Health Data

On May 3, 2021, the European Commission (the “Commission”) opened a further public consultation (“Consultation”) on the European Health Data Space (“EHDS”).

This follows a consultation earlier in the year, on the Commission’s “Inception Impact Assessment” in relation to the EHDS.  (For further information on the earlier consultation and an overview of the EHDS, please see our blog post available here).Continue Reading European Commission Conducts Further Consultation on the European Health Data Space Initiative

On February 9, 2021, the UK Government’s Department for Health and Social Care (“DHSC”) announced a review into the efficient and safe use of health data for research and analysis for the benefit of patients in the health sector (“Review”). The DHSC encourages stakeholder feedback in the context of the Review, and will be of particular interest to organisations that have, or seek to have, access to NHS patient data for research purposes.
Continue Reading UK Government Announces Review Into Use Of Health Data For Research And Analysis

The Federal Trade Commission (“FTC”) announced this month a proposed settlement against Flo Health, Inc. (“Flo”), the developer of popular menstrual cycle and fertility-tracking application (the “Flo App”), resolving allegations that “the company shared the health information of users with outside data analytics providers after promising that such information would be kept private.”  The proposed settlement requires Flo, among other things, to obtain review by an “independent third-party professional” of its privacy practices, obtain users’ consent before sharing their health information, alert users whose data was disclosed, and require third-parties that previously received that data to destroy it.
Continue Reading FTC Reaches Settlement with Digital Health App, Requires First Notice of Privacy Action

On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”).  The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.
Continue Reading European Commission Conducts Open Consultation on the European Health Data Space Initiative

On January 6, 2021 the UK’s Department of Health and Social Care (“DHSC”)  published “A Guide to Good Practice for Digital and Data-Driven Health Technologies” (the “Guidance”).  The Guidance updates the DHSC’s “Code of Conduct for Data-Driven Health and Care Technologies” (the “Code”) (for further information on the Code see our earlier blog, here).

As with the Code, the Guidance is a valuable resource to help parties understand what the National Health Service (“NHS”) looks for when acquiring digital and data-driven technologies for use in health and care.Continue Reading UK’s Department of Health and Social Care Publishes Updated Guidance on Good Practice for Digital and Data-Driven Health Technologies

On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020.

One of…
Continue Reading Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes

NHSX recently published “A Buyer’s Checklist for AI in Health and Care” (Guidance) that sets out 10 key questions which will be of use to parties deploying AI solutions or conducting data driven projects (in a health and care setting or otherwise).  For example, the Guidance…
Continue Reading NHSX Publishes “Buyer’s Checklist” for AI Solutions

On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020.  This joint announcement was made…
Continue Reading HHS Announces Enforcement Discretion Over the Implementation of Interoperability Final Rules Due to COVID-19 Public Health Emergency

On April 9, 2020, U.S. Department of Health and Human Services (“HHS”) issued a Notification of Enforcement Discretion (the “Notification”) regarding certain covered entities and business associates who choose to participate in the operation of a Community-Based Testing Site (“CBTS”) during the COVID-19 nationwide public health emergency. The Notification relaxes…
Continue Reading HHS Relaxes HIPAA Enforcement for Certain Covered Entities and Business Associates Regarding Their Participation in COVID-19 Community-Based Testing Sites

On April 3, 2020, the Department of Health and Human Services Office for Civil Rights (“OCR”) released an alert warning covered entities and business associates of an individual posing as an OCR Investigator to obtain protected health information. According to the alert, “[t]he individual identifies themselves as an OCR Investigator…
Continue Reading OCR Alert Warns Covered Entities and Business Associates of Potential PHI Scam