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Shelby Buettner advises pharmaceutical, medical device manufacturers, healthcare technology companies and healthcare providers on FDA regulatory and compliance matters. She regularly counsels clients on regulatory and policy considerations associated with mobile medical technology, telehealth, telemedicine, digital health and clinical research. Shelby assists clients, including academic medical centers and biotechnology manufacturers, with regulatory, transactional and compliance issues related to clinical research, manufacturing and quality issues and legislative initiatives affecting the healthcare industry. Shelby’s transactional practice focuses on advising investors on FDA regulatory and business considerations in pharmaceutical, medical device and clinical research transactions and contractual arrangements. She also assists investors and companies to conduct due diligence on FDA regulatory matters for mergers and acquisitions and other transactions. Read Shelby Buettner's full bio.

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 existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.

We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.

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On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 2016) (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.

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Shelby Buettner, Marshall Jackson, Jr., Lisa Schmitz Mazur and Dale Van Demark wrote this bylined article on a proposed US Senate bill to expand Medicare’s coverage of telehealth services. The bill would require the Center for Medicare and Medicaid Innovation to test the effectiveness of telehealth models, and cover through the Medicare program those models that meet criteria for effectiveness, cost and quality improvement.

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On December 14, 2016, President Obama signed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act). The ECHO Act seeks to expand the use of health care technology and programming to connect underserved communities and populations with critical health care services.

The ECHO Act builds upon the University of New Mexico’s world-renowned Project ECHO by encouraging the broader development and use of technology-enabled collaborative learning and care delivery models by connecting specialists with multiple other health care professionals through simultaneous interactive videoconferencing for the purpose of facilitating case-based learning, disseminating best practices and evaluating outcomes.

The ECHO Act requires the Secretary of the Department of Health and Human Services (HHS) to study technology-enabled collaborative learning and capacity building models, and the impact of those models on (1) certain health conditions (i.e., mental health and substance use disorders, chronic diseases, prenatal and maternal health, pediatric care, pain management, and palliative care), (2) health care workforce issues (e.g., specialty care shortages) and (3) public health programs.

Within two years of the enactment of the ECHO Act, the Secretary of HHS must submit a publically available report to Congress that:

  1. Analyzes the impact of technology-enabled collaborative learning and capacity building models, including, but not limited to, the impact on health care provider retention, quality of care, access to care and barriers faced by healthcare providers;
  2. Lists the technology-enabled collaborative learning and capacity building models funded by HHS over the past five years;
  3. Describes best practices used in adopting these models;
  4. Describes barriers to adoption of these models and recommends ways to reduce those barriers and opportunities to increase use of these models; and
  5. Issues recommendations regarding the role of technology-enabled collaborative learning and capacity building models in continuing medical education and lifelong learning, including the role of academic medical centers, provider organizations and community providers in such education and lifelong learning.

The recommendations made in HHS’s report may be used to integrate the Project ECHO model into health systems across the country.