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Digital Health 2021 Year in Review

The continuation of the COVID-19 public health emergency (PHE) and consumer demand for digitally delivered healthcare not only necessitated the shift from in-person to virtual care, but also continued to drive interest, adoption, investment and transactions in digital health in 2021. Digital health funding in 2021 far surpassed 2020’s totals, with no signs of slowing down in 2022, and the potential permanence of some regulatory flexibilities beyond the PHE are charting a course for continued digital health growth in 2022 and beyond.

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2022 Health Policy Outlook

The US healthcare system is entering the third year of a public health emergency due to COVID-19, and the challenges and enduring pressures of the pandemic will require US Congress and the Biden administration to consider new response strategies. But other health policy priorities also will garner attention. As we start a new year and new congressional session, McDermott+Consulting examines the health policy priorities and key initiatives likely to dominate the agenda in 2022.

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VIDEO: Telehealth Laws in Flux as Pandemic Precautions End

The uncertainty around the termination of state public health emergencies is leading to the growth of healthcare companies with physical and virtual presences. In this recent Reuters video, McDermott Partner Lisa Mazur explained how these providers are more valuable from a valuation perspective.

“And part of that is because they’re able to enroll in Medicaid and get services covered, and they’re more likely to become a participating provider with a commercial plan,” Mazur noted.

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Broadband Internet a Hurdle as Telehealth Services Rise in Popularity

Doctors and lawmakers say reliable broadband internet is lagging for populations that could benefit the most from telehealth services. In this MetroWest Daily News article, McDermott Partner Stephen Bernstein and McDermott+Consulting Vice President Mara McDermott offer insight into the challenges—and opportunities—for virtual care as it gains popularity.

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The “New” Digital Healthcare Delivery System

Although digital health solutions have long been a key area of strategic growth for the healthcare industry, the COVID-19 crisis accelerated what it means to deliver safe and effective digitally-based care. As the United States shifts focus from short-term crisis response to longer-term solutions, what does a digitally-driven healthcare industry look like, and how can healthcare entities maintain the highest standards of care and meet patient expectations while constructively disrupting out-of-date practice patterns? During a recent virtual conversation, McDermott Partners Michael W. Ryan and Jennifer S. Geetter addressed these questions and more.

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Artificial Intelligence Myth Versus Reality: Where Do Healthcare Experts Think We Stand?

As the healthcare industry evaluates how to pay for artificial intelligence (AI) solutions, industry experts say data and real-world evidence are essential for reaching any payment decisions. In this Forbes article, McDermott Partners Dale C. Van Demark and Jiayan Chen provide insight into some of the regulatory challenges AI presents.

“For AI to be paid for, you need data that shows your product is making a difference,” Chen notes. “To do that, you need massive quantities of data to develop the tool or algorithm, but you also have to show that it works in a real-world setting.”

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FTC Issues Policy Statement Expanding Interpretation of Health Breach Notification Rule’s Scope

On September 15, 2021, the Federal Trade Commission (FTC) voted 3–2 along party lines (with Republican commissioners dissenting) to issue a policy statement announcing an expansive interpretation of the FTC’s Health Breach Notification Rule, 16 CFR Part 318 (the Rule). According to the policy statement, the Rule applies to health apps and connected devices that are not subject to the Health Insurance Portability and Accountability Act (HIPAA) but are capable of drawing information from multiple sources—for example, through a combination of consumer inputs and application programming interfaces (APIs).

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50-State Survey | Rules Governing Telehealth Modalities and Patient-Provider Relationships

Telehealth’s state-by-state regulatory patchwork means that healthcare providers must navigate a variety of regulations that govern which types of care can be provided by virtual means, and even what modalities can be used in different care settings. McDermott’s recent 50-state survey explores the standard and requirements that physicians and nurse practitioners must follow when prescribing non-controlled substances or ordering tests via a telemedicine encounter. Key issues addressed in the survey include:

  • In what states are asynchronous solutions permitted?
  • What are state rules governing prescriptions when a physician-patient relationship does not exist prior to the telehealth encounter?
  • What are state rules on prescribing via audio-visual encounters or audio-only encounters?
  • Under what state regulations can a questionnaire be sufficient to create a physician-patient or advance practice registered nurse-patient relationship?

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Protecting the Telehealth Consumer: FTC and State-Based Considerations

Telemedicine in the United States is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers instituted during the COVID-19 pandemic are likely to expire soon. As lawmakers and agency officials consider updated or expanded digital health rules, regulators are expected to intensify their scrutiny of providers.

In this webinar, McDermott partners Jiayan Chen and Brian J. Boyle explore consumer protections for telehealth consumers, including the following:

  • Privacy considerations beyond the Health Insurance Portability and Accountability Act of 1996, including Federal Trade Commission requirements;
  • How to prepare for the Health Breach Notification Rule;
  • The ins and outs of advertising telehealth, including claims, endorsements and social media;
  • Strategies for engaging with users in the digital environment; and
  • Increased fraud enforcement.

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Access to Digital Health Applications and Digital Care Applications in Germany

The German federal cabinet recently approved the draft law on the digital modernization of healthcare and nursing care. The draft has been criticized for not taking into account lessons learned from the implementation of the 2019 digital health applications (DiGAs) law.

In this International News article, McDermott Will & Emery partner Dr. Stephan Rau and McDermott alumna Dr. Karolin Hiller provide insight into the planned German regulations on DiGAs and digital care applications (DiPAs).

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