Health Tech Podcast - Episode 2: Best Practices for Health App Development
Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more
On September 29, 2024, California took a significant step forward in data privacy protection by passing a law that extends the California Consumer Privacy Act (CCPA) to cover neural data—brain activity and related information...more
Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...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
Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed...more
On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward...more
The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...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
Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is...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
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more
FDA announced last week that it has cleared for marketing an mHealth app that uses artificial intelligence (AI) to analyze CT images for signs of stroke. The app, called Contact, is a clinical decision support tool marketed...more
Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more
The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG...more
The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...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
The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD)....more
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more
On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the...more
Please join us for this complimentary CLE webinar. With increasing healthcare costs and the transition to value-based reimbursement, never has the need for connected medical devices been so great – and never have the...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
Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017....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
New York AG Settles Data Protection Enforcement Against Mobile Health Apps - After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone...more