Digital Health

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The FTC recently announced that it had finalized the changes to the Health Breach Notification Rule (HBNR). This is roughly one year later from when the proposed changes were first released and three years later from the Agency’s initial “position statement” on the rule sparking controversy. The final changes clarify the scope of the rule to health apps and expands what must be told to consumers when notifying them of a breach. The updated rule goes into effect June 25, 2024.Continue Reading FTC Finalizes Breach Notification Rule Amendments Directed at Digital Health

The FTC and OCR at HHS are continuing to scrutinize the use of tracking technologies that may reveal information about a person’s health or health status. Both agencies recently sent a letter to a reported 130 hospitals and telehealth providers warning about the use of tracking technologies and the risks they pose. This follows on the heels of other statements, guidance, and enforcement actions from these regulators about these tools over the past two years.Continue Reading Regulators Send Warning Letter to Hospitals and Telehealth Providers About Tracking Technology Use

In this third post in our ongoing series, we examine the scope of the consent requirements under the recently enacted My Health My Data Act. (Visit here for information about the scope of the law and here for information about consumer rights). The Act imposes consent requirements on a wide range of common processing activities.Continue Reading My Health My Data Act: Consent Requirements

In this second post in our ongoing series, we examine the scope of rights given to consumers under the recently enacted My Health My Data Act. (Visit here for information on the scope of the law). The law provides consumers several rights, all of which are in other privacy laws. However, the requirements associated with some of these rights create some unique challenges.Continue Reading My Health My Data Act: Consumer Rights

On April 27, 2023, the state of Washington enacted a landmark privacy law aimed at protecting the privacy of health data not covered by HIPAA. While the 2023 legislative season has been busy for state “comprehensive” privacy laws, this law is likely to have the most impact on businesses. The My Health My Data Act covers a very wide range of entities, consumers, and data, as we describe below. And, it contains a private right of action. With the law coming into effect in the first half of 2024, organizations will want to take steps now to understand the scope of this law and its onerous obligations.Continue Reading My Health My Data Act: Scope of the Law

The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on companies that collect health information but may not be a covered entity or business associate under HIPAA. This includes publishing additional resources, releasing commentary broadly interpreting the FTC’s Health Breach Notification Rule, and enforcement activity. Most recently, the FTC and other key regulators updated its “Mobile Health App Interactive Tool”.Continue Reading FTC and Other Regulators Continue to Signal Interest in Mobile Health Apps

Utah recently joined California, Colorado, and Virginia in passing a comprehensive privacy law. It goes into effect December 31, 2023 and shares similarities with other states’ laws. Businesses may be glad to learn that Utah takes a lighter touch in some key areas.
Continue Reading The Beehive State Joins the State Privacy Law Hive: Utah Privacy Law Passes

The FTC recently published two new resources for complying with the Health Breach Notification Rule. The Rule requires vendors of personal health records (PHR), PHR-related entities and service providers to these entities, to notify consumers and the FTC (and, in some cases, the media) in the event of a breach of unsecured identifiable health information. The guidance reaffirms and adds further clarity to the Agency’s broad interpretation of the Rule released in its policy statement last fall.
Continue Reading FTC Continues to Signal Interest in Digital Health Industry, Publishing Updated Resources

The digital health sector has been rapidly growing, and the demand is not expected to diminish. Those in the industry will want to keep in mind some key legal concerns in the coming year, which we outline in this recent article. Privacy and cybersecurity features among these, and include more than just HIPAA concerns. There is an ever-growing patchwork of state and federal privacy laws that are being applied to the industry. At the same time, cyber threat actors are finding ways to attack even the most prepared companies in the digital health space.
Continue Reading Digital Health Trends and Privacy: What to Watch in 2022