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.

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 as best they can,” Klein, who focuses on privacy and data security matters, said. “I see a lot amazing technologies just from talking to clients that are going to be coming out and from my perspective it’s going to create a lot of really interesting data issues and a lot of interesting issues on the FDA side as well.”

Patient privacy and cybersecurity are two core challenges that raise special compliance challenges for digital medtech. Intellectual property enforcement is another area where digital health tools raise novel issues.

Nathan Brown, a partner at Akin Gump and former legal counsel at FDA, says what makes digital medtech products different is that they are not just medical products, but also software and services. He adds digital medtech products, by their nature, are on the nexus of multiple legal and compliance areas that could affect how they come to market.

“For a [digital] medtech product, it’s not as clear, whereas with a traditional FDA-regulated product they know at least that FDA is the primary source of regulatory oversight,” Brown said. “With something less traditional, it might be some combination of FDA, [Federal Trade Commission], [Federal Communications Commission].”

It is important for digital medtech to “take their FDA blinders off, because there’s more than one sheriff in town,” Klein said.