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Lisa Schmitz Mazur advises health care providers and technology companies on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness. Lisa advises a variety of health care providers and technology companies involved in “digital health,” including assisting clients in developing and implementing telemedicine programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement. Lisa helps clients identify and understand the relevant legal issues, and develop and implement practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape.  Read Lisa Schmitz Mazur'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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As the Federal Communications Commission repeals the Open Internet Order—more commonly known as the net-neutrality rules—health care consumers and providers have been left wondering how this change will affect their ability to receive and deliver health care using digital health tools. In this On the Subject, we outline how changes in internet access will affect digital health and what the regulatory landscape will look like in the coming months and years.

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The Enhanced Nurse Licensure Compact (Compact) has now been adopted by 26 states, which means the Compact will be taking effect on January 19, 2018. Nurses who seek to practice telemedicine and deliver in-person care across state lines and who meet the Compact’s licensure requirements in these states will have one less obstacle to overcome going forward.

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The Office of the National Coordinator for Health Information Technology recently released a report detailing user experience research on patient access to health data. The Report sought to examine the experiences of individuals and processes of health systems, with commentary from medical record fulfillment administrators, to determine how the medical record request process can be improved for consumers.

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Jennifer Geetter and Lisa Schmitz Mazur wrote this bylined article on the regulatory implications of technology-supported devices, resources, and solutions that facilitate health patient-provider interaction. “Health industry regulators are struggling with how to apply the existing privacy regulatory regime, and the permitted uses and disclosures for which they provide, in this new world of healthcare innovation,” the authors wrote.

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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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Amanda Enyeart and Lisa Schmitz Mazur wrote this bylined article explaining how the HHS Office of Inspector General used a survey by the Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) to conclude that CMS made $729 million in inappropriate EHR incentive payments to physicians out of some $6 billion in such payments during the review period.

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As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc case. Senate Bill 1107, a bill that significantly eases the delivery of care via telemedicine in the state of Texas, was passed on May 18 and signed into law by Governor Abbott on May 30.

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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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Join members of the McDermott Employee Benefits team in May at one of these programs covering a variety of employee benefits topics.

The John Marshall Law School The Center for Tax Law & Employee Benefits 14th Annual Employee Benefits Symposium | May 1, 2017 | Chicago, Illinois | Speaker, Joseph S. Adams

Proposed 457(f) Regulations: Opportunities and Challenges | May 3, 2017 | Webinar presented by Mary K. Samsa, Joseph K. Urwitz, Ruth Wimer

M&A Workshop: New Developments and Key Legal and Tax Issues Throughout the Life Cycle of a Deal | May 4, 2017 | Chicago, Illinois | Speaker, Joseph S. Adams

Benefits Emerging Leaders Working Group | May 10, 2017 | Chicago, Illinois | Speakers, Lisa K. Loesel, Lisa Schmitz Mazur, Jacob M. Mattinson, Jeffrey Arnold, Sarah Raaii