On February 14, 2024, Nebraska enacted a genetic privacy law (LB 308) regulating direct-to-consumer (“DTC”) genetic testing companies. The law is one of a flurry of bills regarding DTC genetic testing that have been introduced in several states since the beginning of 2024, following the enactment of several DTC genetic testing laws in 2023, such as in Virginia.Continue Reading Nebraska Enacts Direct-to-Consumer Genetic Privacy Law as Several Other States Propose Similar Bills at the Start of 2024
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 February 16, 2024, the U.S. Department of Health and Human Services (“HHS”) published a final rule to amend the Confidentiality of Substance Use Disorder (“SUD”) Patient Records regulations (“Part 2”) to more closely align Part 2 with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”)…
In a new post on the Covington Digital Health blog, our colleagues discuss recent amendments to California’s Confidentiality of Medical Information Act (“CMIA”) that (i) expand the scope of the law to cover reproductive or sexual reproductive or sexual health services that are delivered through digital health solutions and the associated health information generated from…
On Friday, the FTC announced that was entering a consent decree with 1Health.io Inc., which also does business as Vitagene, Inc. This is the fourth health-related FTC enforcement action announced this year (see here and here).
In addition, it comes on the heels of Virginia, Montana, and, as recently as last week, Texas joining California, Utah, and Arizona in adopting legislation specifically regulating the privacy practices of direct-to-consumer genetic testing companies. The recently adopted Montana law has a broader scope and narrower exceptions that raise questions about whether it will impede research, whereas the Texas law adopted last week is more similar to the other state models. Continue Reading FTC Enters Consent Decree with Direct-to-Consumer Genetic Testing Company On Heels of Other Significant Health and Genetic Privacy Developments
On May 18, 2023, the Federal Trade Commission (“FTC”) announced a notice of proposed rulemaking (the “proposed rule”) to “strengthen and modernize” the Health Breach Notification Rule (“HBNR”). The proposed rule builds on the FTC’s September 2021 “Statement of the Commission on Breaches by Health Apps and Other Connected Devices” (“Policy Statement”), which took a broad approach to when health apps and connected devices are covered by the HBNR and when there is a “breach” for purposes of the HBNR. The proposed rule primarily would (i) amend many definitions that are central to the scope of the HBNR (e.g., “breach of security,” “health care provider,” and “personal health record”), and (ii) authorize expanded means for providing notice to consumers of a breach and require additional notice content. According to the FTC, these changes to the HBNR would ensure the HBNR “remains relevant in the face of changing business practices and technological developments.” Below, we provide a brief summary of the history of the HBNR leading up to this proposed rule, a brief summary of the proposed rule, and a timeline for commenting.Continue Reading FTC Announces a Notice of Proposed Rulemaking to Expand Scope of the Health Breach Notification Rule
On May 17, the Federal Trade Commission (“FTC”) announced an enforcement action against Easy Healthcare Corporation (“Easy Healthcare”) alleging that it shared users’ sensitive personal information and health information with third parties contrary to its representations and without users’ affirmative express consent, in violation of Section 5 of the FTC Act. It also alleges that Easy Healthcare failed to notify consumers of these unauthorized disclosures, in violation of the Health Breach Notification Rule (“HBNR”). According to the proposed order, Easy Healthcare will pay a $100,000 civil penalty for violating the HBNR and, among other requirements, will be permanently prohibited from sharing users’ personal health data with third parties for advertising purposes. The FTC also noted that Easy Healthcare will pay a total of $100,000 to Connecticut, the District of Columbia, and Oregon for violating their laws.Continue Reading FTC Announces Second Enforcement Action Under Health Breach Notification Rule Against Fertility App Developer Easy Healthcare
On April 17, the Office for Civil Rights (“OCR”) at the U.S. Department of Health & Human Services (“HHS”) published a notice of proposed rulemaking that would revise the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule to bar certain uses and disclosures of protected health information (“PHI”) related to reproductive health care. Specifically, the proposed rule (“Rule”) would amend the Privacy Rule to prohibit covered entities or business associates (collectively, “regulated entities”) from using or disclosing PHI for purposes of (1) criminal, civil, or administrative investigations into or proceedings against any person in connection with seeking, obtaining, providing, or facilitating lawful reproductive health care, or (2) the identification of any person for the purpose of initiating such investigations or proceedings.
The Rule appears to be designed to further President Biden’s executive order directing HHS to consider actions that would “strengthen the protection of sensitive information related to reproductive healthcare services and bolster patient-provider confidentiality.” President Biden issued the order in the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.
Below, we provide a brief summary of the proposed changes and a timeline for commenting.Continue Reading HHS Issues Notice of Proposed Rulemaking on HIPAA and the Use and Disclosure of Information Related to Reproductive Health Care
On April 11, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that four Notifications of Enforcement Discretion (“Notifications”) that were issued under the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”) during the COVID-19 pandemic will expire on May 11, 2023. In response to the COVID-19 Public Health Emergency, OCR announced it would exercise enforcement discretion with respect to noncompliance with certain provisions of HIPAA. Now that the public health emergency is set to expire, OCR is rescinding the relevant Notifications. Below, we summarize the four Notifications that are set to expire:Continue Reading HHS Issues Notice of Expiration of COVID-19 HIPAA Enforcement Discretion
On March 26, 2023, Virginia enacted a genetic privacy law (SB 1087) aimed at regulating the practices of direct-to-consumer (“DTC”) genetic testing companies. Virginia is not the only state interested in regulating these companies—numerous other states, including Minnesota, Texas, Tennessee, and Vermont, have introduced similar bills during this legislative session, following the enactment of similar genetic privacy laws in Arizona, California, and Utah in recent years. Virginia’s SB 1087, effective July 1, 2023, adds to the growing net of state genetic privacy protections.Continue Reading Virginia Enacts Direct-to-Consumer Genetic Privacy Law as Numerous Other States Introduce Similar Bills
On December 20, 2022, the Federal Trade Commission (“FTC”) announced its issuance of Health Products Compliance Guidance, which updates and replaces its previous 1998 guidance, Dietary Supplements: An Advertising Guide for Industry. While the FTC notes that the basic content of the guide is largely left unchanged, this guidance expands the scope of the previous guidance beyond dietary supplements to broadly include claims made about all health-related products, such as foods, over-the-counter drugs, devices, health apps, and diagnostic tests. This updated guidance emphasizes “key compliance points” drawn from the numerous enforcement actions brought by the FTC since 1998, and discusses associated examples related to topics such as claim interpretation, substantiation, and other advertising issues.Continue Reading FTC Issues New Guidance Regarding Health Products