVES: To assess the current health data access and disclosure environment for potential privacy-protecting mechanisms that enable legitimate use of personal health information while preserving the rights of individuals. To identify the gaps and challenges between increasing requests and expanding uses of such information and the regulations, technologies, and management practices that permit appropriate access and disclosure while guarding against harmful misuse of such information. METHODS: A scoping literature review focused on (1) regulations affecting access and disclosure of personal health information, (2) the uses of health information that challenge access and disclosure boundaries, and (3) privacy management practices that may help mitigate gaps in protecting patient privacy. RESULTS: Countries and jurisdictions are developing laws, regulations, and public policies to balance the privacy rights of individuals and the unprecedented opportunities to advance health and health care through expanded uses of health data. Regulations and guidance are evolving, but they are outpaced by the increasing demand for and the challenges of managing access and disclosure. Mechanisms such as consent and authorization may not always be adequate. Mechanisms that advance principled stewardship are more important than ever. CONCLUSIONS: Access and disclosure management are important dimensions of privacy management practices. This is a volatile period in which diverging public policies may reveal how best to balance access and disclosure of personal health information by individuals and by institutional custodians of the information. Approaches to access and disclosure management, including the roles of individuals, should be a focus for research and study in the years ahead.

Assessment of US Hospital Compliance With Regulations for Patients' Requests for Medical Records.

Importance: Although federal law has long promoted patients' access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process. Objective: To evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access. Design, Setting, and Participants: A cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017 US News & World Report Best Hospitals National Rankings. Exposures: Scripted interview with medical records departments in a single-blind, simulated patient experience. Main Outcomes and Measures: Requestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments. Results: Among the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for processing times. Conclusions and Relevance: The study revealed that there are discrepancies in the information provided to patients regarding the medical records release processes and noncompliance with federal and state regulations and recommendations. Policies focused on improving patient access may require stricter enforcement to ensure more transparent and less burdensome medical records request processes for patients.

Social workers have an obligation to all patients regarding confidentiality however, for some patients, the obligation is greater.

Social workers are held to many ethical obligations regarding patients including maintaining patient confidentiality and staying up to date on confidentiality laws, statutes, and regulations. As the landscape of health care continues to change, including the increased use of technology to maintain patient records, highlights this need. The changes in the regulations on confidentiality of those who are receiving substance use treatment, 42 CFR Part 2, are presented. The other regulations and laws covered include HIPAA, HITECH, and the ACA. This includes the changes that have taken place, how to be compliant, and which to follow when.

Specifics in the review of health documentation.

OBJECTIVES: The objective of the work was to identify if health documentation management is depending of actually current legislation. Also to review range and consistency records. The work described forms and content of documentation, relating to treat wounds and decubitus. METHODS: A content analysis of 139 health documentation of insurer of General Health Insurance Company, which were treated by 28 home care agencies (hereinafter "HCA") and in the HCA was done directly audit in 2012 and 2014. We set 29 assessment items, with criteria separation according structure, process and outcome. Documentation, we analyzed three ways: through 5 grade rating scale, by choosing a clear answer to the question: yes, no and evaluation of specific items of documentation. RESULTS: The research confirm dependence keeping medical records in home nursing care agencies from legislation. On the other hand, it was found that the form of the recording method of health care in many cases are varied and fragmented. Deficiencies were found in the area of criteria such as structure, process and outcomes and transparency in the management of documentation pressure ulcers and chronic wounds. Only 62.9 % of the documentations was written nursing care and sent to Health Insurance Company in full compliance or with minor shortcomings. CONCLUSION: Research has shown that in the legislation defined by standard forms was recorded the lowest number of deficiencies. This fact needs to be used for the development of new legislation, which directed to setting documentation with clearly defined, structured information's. WHO adopted the International Classification for Nursing Practice (ICNP) as essential and complementary part of professional health services (Tab. 2, Fig. 2, Ref. 22).

[Role of reporting and learning systems in the improvement of patient safety]. / A jelentési és tanulórendszerek szerepe a betegbiztonság javításában.

The principles and requirements of a patient safety related reporting and learning system were defined by the World Health Organization Draft Guidelines for Adverse Event Reporting and Learning Systems published in 2005. Since then more and more Hungarian health care organizations aim to improve their patient safety culture. In order to support this goal the NEVES reporting and learning system and the series of Patient Safety Forums for training and consultation were launched in 2006 and significantly renewed recently. Current operative modifications to the Health Law emphasize patient safety, making the introduction of these programs once again necessary.