1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Compliance

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

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.

Akin Gump attorneys Jo-Ellyn Sakowitz Klein and Nathan Brown discuss legal considerations digital medtech companies should consider as they work to bring products to market.
Jo-Ellyn Sakowitz Klein and Nathan Brown, attorneys at Akin Gump, discussed legal compliance challenges facing digital medtech firms. • Source: Ferdous Al-Faruque

Major growth is anticipated in the number of innovative digital medtech products, including consumer products and clinical-grade devices, developed in the coming years. This explosion is likely to create challenges for firms in various legal arenas, says Jo-Ellyn Sakowitz Klein, a senior counsel at Akin Gump Strauss Hauer & Feld.

"It's going to challenge innovators to try and do their best to keep on top of legal developments and comply...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Compliance

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.

Survey Reveals Gaps In Medtech Compliance Processes

 
• By Elizabeth Orr

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Global Medtech Guidance Tracker: July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

More from Policy & Regulation

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.

Brazil’s Medtechs Look To Solutions After 50% US Tariff Hit Amid ‘Scenario Of Uncertainty’

 
• By Bernard Murphy

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.

Survey Reveals Gaps In Medtech Compliance Processes

 
• By Elizabeth Orr

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.