Emerging Companies

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

Digital Health

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

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

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

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

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:

  • Funding is Down Compared to Last Year’s First Quarter. While 2014 was a record-breaking year for digital health funding—increasing by more than double compared to 2013—both reports show that 2015 is off to a slower start. StartUp Health reported a decrease in overall venture funding in the digital health sector from $1.5 billion in the first quarter of 2014 to $900 million in the first quarter of 2015, while Rock Health, which uses different reporting metrics, reported a decrease from $700 million in the first quarter of 2014 to $630 million in the first quarter of 2015.

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), there have already been

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