On December 20, 2023, the National Institute of Standards and Technology (“NIST”) National Cybersecurity Center of Excellence (“NCCoE”) published its Cybersecurity of Genomic Data report (the “Report”).  The Report aims to assist organizations in protecting against misuse of genomic data and enabling secure collaborative innovations.  Note, however, that the Report is not authoritative with respect to its assessment of the treatment of genomic data under the current U.S. regulatory framework, including with respect to the identifiability of such information.Continue Reading NIST Cybersecurity Center of Excellence – Cybersecurity of Genomic Data Report 

The past year has seen unprecedented growth and development of artificial intelligence (“AI”) tools, which have been significantly propelled by the rapid deployment of generative AI (“GenAI”) tools.  The health care and life sciences industries have increasingly sought the use of AI and GenAI tools to promote innovation, efficiency and precision in the delivery of treatment and care, as well as in the production of biologics and medical devices.  For example, AI tools may more accurately predict and analyze diagnostic test results and develop personalized treatments than traditional tools; may improve clinical trial design, eligibility screening and data analysis; may be used as a diagnostic tool in a clinical trial designed to assess the safety or efficacy of a medical device; and may be used to accelerate the drug development timeline.  While such uses raise inherent concerns regarding, among other things, the improper use and/or disclosure of personal information, the introduction and/or perpetuation of bias and discrimination, as well as data security, reliability, transparency and accuracy, there is currently no developed federal or cohesive state regulatory framework designed to minimize such risks.  Continue Reading The 2023 AI Boom Calls for Further Regulation of the Use of AI Tools in the Health Care and Life Sciences Industries

The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. In this episode, Digital Health Initiative co-lead and health care partner, Christine Moundas, interviews health care partner and member of the digital health group, David Peloquin. They discuss the legal challenges and potential solutions

On June 24, 2022, the U.S. Supreme Court issued its ruling in Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade and holding that there is no constitutionally protected right to abortion. The significance of the decision cannot be overstated. Dobbs not only rolled back the Court’s prior protection of reproductive rights, it also raised still-unanswered questions about the privacy of digital data and could lead to the overturning of other previous Court opinions that are similarly grounded in privacy interests. In sparking such questions, Dobbs appears to have reinvigorated a national conversation regarding the protection of personal information and, more generally, the need for stronger data privacy safeguards in the United States.Continue Reading Four Months after Dobbs, Privacy Concerns Remain in the Spotlight

On June 24, 2022, the Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, overturning precedent that protected access to abortion services before the point of fetal viability. Instead, the Supreme Court stated that state legislatures have the authority to regulate abortion, leading several states to enact laws banning the procedure

On April 8, 2022, the U.S. Food and Drug Administration (“FDA”) released a draft guidance document titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” The draft guidance, if finalized, would replace FDA’s 2014 final guidance document titled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” adding significant

Modern smartphones, wearables and internet-enabled devices are capable of monitoring heart rate, blood oxygen levels, steps taken, prescription adherence, and other vital health-related activities. Contrary to popular belief, HIPAA does not cover many of these applications and devices. On September 15, 2021, the Federal Trade Commission issued a Policy Statement attempting to assert authority to police that gap.  The Policy Statement explains the FTC’s view that the Health Breach Notification Rule applies to mobile health applications. This Policy Statement signals increasing FTC scrutiny designed to safeguard sensitive health data on a variety of modern technologies that consumers use to monitor and improve their health.
Continue Reading FTC Warns Health Apps and Connected Device Companies to Comply With Health Breach Notification Rule

The debate surrounding vaccine passports to assist with the easing of lockdown restrictions and controlling the spread of COVID-19 continues to raise a number of concerns in the UK.

Although the use of such passports is apparently under consideration, such proposals raise a number of different ethical, scientific and legal issues. A recent Royal Society report sounded a note of caution, suggesting that 12 tests should be met by any such proposal. Among other things, vaccine passports would need to meet various ethical and legal standards, including in respect of data protection.
Continue Reading Possible Use of COVID Vaccine Passports Raises Data Protection Concerns

UPDATE July 17, 2020: Representatives of the U.S., British and Canadian governments reported yesterday that Russian hackers affiliated with known hacking group APT29 (or “Cozy Bear”) are targeting attacks on health care organizations researching COVID-19 vaccines. Cozy Bear, previously involved in the 2016 hacking of the Democratic National Committee, has reportedly been using spear-phishing and malware in an effort to steal the research. This announcement comes on the heels of a spate of attacks against research universities and health care organizations in recent months, described below.”

While the pandemic has brought economic downturn to many industries, a recent uptick in data security breaches suggests business is booming for cybercriminals. Universities and health care institutions dealing with the coronavirus have been particularly targeted by hackers attempting to exploit the current climate of confusion, urgency, and stress. In this post, we discuss the attacks and provide steps organizations can take to prevent and respond to breaches.
Continue Reading Universities and Hospitals Facing Increased Cyber Attacks

On April 21, the European Data Protection Board (“EDPB”) released guidelines on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak (“Guidelines”).

The Guidelines note that the GDPR includes various provisions which permit health data to be collected and processed for scientific research purposes connected with COVID-19 and also envisages specific derogations to the prohibition on processing certain special categories of personal data, such as health data, where necessary for scientific research purposes.
Continue Reading European Guidelines Adopted on Health Data Processed in the Context of the Covid-19 Outbreak