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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Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing

The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program Final Rule published on November 15, 2017 (the Final Rule). Among many other developments, the Final Rule expands allowable telehealth reimbursement under the calendar year (CY) 2018 Physician Fee Schedule, List of Medicare Telehealth Services (list) and permits virtual sessions in certain circumstances under the Medicare Diabetes Prevention Program Expanded Model (MDPP, or the Program). The regulations are effective January 1, 2018.

“New” and “Add-On” Telehealth Services Slated for Reimbursement

CMS evaluates requests for the addition of telehealth services on the basis of two categories: (1) services that are similar to services already on the list and (2) services that are not similar to services already on the list. An evaluation of a category (2) service requires CMS to assess, based on the submission of evidence, whether the use of a telecommunications system to furnish the service “produces demonstrated clinical benefit to the patient.”
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Although the incorporation of technology into human endeavours—commercial, political and personal—is a normal component of technological innovation, the advent of artificial intelligence technology is producing significant challenges we have not felt or understood with earlier innovations. For many years, for example, there has been speculation, research and public debate about the impact of the internet,

Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities.

The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar.
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On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early 2016 and referred to the Senate Committee on Finance. As we previously reported on February 29, 2016, this iteration of the proposed bill also focuses on promoting cost savings and quality care under the Medicare program through the use of telehealth and remote patient monitoring (RPM) services, and incentivizing such digital health technologies by expanding coverage for them under the Medicare program—albeit using different terminology. Chiefly, the CONNECT Act of 2017 serves as a way to expand telehealth and RPM for Medicare beneficiaries, makes it easier for patients to connect with their health care providers and helps reduce costs for patients and providers. As with the previous iteration, the CONNECT Act of 2017 has received statements of support from over 50 organizations, including the American Medical Association, American Telemedicine Association, Healthcare Information and Management Systems Society, Connected Health Initiative, Federation of State Medical Boards, National Coalition on Health Care and an array of vendors and health systems.
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Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s currently limited coverage of telehealth services and opportunities for innovation.

The Telehealth Improvement Act would require the Center for Medicare and Medicaid Innovation (CMMI) to test the effect of including telehealth services in Medicare health care delivery reform models. More specifically, the Act would require CMMI to assess telehealth models for effectiveness, cost and quality improvement, and if the telehealth model meets these criteria, then the model will be covered through the Medicare program.
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Texas telehealth requirements will significantly change in the near future if Texas Senate Bill 1107 is passed into law, as it removes the controversial “face-to-face” or in-person consultation requirement to establish a physician-patient relationship and lawfully provide telehealth and telemedicine services within the state. This bill comes after a six-year-long battle between telemedicine stakeholders and

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is

Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the numerous regulatory bodies responsible for overseeing different aspects of digital health. The following illustration identifies the numerous regulatory bodies that have been