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On February 28, 2024, President Biden announced an Executive Order directing the Department of Justice to promulgate regulations that restrict or prohibit transactions involving certain bulk sensitive personal data or United States Government-related data and countries of concern or covered persons. The DOJ’s initially identified countries are China (including Hong Kong and Macau), Russia, Iran

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 

On November 13, 2023, New York Governor Kathy Hochul announced the release of proposed statewide hospital cybersecurity regulations that would require state-licensed hospitals to establish cybersecurity programs, policies and procedures (the “Proposed Regulations”). The Proposed Regulations feature requirements regarding cybersecurity policies and procedures, personnel, user authentication methods, security risk assessments, incident response plans, and two-hour

On July 20, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) sent warning letters to approximately 130 hospital systems and telehealth providers. The letters were intended to warn those entities of the privacy and security risks of online tracking technologies integrated into their websites and mobile applications. The agencies noted that the entities may be impermissibly disclosing consumers’ sensitive personal health information to third parties such as Meta/Facebook pixel and Google Analytics through the use of such online tracking technologies in potential violation of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended (collectively, “HIPAA”), the FTC Act, and/or the FTC Health Breach Notification Rule (“HBNR”).Continue Reading HHS and FTC Warning Letters Highlight Continued Scrutiny of Use of Online Tracking Technologies in Healthcare

Blackbeard may not be the first name that comes to mind when considering cybercrime, but prior international efforts to stop stateless rogue actors can point us toward the proper focus for cybersecurity—governments taking responsibility to solve a classic collective action problem by direct action, supporting existing industry defense measures, and leading multilateral cooperation efforts. This

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

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