Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “Dexcom App Outage Highlights Communication Pitfalls for Device Makers,” by Maria Rachal.
Following is an excerpt:
A week after a service outage left many diabetes patients’ caretakers unable to remotely track blood sugar readings via a popular Dexcom app, questions remain regarding what precisely led to the tech breakdown.
Broad dissatisfaction with the company’s response, however, was clear. Reactions to the service disruption on social media served as a reminder of just how integral remote monitoring has become to many people’s diabetes management in recent years.
The issue was not that Dexcom’s main continuous glucose monitor product stopped working for the primary user, but that a key benefit offered with the system — a service that enables data streaming and alerts to parents, spouses or other caregivers’ smartphones — went down the weekend following Thanksgiving and was not entirely resolved until the middle of last week. …
The outage also raised questions about whether a third-party like FDA needs to more stringently review pre-developed crisis communications plans in the event of malfunctions to mobile apps involved in delivering a potentially critical healthcare service.
Many of those considerations ought to already be baked into the risk mitigation plans currently required by FDA, said Epstein Becker Green attorney Bradley Merrill Thompson. ”I don’t know what happened with Dexcom, but I do know the agency is very demanding,” he said.