On December 7, 2022, the Federal Trade Commission (“FTC”), along with the U.S. Department of Health and Human Services (“HHS”) and the U.S. Food and Drug Administration (“FDA”), announced updates to the Mobile Health App Interactive Tool—a questionnaire designed to help mobile health app developers identify federal laws and regulations that may apply to
Olivia Vega provides strategic advice to global companies on a broad range of privacy, health care, and technology issues, including in technology transactions, mergers and acquisitions, and regulatory compliance. Within her practice, Olivia counsels clients on navigating the complex web of federal and state privacy and data security laws and regulations, including on topics such as HIPAA, California’s Confidentiality of Medical Information Act, and the California Consumer Privacy Act. In addition, Olivia maintains an active pro bono practice.
On December 2, 2022, the U.S. Department of Health and Human Services (“HHS”), through the Office for Civil Rights (“OCR”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). Specifically…
On September 28, the governor of California signed into law AB 2089, which expands the scope of California’s Confidentiality of Medical Information Act (“CMIA”) to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services. …
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
Legislation that would amend California’s Confidentiality of Medical Information Act (“CMIA”) is working its way through California’s Senate and passed in the Senate Health Committee earlier this week. The proposed bill passed in the state’s Assembly back in April. Introduced by Democratic California Assemblymember Edwin Chau, who sits on the Privacy and Consumer Protection Committee, the proposed legislation (AB 1436) expands the definition of “provider of health care.” Under the CMIA, providers of health care are subject to various obligations, including provisions that restrict the disclosure of medical information without a prior valid authorization, subject to certain exceptions. …
Continue Reading Proposed Bill Would Expand the Scope of the CMIA
The Federal Trade Commission (“FTC”) announced this month a proposed settlement against Flo Health, Inc. (“Flo”), the developer of popular menstrual cycle and fertility-tracking application (the “Flo App”), resolving allegations that “the company shared the health information of users with outside data analytics providers after promising that such information would be kept private.” The proposed settlement requires Flo, among other things, to obtain review by an “independent third-party professional” of its privacy practices, obtain users’ consent before sharing their health information, alert users whose data was disclosed, and require third-parties that previously received that data to destroy it.
Continue Reading FTC Reaches Settlement with Digital Health App, Requires First Notice of Privacy Action
On January 14, 2021, the United States Court of Appeals for the Fifth Circuit vacated a $4.3 million civil monetary penalty that the Office for Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) imposed against the University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”). OCR ordered the penalty in 2017 following an investigation into three data breaches suffered by M.D. Anderson in 2012 and 2013, finding that M.D. Anderson had violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information and Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”). The Court, however, held that the penalty was “arbitrary, capricious, and otherwise unlawful,” in part based on its interpretation of the HIPAA Rules.
Continue Reading M.D. Anderson Wins Appeal Over $4.3 Million HIPAA Penalty
On January 5, 2021, an amendment to the Health Information Technology for Economic and Clinical Health (“HITECH”) Act was signed into law. The amendment requires the U.S. Department of Health and Human Services (“HHS”) to “consider certain recognized security practices of covered entities and business associates when making certain determinations” regarding fines, audit results, or other remedies for resolving potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). For organizations subject to HIPAA, the amendment provides substantial incentives to establish or improve their cybersecurity programs. While it does not establish a complete safe harbor from HIPAA enforcement, the amendment does offer organizations a chance to mitigate financial penalties and other negative regulatory actions that may result from a data breach.
Continue Reading HITECH Amendment Provides Some Protection For Covered Entities and Business Associates that Adopt Recognized Security Standards
On December 10, 2020, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule to modify the Standards for the Privacy of Individually Identifiable Health Information (the “Privacy Rule”) promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”). According to HHS’s announcement, the proposed rule would amend the Privacy Rule to “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.” Public comments on the proposed rule are currently being accepted through February 12, 2021.
The proposed rule is part of HHS’s Regulatory Sprint to Coordinated Care, initiated pursuant to Secretary Alex Azar’s value-based transformation agenda, which seeks to “promote value-based care by examining federal regulations that impede efforts among health care providers and health plans to better coordinate care for patients.” Throughout the Privacy Rule, HHS sought to protect health information while also permitting information sharing for certain beneficial purposes. However, stakeholders have questioned whether the Privacy Rule strikes the appropriate balance in certain situations.
Proposed modifications to the HIPAA Privacy Rule include strengthening individuals’ right to access their protected health information (“PHI”), including electronic PHI; facilitating greater family involvement in care for individuals dealing with health crises or emergencies; and allowing providers more flexibility to disclose PHI when harm to a patient is “serious and reasonably foreseeable,” such as during the opioid crisis or COVID-19 public health emergency. Importantly, multiple provisions of the proposed rule, discussed in greater detail below, address electronic health records (“EHRs”) and personal health applications.…