Health Tech Podcast - Episode 2: Best Practices for Health App Development
Section 1557 of the Affordable Care Act (ACA) prohibits providers and health plans that receive reimbursement from the federal government from discriminating against individuals in the Covered Entities’ health programs. Such...more
As we previously reported, the Federal Trade Commission (FTC) recently announced its final changes to the Health Breach Notification Rule (HBNR), vastly expanding the scope of the Rule’s coverage....more
The Federal Trade Commission’s (FTC) years-long effort to modernize its Health Breach Notification Rule (HBNR) in the midst of a swiftly changing technological landscape appears to be coming to an end. On Thursday, May 30,...more
In part one of our series "FemTech: how this growing industry can build trust, protect privacy and redress healthcare inequity… one app at a time", we take an introductory look at the industry, and offer some...more
Appropriately so, providers look first to the Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA), to ensure that they comply with regulations regarding patients’ protected health information...more
On May 18, the Federal Trade Commission (FTC) proposed changes to the Health Breach Notification Rule (the HBNR or the Rule), including clarifying the rule’s applicability to health apps and other similar technologies. These...more
On May 17, 2023, the Federal Trade Commission (the “FTC”) reached a settlement with Easy Healthcare Corporation (“Easy Healthcare”), for its fertility-tracking app, Premom. The agency alleged that Easy Healthcare failed to...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 Health Insurance Portability and Accountability Act of 1996 may be the most well-known privacy law in the United States, but it is also one of the most misunderstood....more
As we start 2022, as part of our Spotlight series, we connect with Reece Hirsch, the co-head of Morgan Lewis’s privacy and cybersecurity practice, to discuss the recent policy statement issued by the US Federal Trade...more
In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors...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
- 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
On November 7, the U.S. Food and Drug Administration (FDA) announced the launch of the MyStudies app, the latest in a series of concrete activities to drive the integration of the patient voice in clinical trials and the drug...more
According to an Apple press release, iPhone users will now be able to store and view their medical records on their phones as part of a new feature found in iOS 11.3. Although many patients are already familiar with...more
The use of new technologies such as digital health applications, telemedicine, and information exchanges can provide game-changing benefits for providers and patients alike. However, with increased sharing comes increased...more
What if you didn’t have to take time out of your day to see a physician in person when you needed a prescription? What if a diagnosis could be delivered over video chat? What if your psychiatrist was available at the press of...more
This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...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
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
That electronic device in your palm has become more than your best friend. Half the adults around the world have become so addicted to their smart phones that wags say we are a new species: Phono sapiens. Can our phones...more
Ian O’Neill, a shareholder in the firm’s Intellectual Property Department focusing on technology transactions, licensing, advanced media and privacy issues, and Emily Weber, a shareholder in the firm’s Health Care Group...more
With expenditures of over $ 3 trillion of market in the field of health care in the United States is huge. Incentives of the Federal Government for the introduction of electronic medical records resulted increasingly in the...more
As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more
Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient’s activity tracker—in this case, a Fitbit® —are able to pinpoint when the patient’s normal...more