Innovative digital solutions intended to address health issues typically experienced by women have been an area of increased focus. Ranging from reproductive-related mobile applications to AI-enabled breast cancer screening devices, digital solutions for women+ health show promise to serve an enormous market with medical needs that have often failed to get the level of attention
FTC, HHS, and FDA Update Tool to Help Mobile Health App Developers Understand Legal Requirements
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
California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information
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.
California AG Probes for Potential Bias in Healthcare Algorithms, Federal Attention Continues
Digital health technologies, including algorithms for use in health care, are being developed to aid healthcare providers and serve patients, from use with administrative tasks and workflow to diagnostic and decision support. The use of artificial intelligence (“AI”) and machine learning algorithms in health care holds great promise, with the ability to help streamline care
OCR Seeks Comments Related to Recognized Security Practices and Distribution of Civil Monetary Penalties under the HITECH Act
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.
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FTC Releases New Health Breach Notification Rule Guidance, Targets Health Apps and Connected Devices
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.
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California Governor Signs Legislation to Expand Genetic Privacy Protections After Last Year’s Veto
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
Newly Effective Florida Law Imposing Criminal Sanctions Adds to Developing Nationwide Patchwork of State Genetic Privacy Laws
Last Friday, October 1, the Protecting DNA Privacy Act (HB 833), a new genetic privacy law, went into effect in the state of Florida establishing four new crimes related to the unlawful use of another person’s DNA. While the criminal penalties in HB 833 are notable, Florida is not alone in its focus
FTC Adopts Policy Statement on Privacy Breaches by Health Apps and Connected Devices
On September 15, the Federal Trade Commission (“FTC”) adopted, on a 3-2 party-line vote, a policy statement that takes a broad view of which health apps and connected devices are subject to the FTC’s Health Breach Notification Rule (the “Rule”) and what triggers the Rule’s notification requirement.
The Rule was promulgated in 2009 under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Under the Rule, vendors of personal health record that are not otherwise regulated under the Health Insurance Portability and Accountability Act (“HIPAA”) are required to notify individuals, the FTC, and, in some cases, the media following a breach involving unsecured identifiable health information. 16 C.F.R. §§ 318.3, 318.5. Third-party service providers also are required to notify covered vendors of any breach. 16 C.F.R. § 318.3.
Proposed Bill Would Expand the Scope of the CMIA
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.
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