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, … Continue Reading
Senators Maria Cantwell (D-WA) and Bill Cassidy (R-LA) introduced bipartisan legislation this week to address privacy issues in the COVID-19 era. The proposal, entitled the “Exposure Notification Privacy Act,” would regulate “automated exposure notification services” developed to respond to COVID-19. This bipartisan legislation comes on the heels of dueling privacy proposals from both political parties. … Continue Reading
On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”). The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and … Continue Reading
On April 21, 2020, the Regulation on the Requirements and Reimbursement Process for Digital Health Applications (Digitale Gesundheitsanwendungen-Verordnung or „DiGAV“, available here) entered into force in Germany. Among other provisions, the DiGAV includes specific IT security and privacy requirements. Shortly after the law took effect, Germany’s Federal Medicines and Medical Devices Agency (“BfArM”) also released … Continue Reading
In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad … Continue Reading
On December 12, 2019, the European Parliament endorsed a non-binding resolution on enabling the digital transformation of health and care. The resolution calls on the European Commission to take a number of actions to foster the development of digital health systems in Europe to improve patient care and support research efforts — particularly those using … Continue Reading
On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure … Continue Reading
By Grace Kim and Siobhan Kahmann Following an informal consultation earlier this year – as covered by our previous IoT Update here – the UK’s Department for Digital, Culture, Media and Sport (“DCMS”) published the final version of its Code of Practice for Consumer IoT Security (“Code”) on October 14, 2018. This was developed by … Continue Reading
Covington’s global cross-practice Digital Health team has posted an illuminating three-part series on the Covington Digital Health blog that covers key questions entities should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. In the first part of the series, the Digital Health team answers key regulatory questions … Continue Reading
On our sister blog, CovingtonDigitalHealth, our global cross-practice digital health team has launched a three-part series on the key questions the technology, life sciences and communications industries should be considering as they fit together the regulatory and commercial pieces of the complex digital health puzzle. Read the first post in the series here.… Continue Reading
The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to … Continue Reading
In a new post on the Covington Digital Health blog, our colleagues discuss a new European Cloud in Health Advisory Council whitepaper calling for a review of European healthcare data protection rules holding back greater adoption of cloud computing and AI; and for more discussion about the ethics and governance of re-use of patient data for research and planning. To read … Continue Reading
