Hogan Lovells’ Medical Device & Technology practice reflects on its COVID-19 work and looks ahead to what may come next

In just a few short months, the team has taken on almost 200 matters, ranging from attaining Emergency Use Authorizations (“EUAs”) for critical medical devices and testing kits from the U.S. Food and Drug Administration, to advising on legal risks for producing various types of PPE, to importing devices such as ventilators from China for use in the U.S. and around the world.

As the world continues to feel the economic and public health ramifications of the virus, the team has taken a look at a few key areas the pandemic has influenced to think about what the next few months may bring and what may never look the same again.

Telehealth

“Telehealth and remote patient monitoring are here to stay now that COVID-19 has forced us to prove that the technology works and patients can make the technology work for them,” said partner Jodi Scott. “There are many patients who will be grateful for the efficiencies it will bring to their lives. Certainly, there are still some things that will require a trip to the office, but there are many that can be handled over a videoconference. With FDA’s increasing flexibility and comfort with the technology, developers should feel emboldened to be creative.”

Counsel Brooke Bumpers echoed that many of her clients shared that sentiment, adding that “both providers and patients have been very pleasantly surprised at how well it is working, and it is hard to imagine a complete return to the status quo. I’ve spoken with clients who are health care providers who acknowledge that though they had long resisted using telehealth, they can’t believe how much they like it and how well it works even for patient populations for whom they didn’t think it would be a good fit.”

Counsel Kristin Zielinski Duggan also noted that regulatory and practical acceptance of alternative healthcare delivery strategies may keep more patients out of hospitals by allowing certain procedures to be carried out in their doctors’ office instead. “Companies are getting really creative in this way – and FDA is being flexible as well,” she said. “We have been lucky to be able to assist clients with getting these solutions implemented, whether it be through expedited 510(k) notices or enforcement discretion, for products that do not fall under traditional EUAs.”

Importing medical devices from China and other countries

The regulatory environment to import approved and non-approved medical devices has always been difficult. But through our work with clients during the COVID-19 crisis, we have helped speed up that process while ensuring safety standards are retained.

Partner Fabien Roy said “we have helped multiple clients to understand the European marking requirements applicable to face masks such as FFP2 masks and surgical masks. Through our investigations, more EU Member States introduced derogation procedures to ensure quicker access to the market for manufacturers.”

Importing products to the U.S. has proven equally challenging because of the strict requirements from the FDA and the sheer logistical complexity involved to move the products across borders, according to Jodi Scott. “The FDA has been incredibly flexible, accommodating, and proactive in its efforts to make imports possible to increase the availability of supplies through the issuance of enforcement policies and emergency use authorizations,” she said. “As long as we are in the public health emergency, the challenges related to securing necessary supplies like PPE, ventilators, and respirators will continue, and will continue to evolve.”

Partner Mike Heyl added that “it has been truly inspiring and amazing to see the ingenuity and ambition of our clients to work so hard to help health care providers and the public at-large during the pandemic.”

“But while our efforts to assist clients bringing in PPE and other needed devices that meet FDA and other US government standards continue, we also are addressing long-term opportunities, such as seeking marketing authorizations and analyzing supply chain vulnerabilities that will benefit the post-pandemic marketplace,” Heyl said.

Reporting test results

“Required reporting of test results has been a key feature of the government’s COVID-19 response that facilitated mapping the virus, both in terms of spread and for identification of hot spots,” said senior associate Blake Wilson. "However, as we seek to expand testing beyond “traditional” health care and laboratory settings and into point-of-care use (e.g., the work place, public gatherings, etc.), compliance with these reporting requirements will become more challenging.”

Senior Director Susan Tiedy-Stevenson also noted that “organizations using these tests in these expanded environments may need to be creative as to how health care professionals can be involved in the assessment of results, and how they can ensure that accurate reporting to types of settings, such as through telemedicine, can be achieved.”

"Organizations implementing a COVID-19 screening process need to be proactive in assessing the different reporting obligations that may be in play, both at the federal and state level,” said Wilson. “Such conversations should involve relevant stakeholders and need to include a clear understanding of what the reporting obligations are and who will make the report, as well as how this information should be disclosed to the patient.”

What comes next?

“The medical risks and overarching impact the pandemic has had on public health is unprecedented,” said Randy Prebula, the leader of the Medical Device & Technology practice. “Stakeholders from throughout the product life cycle, from suppliers through providers and regulatory bodies have been exceedingly creative and flexible. That flexibility and creativity will also be essential in helping transition to a new normal as risk levels change.”

Jonathan Kahan, a partner in the practice, added that “the pandemic has changed how medical technology companies, health care providers, and patients approach health care. The movement to telehealth, remote monitoring, and the growing reliance on artificial intelligence has been accelerated by the pandemic, and that trend is not likely to end as the pandemic subsides.”