Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health.
Health Law Scan
Legal Insights and Perspectives for the Healthcare Industry
Telehealth is a highly regulated field and legal issues can vary across payers, across states, and even across countries. Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic. In China, the Chinese government has been actively promoting internet-based medicine, even before the COVID-19 pandemic accelerated the need for telehealth services.
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.
As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the coronavirus (COVID-19) crisis.
Healthcare industry lawyers Eric Knickrehm and Jake Harper recently authored a LawFlash analyzing medical licensure waivers issued in connection with the coronavirus (COVID-19) emergency that permit healthcare professionals to receive federal healthcare program reimbursement for telehealth services in states where they do not hold a license.
CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the coronavirus (COVID-19) crisis.
As part of emergency funding to combat the threat of the 2019 Novel Coronavirus (COVID-19), last week Congress waived many of the telehealth restrictions for Medicare services in certain situations. This monumental change could—depending on how it is implemented—radically alter how telehealth is performed in connection with the government’s most ubiquitous healthcare program.
Partner Reece Hirsch recently attended and spoke at the 2020 Health Datapalooza held in Washington, DC.
Several lawyers from our healthcare industry team recently attended HLTH in Las Vegas. HLTH provided a showcase for innovative ideas, platforms, and programs embracing the concept of “patient-centered care.”
The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software.