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Software as a Medical Device (SaMD): Health Care Regulatory Considerations

Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more

‘Move fast and break things’ is a bad idea for health tech startups

It may seem counterintuitive, but one of the reasons some entrepreneurs are drawn to healthcare are the regulations. No industry outside of defense is as heavily scrutinized, and for good reason: When you deal with people...more

COVID-19: Provider Relief Funds for Assisted Living Facilities

On September 1, 2020, the U.S. Department of Health and Human Services (HHS) announced that assisted living facilities (ALFs) may now apply for funding under the Provider Relief Fund (PRF) Phase 2 General Distribution...more

COVID-19: Free Lodging, Free Testing, Free of OIG Enforcement?

Not necessarily. In the past two weeks, the Office of Inspector General (OIG), the Department of Health and Human Services (HHS) watchdog, released two new FAQs regarding the Application of OIG’s Administrative Enforcement...more

COVID-19: Notable Impacts for Post-Acute Providers from the CARES Act, CMS Blanket Waivers, and the CMS Interim Final Rule

Between various blanket Section 1135 waivers and state specific waivers issued by CMS, provisions of the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) and numerous state, local and accreditation body...more

COVID-19: Telehealth Takeaways from the CARES Act

On March 27th, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). On both the federal and state levels we have seen efforts to support social distancing in the...more

COVID-19: Washington Becomes the Second State Approved For 1135 Medicaid Waiver – Key Takeaway

On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more

Florida Issues New Emergency Order Further Relaxing Licensure, Telehealth, and Practice Standards to Combat COVID-19

To further relax strict compliance with certain health care practice statutes and rules that could prevent, hinder, or delay necessary action relating to the Coronavirus (COVID-19) outbreak, Florida Surgeon General, Scott...more

COVID-19: Washington Becomes the Second State Approved For 1135 Medicaid Waiver – Key Takeaways

On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more

Managing the Commercial Impact of Coronavirus: Emergency Order Relaxes Florida Licensure, Telehealth, and Practice Standards to...

As part of Florida’s response to the rapidly developing novel coronavirus (COVID-19) pandemic, the Florida Surgeon General, Scott Rivkees, M.D., of the Florida Department of Health (DOH), issued Emergency Order 20-002 (Order)...more

COVID-19: CMS Issues EMTALA Guidance

As the coronavirus pandemic has unfolded, hospitals across the country have begun asking how the Emergency Medical Treatment and Labor Act (EMTALA) will be applied to them when they are confronted with individuals coming to...more

COVID-19: States Waive In-State Licensing Requirements for Health Care Providers

Over the last week, the number of COVID-19 cases in the United States has spread to nearly all 50 states, with the number of confirmed cases changing by the minute. Federal, state, and local officials are evaluating options...more

Telehealth: 5 Key Takeaways from the Coronavirus Spending Bill

The recent coronavirus outbreak is gaining world attention as it spreads, with increasing focus on outbreaks and containment efforts throughout the United States. On March 6, 2020, President Trump signed into law an emergency...more

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