Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Get 'HIP'AA To Digital Medtech Law: More Than Just FDA To Worry About

Executive Summary

The digital medtech sector is growing fast. As new companies enter the space, they are going to face oversight from a slew of government agencies and statutes. While FDA is an important focus for medtech, patient privacy and cybersecurity challenges for digital products raise other, significant compliance challenges. Medtech Insight discussed the range of hurdles the digital medtech industry faces with attorneys from Akin Gump.

You may also be interested in...



2018 An Inflection Point For mHealth After An Active Year

The past year saw US FDA and industry work hard and fast to prepare for what looks like an inevitable boom in the digital-health sector. According to interviews, the time is ripe for adoption of mobile health apps to help reduce health-care costs, but the brave new world also brings with it big challenges.

Top US FDA Global Regulator Joins Major Law Firm's Health-Care Division

Howard Sklamberg, the former US FDA deputy commissioner for global regulatory operations and policy who left the agency in April, will now join the health-care practice at the law firm Akin Gump.

Software Fast Track? US FDA Asks Developers To Envision 'Precheck' Program

Developers of "software as a medical device" are unique to other device-makers in how fast their products are developed and updated. FDA digital health leader Bakul Patel is asking companies to provide input on the agency's idea for an expedited pathway for software that would be based on established trust.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT104640

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel