California Governor Gavin Newsom recently signed into law two bills that expand the delivery of telehealth services in the state. In particular, the legislation: Permits providers to prescribe medications without a synchronous interaction Requires payment parity of telehealth services under commercial plans Loosens restrictions on Medicaid coverage of store-and-forward services. California healthcare providers and commercial health payers should consider the following key takeaways from these laws. Remote Prescribing Assembly Bill No. 1264 (codified at Cal.…

A Collaborative Transformation Perspective on Digital Health Healthcare is facing an age of disruption from new players and new market entrants from outside the traditional healthcare paradigm. These disruptors have varying degrees of experience in the highly regulated and closely scrutinized healthcare landscape. How can these parties work together across different cultures and regulatory environments to fashion better, faster, more accessible healthcare? In this episode of the Of Digital Interest podcast, Stephen Bernstein and Kerrin Slattery discuss:…

A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National Coordinator for Health Information Technology’s (ONC’s) final rule, entitled 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, for review on October 28, 2019. Based on the rule title, it appears that ONC is…

The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several pre-existing medical device guidance documents. FDA also stated that it would continue to assess how to update and revise these…

The demand for healthcare innovation is driving collaboration between formerly disparate healthcare companies and bringing in new players, such as technology companies and start-ups, into an already complex space. As companies build partnerships and pool resources – particularly healthcare data – data ownership presents numerous challenges that need to be addressed throughout the lifecycle of the collaboration. In this episode of the Of Digital Interest podcast McDermott partners Jiayan Chen and Jennifer S. Geetter explore:…

In preparation for GDPR compliance, organizations around the globe worked months in advance of the deadline to ensure compliance. But what happened after the date of effectiveness? McDermott set out to learn how companies fared across the United States, Europe, China and Japan. In digging deeper, we discovered valuable findings, including: Countries and regions are at different points in their GDPR compliance awareness and execution journeys. Businesses across the globe continue to face challenges in…

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software applications and other transformative technologies, such as artificial intelligence and 3D printing, are reshaping how medical devices are developed, and FDA is seeking to align its mission and regulatory obligations with those changes. FDA’s digital health software precertification program is a…