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Medical Devices Mobile Apps Manufacturers

BakerHostetler

[Podcast] AD Nauseam: Left to Our Own Devices

BakerHostetler on

In this episode, hosts Amy Mudge and Daniel Kaufman discuss various health-related cases involving medical devices and FTC rulings. They delve into notable cases such as the QRay bracelet, which claimed pain relief through...more

Lippes Mathias LLP

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

Lippes Mathias LLP on

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

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

MoFo Life Sciences on

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more

Foley & Lardner LLP

OIG Greenlights Digital Health Program Offering Free Smartphones to Patients

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Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more

Holland & Knight LLP

OIG Approves Pharmaceutical Manufacturer’s Loaning of Smartphones to Support Digital Medicine (DM)

Holland & Knight LLP on

On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and...more

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