Software, Mobile Health Apps

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

Lippes Mathias LLP on 8/23/2021

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

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 2 Of 6)

MoFo Life Sciences on 2/19/2021

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

Building a Health App? Part 2: Protecting Your Intellectual Property

Mintz - Health Care Viewpoints on 9/25/2017

This post is the second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful...more

Building a Health App? What You Need to Know

Mintz - Health Care Viewpoints on 9/18/2017

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

[Webinar] Medical Device Connectivity: HIPAA, FDA and IP Considerations - June 14th, 2pm ET

BakerHostetler on 5/31/2017

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

New EU Rules for Medical Devices

Sheppard Mullin Richter & Hampton LLP on 7/13/2016

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more