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Florida’s Extension of its COVID-19 Out-of-State Provider Waiver: A Sign of the Times

Background: Issuing Florida's Emergency Order On March 16, 2020, Florida Surgeon General Dr. Scott Rivkees signed, stamped and finalized Emergency Order 20-002. In doing so, Florida joined what would become the vast majority of states in modifying licensure requirements for physicians in response to the Coronavirus (COVID-19) emergency. The surgeon general’s order waived licensing requirements for out-of-state healthcare professionals, advanced life support professionals and basic life support professionals so that they could render services in Florida for the purposes of preparing for, responding to and mitigating any effect of COVID-19. In addition to waiving licensing requirements for in-person services, the order exempted out-of-state physicians, osteopathic physicians, physician assistants and advanced practice registered nurses from licensing requirements governing the provision of telehealth. The order also impacted emergency medical services training...

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Telemedicine Collaborations and Partnerships: Key Considerations for Success

Telemedicine collaborations, whether between technology companies and providers, health systems and patients, or other creative partnerships we have yet to see in the industry, can present numerous benefits to our healthcare delivery system and patient outcomes. However, such collaborations present a variety of regulatory, logistical and operational concerns that should be strategically addressed from the ideation stage of the collaboration onward. Early-Stage Considerations The strategy behind the collaboration should be developed with an eye towards the duration of the relationship and the development of mutually beneficial goals and objectives that are clear and measurable. Each party should be transparent about their capabilities and strategic vision at the outset of the collaboration talks to avoid any surprises or disappointments deeper in the future. Questions for potential collaboration partners include: Is this an experimental partnership or a...

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Three Tips for Tackling Risk in Digital Health

Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but in some cases from their own investors. While the regulatory framework for digital technology in health care and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success. Be accurate about quality. Ensuring that you have a high-quality product or service is only the first step; you should also be exactingly accurate in the way that you speak about your product’s quality or efficacy. Even if a product or service does not require US Food and Drug Administration clearance for making claims, you still may face substantial regulatory risk and liability if the...

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Digital Health in the UK: The New Regulatory Environment Under the Medical Device Regulation

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long Term Plan, which set out ambitious aims for the acceleration and adoption of digital health and AI, particularly in primary care, outpatients and wearable devices. Although these developments are encouraging to developers, there is still no clear framework for reimbursement or tariffs for digital health tools and AI. At the same time, the plethora of new technologies has led to increased calls for regulation and oversight, particularly around data quality and evaluation. Many of these concerns may be addressed by the new Medical Device Regulation (MDR) and other regulatory developments. In fact, there is some risk that while regulatory landscape is moving quickly, the pricing environment is still a...

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Breaking into Digital Health: Factors Companies Must Consider

Companies looking to enter the digital health field face myriad legal implications unique to doing business in this sector. Whether emerging or established, companies exploring health care opportunities benefit from careful planning around complex issues such as pace of development, reimbursement systems, strategies for responsible data collection and use, and effective corporate compliance programs. In this podcast, McDermott partners Sarah Hogan, Lisa Schmitz Mazur and Dale Van Demark take a closer look at these and other important factors companies should review when contemplating a move into the digital health ecosystem. Q. What issues should companies consider before they enter today’s digital health care market? DV: The first and perhaps most important thing to focus on is the business plan. A lot of business plans that may work in other service sectors may not work in the health care industry because of the way that it is structured or because of...

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Maximizing the Value of Big Data in Digital Health

The interest in leveraging the value of big data in digital health has become a focus of health care industry mainstays and newcomers alike. Within a challenging regulatory landscape, it is critical for those looking to play in this space to be proactive in planning their data strategy, with an eye towards compliance planning and solid due diligence to maximize its value. In this Q&A, big data thought leaders Bernadette Broccolo and Sarah Hogan, both partners in McDermott Will & Emery's Health Industry Advisory group, discuss the challenges and opportunities that health industry stakeholders face when stepping into the world of big data. For information on this topic and to hear the full Q&A with Bernadette and Sarah, listen to the newest episode of the Of Digital Interest podcast. You can access the full episode at here or subscribe to the podcast on iTunes, Pocket Casts or Soundcloud. Q. Where is the value in big data in digital health? Who is...

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