Health Tech Podcast - Episode 2: Best Practices for Health App Development
Background: The pandemic era ushered in exponential growth in the use of remote capabilities for all areas of life, with one of the most critical being the rise in telemedicine. Along with that expansion came an explosion in...more
The U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rule Making (Proposed Rule) on April 12, 2023, proposing amendments to the Health Insurance Portability and...more
The ripple effect from the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization has prompted the federal Office of Health and Human Services (HHS) to reinforce core principles of privacy compliance. HHS...more
A new Policy Statement from the US Federal Trade Commission places companies that offer consumer-facing health apps and connected health and wellness devices on notice that they may be covered by a Health Breach Notification...more
The Federal Trade Commission (“FTC”) recently issued an important policy statement to health apps and other connected devices that collect or use consumers’ health information. The FTC’s policy statement effectively...more
As the collection and use of health data drastically expands, the agency issued a recent guidance to officially put health apps and connected medical devices “on notice.” On September 15, the Federal Trade Commission...more
- Utah Pathology Services, based in Salt Lake City, has reported a data breach involving approximately 112,000 patients. According to the medical practice’s “Notice of Data Incident,” the practice learned June 30 that “an...more
A new bill introduced in the Senate Health, Education, Labor, and Pensions (HELP) Committee would impose federal regulatory obligations on health technology businesses that collect sensitive health information from their...more
Individuals who use healthcare apps such as fitness trackers, weight loss, wellness, exercise, etc., BEWARE! A couple of recent developments have highlighted the fact that most apps are not subject to HIPAA, which means that...more
The new Apple Watch Series 4® is one of the more recent and sophisticated consumer health engagement tools. It includes a sensor that lets wearers take an electrocardiogram (ECG) reading and detect irregular heart rhythms....more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney General's ("NY AG") March 23, 2017, announcement of settlements with three...more
The Department of Health and Human Services (HHS) will soon launch a healthcare focused cybersecurity initiative modeled on the Homeland Security Department’s National Cybersecurity and Communications Integration Center...more
The $2.5 million settlement reflects the agency’s focus on mobile health privacy. On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with CardioNet, a...more
Mobile health apps are becoming more and more popular as a tool for consumers in maintaining healthy lifestyles. However, there is a growing concern that the health-related benefits are being over-stated by mobile health app...more
The summer movie season is now officially in full swing, with the release of three informational videos regarding HIPAA and the right of individuals to access their medical records, published by the Office of Civil Rights of...more
This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more
The Federal Trade Commission (FTC), in partnership with other federal agencies, has released an online tool that provides developers legal guidance for the creation of mobile health applications (apps). Companies that are...more
OCR’s Compliance Guidance for Health Care App Developers - The U.S. Department of Health & Human Services’ Office for Civil Rights (OCR) recently provided guidance (in the form of six “real-life” scenarios) to help...more
Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of...more
OCR’s guidance presents hypothetical scenarios and key questions to help app developers determine when they are subject to HIPAA regulations. On February 11, the Department of Health and Human Services’ Office for Civil...more