In a Bloomberg Law article, attorneys examined Washington State’s comprehensive new privacy law, the My Health My Data Act, the first state law that specifically safeguards consumer health data.

The article discusses the new law’s scope, applicability, and ensuing company obligations. The Act will apply to many life sciences companies, pharmaceutical and device

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

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

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

If 2021 is any indication, the Federal Trade Commission (FTC) shows no signs of slowing down in its pursuit of enforcement actions to address a wide variety of alleged privacy and cybersecurity issues. Under the leadership of new chair, Lina Khan, the past year has seen the FTC engage is a variety of new and expanding enforcement actions exhibiting an increasing interest in regulating data privacy and security, as well as other consumer protection areas.

While the FTC has become the de facto regulator for entities that are not subject to other sector-specific regulations, the Commission’s assertion of authority over privacy and cybersecurity matters is limited by its statutory powers under section 5 of the FTC Act, which prohibits “unfair or deceptive acts or practices” that injure consumers. The FTC’s expansion of that authority to cover privacy and cybersecurity matters has only grown more aggressive in recent years but has also become the subject of close judicial review. Notably, in 2018, the Eleventh Circuit ruled, in LabMD, Inc. v. FTC, that the FTC did not have unlimited authority to dictate the details of companies’ privacy and cybersecurity protections. Earlier this year, the Supreme Court, in AMG Capital Mgmt., LLC v. FTC, held that Section 13(b) of the FTC Act does not allow the FTC to obtain monetary relief in federal court. The FTC has asked Congress to use its authority to remedy this ability, and claims that this constitutes a loss of its “best and most efficient tool for returning money to consumers who suffered losses as a result of deceptive, unfair, or anticompetitive conduct.”

The FTC has pushed for a more expansive view of its authority for several years, and this has only intensified over the last year. Even before the AMG decision, the FTC had been advocating for Congress to address the gap in Section 13(b), which only explicitly provides for the FTC’s ability to order injunctive relief and is silent on monetary relief. While waiting on Congress to address the issue, we expect for the FTC to continue to bring enforcement actions and order restitution and disgorgement via their Section 19 authority, which provides for these types of relief, but only after a final cease-and-desist order, which can be challenged and is subject to review of appellate courts.Continue Reading FTC Signals Increased Focus on Privacy and Data Misuse