Protecting Privacy of Pregnant and LGBTQ+ Research Participants.

This Viewpoint summarizes existing federal regulations aimed at protecting research data, describes the challenges of enforcing these regulations, and discusses how evolving privacy technologies could be used to reduce health disparities and advance health equity among pregnant and LGBTQ+ research participants.

Hacking HIPAA: "Best Practices" for Avoiding Oversight in the Sale of Your Identifiable Medical Information.

In light of the confusion invited by applying the label "de-identified" to information that can be used to identify patients, it is paramount that regulators, compliance professionals, patient advocates and the general public understand the significant differences between the standards applied by HIPAA and those applied by permissive "de-identification guidelines." This Article discusses those differences in detail. The discussion proceeds in four Parts. Part II (HIPAA's Heartbeat: Why HIPAA Protects Identifiable Patient Information) examines Congress's motivations for defining individually identifiable health information broadly, which included to stop the harms patients endured prior to 1996 arising from the commercial sale of their medical records. Part III (Taking the "I" Out of Identifiable Information: HIPAA's Requirements for De-Identified Health Information) discusses HIPAA's requirements for de-identification that were never intended to create a loophole for identifiable patient information to escape HIPAA's protections. Part IV (Anatomy of a Hack: Methods for Labeling Identifiable information "De-Identified") examines the goals, methods, and results of permissive "de-identification guidelines" and compares them to HIPAA's requirements. Part V (Protecting Un-Protected Health Information) evaluates the suitability of permissive "de-identification guidelines," concluding that the vulnerabilities inherent in their current articulation render them ineffective as a data protection standard. It also discusses ways in which compliance professionals, regulators, and advocates can foster accountability and transparency in the utilization of health information that can be used to identify patients.

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.

Personally Identifiable Information in State Laws: Use, Release, and Collaboration at Health Departments.

Despite benefits to sharing data among public health programs, confidentiality laws are often presumed to obstruct collaboration or data sharing. We present an overview of the use and release of confidential, personally identifiable information as consistent with public health interests and identify opportunities to align data-sharing procedures with use and release provisions in state laws to improve program outcomes. In August 2013, Centers for Disease Control and Prevention staff and legal researchers from the National Nurse-Led Care Consortium conducted a review of state laws regulating state and local health departments in 50 states and the District of Columbia. Nearly all states and the District of Columbia employ provisions for the general use and release of personally identifiable information without patient consent; disease-specific use or release provisions vary by state. Absence of law regarding use and release provisions was noted. Health departments should assess existing state laws to determine whether the use or release of personally identifiable information is permitted. Absence of direction should not prevent data sharing but prompt an analysis of existing provisions in confidentiality laws.