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Dale C. Van Demark advises clients in the health industry on strategic transactions and the evolution of health care delivery models. He has extensive experience in health system affiliations and joint venture transactions. Dale also provides counseling on the development of technology in health care delivery, with a particular emphasis on telemedicine. Dale has been at the forefront of advising clients with respect to the globalization of the US health care industry. He advises US and non-US enterprises with respect to the formation of cross-border affiliations and international patient programs. In addition to writing regularly on matters related to his practice, Dale has spoken at numerous conferences around the world on the globalization of health care. Read Dale Van Demark's full bio.

On March 4, 2020, the House passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, a bipartisan bill to aid in COVID-19 preparedness and response. The bill includes, among other things, provisions that waive certain telehealth requirements during the COVID-19 public health emergency to ensure Medicare beneficiaries can receive telehealth services at home

As the number of confirmed COVID-19 cases in the United States grows, healthcare providers are stepping up their response planning. To combat the spread of COVID-19, the Centers for Disease Control and Prevention (CDC) urged healthcare systems and providers to deploy all of the resources necessary to ensure health system preparedness. The CDC recommended the

When it comes to market success for digital tools in the health sector, business strategy can be far more complex than in other industries. Understanding customer-driven market trends is important, but healthcare’s complexity can camouflage customer demand and its regulatory ecosystem adds layers of additional considerations.

Customer Demand and Digital Solutions

The convenience, competitive pricing, answers-at-your-fingertips responsiveness and hyper-personalization delivered by top technology brands and their integration into other industry sectors has created an expectation for digital health solutions that deliver the same experience.

In some instances, consumers are finding the solutions. For example, telemedicine is gaining momentum as consumers discover that digital interactions with high-quality providers are oftentimes more convenient and less expensive than face-to-face encounters. Other tools are providing access to prescriptions, better health condition management solutions, better information sharing enabling smoother transitions among care settings, and more efficiency in everything from hospital operations to scheduling appointments to identifying in-network care options.

When it comes to business strategy, however, digital health solutions need to recognize that consumer pressures are frequently at odds with existing incentives within care delivery systems and, perhaps legal and regulatory requirements. Accordingly, it is critical not just from a compliance perspective but also from a business strategy perspective to navigate the healthcare industry’s unique market and regulatory dynamics.

Balancing Demand with Reality

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Certain long-standing laws, such as the civil monetary penalty provision prohibiting patient inducements, have hampered providers’ ability to fully leverage remote patient monitoring and other telehealth tools. Many stakeholders are hoping that developments in the Regulatory Sprint to Coordinated Care will begin the rulemaking process to enable greater access to digital health and virtual care

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.

  1. 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 product does not perform at the level described. As demonstrated in several recent public cases, an inaccurate statement of quality or efficacy can draw state and federal regulatory scrutiny, and carries consequences for selling your product in the marketplace and securing reimbursement.

Tech companies and non-traditional health industry players should take careful stock of the health sector’s unique requirements and liabilities in this area, as the risk is much higher in this arena than in other industries.


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As previously noted in our Digital Health Mid-Year Review, 2018 has seen greater acceptance of telemedicine within the Medicare program. Both regulatory and statutory changes have expanded reimbursement opportunities and, consequentially, opportunities for the deployment of telemedicine technologies. As we noted then, however, improvement in the Medicare reimbursement environment for telemedicine services has been

It has been only a little over six months, and already 2018 has been a busy year for digital health, particularly in the area of Medicare reimbursement. The Centers for Medicare and Medicaid Services (CMS), Congress, the Medicare Payment Advisory Commission, and the US Department of Health and Human Services (HHS) Office of Inspector General

Across the health care sector, telemedicine is naturally and strategically being integrated into health care delivery and treatment plans as targeted and efficient solutions to specific health issues by hospitals, medical groups and drug-to-consumer telemedicine companies.

Telemedicine is no longer viewed as a secondary option for care—it is a new standard of care that is

Join McDermott next Wednesday for a live webinar on the unique considerations in developing and procuring AI solutions for digital health applications from the perspective of various stakeholders. We will discuss the legal issues and strategies surrounding:

  • Research and data mapping essential to the development and validation of AI technologies
  • Protecting and maintaining intellectual property

Designed to provide business leaders and their key advisors with the knowledge and insight they need to grow and sustain successful digital health initiatives, we are pleased to present The Law of Digital Health, a new book edited and authored by McDermott’s team of distinguished digital health lawyers, and published by AHLA.

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