Health Law Scan

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The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement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.

We invite you to join us in Houston on September 12 for our Second Cup of Coffee breakfast series covering the latest legal developments in digital health and healthcare innovation.

Could a new FDA regulatory approach for postmarket changes to artificial intelligence (AI)/machine learning (ML)–based software devices be in our future?

Did you catch our most recent edition of Fast Break? If not, we had an awesome extended session with Michele Buenafe on May 16 that was also part of our annual Technology May-rathon series.

We discussed a bit about the background of how a startup begins and explored the process through which a successful startup begins to obtain capital, especially when integrating vertically with potential buyers of their products (not just their business).