On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar: Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company … Continue Reading
In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Commercial Questions When Contracting for Digital … Continue Reading
Earlier this month the U.S. Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), released a report to Congress highlighting “large gaps” in policies and oversight surrounding access to and security and privacy of health information held by certain “mHealth technologies” and “health social media.” mHealth technologies … Continue Reading
Last week, our colleague Libbie Cantor published a post on our InsidePrivacy blog regarding the Online Trust Alliance’s (OTA) release of a draft framework of best practices for Internet of Things device manufacturers and developers. This draft framework applies to, among other things, eHealth technology, such as wearable fitness and health technologies. The OTA is seeking comments on … Continue Reading
StartUp Health, a New York-based accelerator, and Rock Health, a San Francisco-based seed fund, each recently released its independent 2015 mid-year report on venture funding and transactional data of the digital health sector. The following are some key observations: Funding Levels Are Keeping Up With the Record-Breaking Levels in 2014. While this year was off … Continue Reading
Late last month, a federal district court in Texas enjoined the Texas Medical Board from implementing a rule that would have significantly curbed the use of telemedicine in the state. The decision is a major victory for telehealth proponents in Texas.… Continue Reading
Teladoc, Inc. started the long road to an IPO yesterday, announcing that it had taken the first step in the process by submitting an S-1 registration statement — the very detailed disclosure document required by regulators — with the U.S. Securities and Exchange Commission.… Continue Reading
StartUp Health, a New York-based accelerator, and Rock Health, a San Francisco-based seed fund, each recently released its independent 2015 first quarter report on venture funding and transactional data of the digital health sector. The following are some key observations: Funding is Down Compared to Last Year’s First Quarter. While 2014 was a record-breaking year … Continue Reading
At the Food Drug and Law Institute’s annual conference on April 21, 2015, Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center for Devices and Radiological Health (CDRH), held a discussion of “FDA Regulation of Mobile Health/Medical Applications.” As we discussed in a previous post (see here), there have already been several … Continue Reading
Earlier this month, the National Law Journal published its annual Special Report on Health Care Law. Included in this Special Report is an article written by CovingtonEHealth contributors Caroline Brown, Anna Kraus, and Phil Peisch, entitled, The Cyber Future of Long-Term Care: Applying Health Care Laws to Aging in Place Technologies. This article explores how … Continue Reading
The excitement around eHealth innovations was palpable throughout San Francisco this week as the annual JP Morgan healthcare conference flooded the city. JP Morgan itself offered panels and presentations from industry leaders and emerging companies, while simultaneously occurring conferences, speaker programs, and networking events throughout San Francisco featured discussions on the changing face of healthcare … Continue Reading
