Health Privacy

On September 15, the Federal Trade Commission (“FTC”) and U.S. Department of Health and Human Services (“HHS”) announced an updated joint publication describing the privacy and security laws and rules that impact consumer health data.  Specifically, the “Collecting, Using, or Sharing Consumer Health Information? Look to HIPAA, the FTC Act, and the Health Breach Notification Rule” guidance provides an overview of the Health Insurance Portability and Accountability Act, as amended, and the implementing regulations issued by HHS (collectively “HIPAA”); the FTC Act; and the FTC’s Health Breach Notification Rule (“HBNR”) and how they may apply to businesses.  This joint guidance follows a recent surge of FTC enforcement in the health privacy space.  We offer below a high-level summary of the requirements flagged by the guidance.Continue Reading FTC and HHS Announce Updated Health Privacy Publication

The Connecticut legislature passed Connecticut SB 3 on June 2, 2023.  If enacted by the governor, the bill would amend the Connecticut Data Privacy Act (“CTDPA”) to include a number of provisions related to health and minors’ data. Additional detail on the CTDPA can be found in our previous blog post here.

The health-related provisions would take effect on July 1, 2023.  Most provisions related to minors’ data would take effect on October 1, 2024.  However, requirements that social media platforms “unpublish” or delete certain minors’ accounts would come into effect on July 1, 2024.

As reflected in this bill, state legislatures appear increasingly focused on health privacy.  Connecticut’s bill comes on the heels of Nevada’s SB 370, which the Nevada legislature passed, and which, if enacted would impose requirements on consumer health data.  Both the Nevada and Connecticut bill resemble Washington’s My Health My Data Act, although they appear generally narrower in scope.  For additional detail on Washington’s My Health My Data Act, please review our blog post hereContinue Reading Connecticut Legislature Passes Amendments to the Connecticut Data Privacy Act

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

Washington’s My Health My Data Act (“HB 1155” or the “Act”), which would expand privacy protections for the health data of Washington consumers, recently passed the state Senate after advancing through the state House of Representatives.  Provided that the House approves the Senate’s amendments, the Act could head to the governor’s desk for signature in the coming days and become law.  The Act was introduced in response to the United States Supreme Court’s Dobbs decision overturning Roe v. Wade.   If enacted, the Act could dramatically affect how companies treat the health data of Washington residents. 

This blog post summarizes a few key takeaways in the statute.Continue Reading Washington’s My Health My Data Act Passes State Senate

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

In a new post on the Covington Digital Health blog, our colleagues discuss a recent amendment to California’s Confidentiality of Medical Information Act (“CMIA”) that expands the scope of the law to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services.  Continue Reading California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information