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:
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
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
Continue Reading ONC Report to Congress Identifies Gaps in Oversight of Privacy and Security of mHealth Technologies and Health Social Media
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
Continue Reading Multistakeholder Group Seeks Comment on Draft Framework for IoT Device Manufactures
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:
Continue Reading Digital Health Venture Funding, M&A and IPO Activity in the First Half of 2015
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 Federal Court Enjoins Texas’ Restrictions on Telemedicine
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 Teladoc Embarks on Road to an IPO
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:
Continue Reading Digital Health Venture Funding and M&A Activity in the First Quarter of 2015
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
Continue Reading FDA Regulation of mHealth Updates
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
Continue Reading The Cyber Future of Long-Term Care: Applying Health Care Laws to Aging in Place Technologies