Elizabeth Brim is an associate in the firm’s Washington, DC office. She is a member of the firm’s Health Care and Data Privacy and Cybersecurity Practice Groups, advising clients on a broad range of regulatory and compliance issues. In addition, Elizabeth maintains an active pro bono practice.

On April 6, 2022, the Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) published a request for information (“RFI”) seeking public comment on implementing certain provisions of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, indicating that a rulemaking or further guidance related to the HITECH Act may be forthcoming.  Specifically, the RFI seeks input as to how covered entities and business associates are voluntarily implementing recognized security practices.  OCR will consider the implementation of such practices when making certain determinations relating to the resolution of potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule.  The RFI also seeks input on the process for distributing to harmed individuals a percentage of civil monetary penalties (“CMPs”) or monetary settlements collected pursuant to the HITECH Act.  Although HIPAA does not provide a private right of action, the potential for sharing in monetary penalties or settlements could incentivize individuals to report potential HIPAA violations to OCR.

Continue Reading OCR Seeks Comments Related to Recognized Security Practices and Distribution of Civil Monetary Penalties under the HITECH Act

On January 21, the Federal Trade Commission (“FTC”) announced new resources to help companies determine their obligations under the Health Breach Notification Rule (the “Rule”): the Health Breach Notification Rule: Basics for Business, which provides a quick introduction to the Rule, and Complying with FTC’s Health Breach Notification Rule (“Compliance Guidance”), a more in-depth compliance guidance.  These resources follow the FTC’s September 2021 Policy Statement, which expanded the Rule’s application to the developers of health apps, connected devices, and similar products, and similarly emphasize the FTC’s continued scrutiny of health technology.

Continue Reading FTC Releases New Health Breach Notification Rule Guidance, Targets Health Apps and Connected Devices

On Wednesday, October 6th, Governor Gavin Newsom signed SB 41, the Genetic Information Privacy Act, which expands genetic privacy protections for consumers in California, including those interacting with direct-to-consumer (“DTC”) genetic testing companies.  In a recent Covington Digital Health blog post, our colleagues discussed SB 41 and the growing patchwork of state genetic privacy