On February 1, 2023, the FTC announced a proposed $1.5 million settlement with GoodRx Holdings, based on alleged violations of the Federal Trade Commission Act (“FTC Act”) and Health Breach Notification Rule (“HBNR”) for using advertising technologies on its websites and mobile app that resulted in the unauthorized disclosure of consumers’ personal and health information to advertisers and other third parties. On the same day, the U.S. Department of Justice, acting on behalf of the FTC, filed a Complaint and Proposed Stipulated Order detailing the FTC’s allegations and the terms of the proposed settlement. 

Continue Reading FTC Brings Enforcement Action Under FTC Act and Health Breach Notification Rule Based on GoodRx’s Use of Advertising Tracking Technology on Its Websites and Mobile Application

On December 1, 2022, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a bulletin warning that commonly used website technologies, including cookies, pixels, and session replay, may result in the impermissible disclosure of Protected Health Information (“PHI”) to third parties in violation of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The bulletin advises that “[r]egulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of Protected Health Information (“PHI”) to tracking technology vendors or any other violations of the HIPAA Rules.” The bulletin is issued amidst a wider national and international privacy landscape that is increasingly focused on regulating the collection and use of personal information through web-based technologies and software that may not be readily apparent to the user.

Continue Reading HHS Warns HIPAA Covered Entities and Business Associates That Use of Website Cookies, Pixels, and Other Tracking Technology May Violate HIPAA Rules

The U.S. Supreme Court is expected to imminently issue its opinion in the case Dobbs v. Jackson Women’s Health Organization (“Dobbs”). If the Court rules in a manner to overturn Roe v. Wade, states will have discretion in determining how to regulate abortion services.[1] Such a ruling would overturn nearly 50 years of precedent, leaving patients, reproductive health providers, health plans, pharmacies, and may other stakeholders to navigate a host of uncharted legal issues. Specifically, stakeholders will likely need to untangle the web of cross-state legal issues that may emerge.

Continue Reading The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe

The past several years have proven difficult for healthcare entities due to increasing cybersecurity threats, breaches and regulatory enforcement. Following these trends, on April 6, 2022, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a Request for Information (RFI) soliciting public comment on how regulated entities are voluntarily implementing security practices under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) and also seeking public input on sharing funds collected through enforcement with individuals who are harmed by Health Insurance Portability and Accountability Act of 1996 (HIPAA) rule violations.

Continue Reading HIPAA Enforcers Seek Public Input on Recognized Security Practices and Sharing Enforcement Recoveries with Affected Individuals

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently submitted two reports to Congress setting forth the HIPAA breaches and complaints reported to OCR during calendar year 2020 as well as the enforcement actions taken by OCR in response to those reports. HIPAA covered entities should be aware of the trends identified in these reports and should examine their own compliance in these areas.

Continue Reading HHS OCR Issues Annual HIPAA Reports to Congress

On March 15, 2022, President Biden signed into law the 2022 Consolidated Appropriations Act containing the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (the “Cyber Incident Reporting Act”). While President Biden’s remarks highlighted the $13.6 billion in funding “to address Russia’s invasion of Ukraine and the impact on surrounding countries,” the 2022 Consolidated Appropriations Act contained numerous other laws, including the Cyber Incident Reporting Act, which should not be overlooked. The Cyber Incident Reporting Act puts in motion important new cybersecurity reporting requirements that will likely apply to businesses in almost every major sector of the economy, including health care, financial services, energy, transportation and commercial facilities. Critical infrastructure entities should monitor the upcoming rule-making by the Cybersecurity and Infrastructure Security Agency (“CISA”), as the final regulations will clarify the scope and application of the new law.

Continue Reading President Biden Signs into Law the Cyber Incident Reporting Act, Imposing Reporting Requirements for Cyber Incidents and Ransomware Payments

The Federal Trade Commission (“FTC”) recently issued guidance clarifying protections applicable to consumers’ sensitive personal data increasingly collected by so-called “health apps.” The FTC press release indicated it has approved a policy statement by a vote of 3-2 offering guidance that organizations using “health applications and connected devices” to “collect or use” consumers’ personal health

On Tuesday, August 24, 2021, California Attorney General Rob Bonta issued a guidance bulletin (the “Guidance”) to health care providers reminding them of their compliance obligations under California’s health data privacy laws, and urging providers to take proactive steps to protect against cybersecurity threats. This Guidance comes, in part, as a response to federal regulators