While digital health innovation empowers us to better manage our health and live more productive lives, it also poses myriad regulatory, strategic and operational challenges. Edited and authored by McDermott’s team of distinguished digital health lawyers, The Law of Digital Health offers an overview of the highly dynamic and integrated components of the digital health ecosystem, with the goal of helping businesses thrive in this ever-evolving landscape. Over five chapters, we explore a broad spectrum of digital health innovation opportunities and the corresponding value proposition; review current and evolving legal and regulatory frameworks, theories, interpretations, and policy and enforcement initiatives in both the public and private sectors; and provide practical planning and implementation strategies for achieving the appropriate balance between the benefits of digital health innovation opportunities and the need to manage associated legal and regulatory risks.
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.
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.
A recent article in Kaiser Health News highlights the health risks associated with the increased effort to get patients home—namely, the need for families to gain and effectively deploy the skills needed to care for themselves and family members. The article highlights the risks (and increased rates) of infections, particularly in relation to catheters. However, it does not take much imagination to identify other conditions where at home care is critical.
Concise and easy to follow instructions are key, of course, but information technology can play a role here as well. While the business plan for this type of digital health strategy may not be as clear as others, this is the type of sector that could demonstrate the digital health opportunity in the effort to increase value in health care delivery.
A lot of us have argued that one of the floodgates for telemedicine has been reimbursement. If states and the Federal government more liberally reimbursed or required reimbursement for telemedicine service, we argue then a significant barrier to broader telemedicine will be removed. This is a valid argument, and the potential flurry of activity on Capitol Hill as of this writing (September 20, 2017) gives many hope that Medicare reimbursement for telemedicine may be greatly expanded soon.
Alas, another problem persists. A spate of recent surveys and reports on utilization demonstrate that awareness should be viewed as a similar sort of barrier. It is, of course, a generalization to say this, but consumers are largely unaware of the benefit being made available to them, or are unaware of the appropriate uses of a telemedicine service. It would be foolish to speculate as to the reasons why, but a recent trend may help to erode this barrier.
When it comes to customer service and user engagement, none are better than our technology industry. The West Coast tech giants clearly understand how to engage and attract users. The remarkable success of smart phones provides ample evidence—can you think of any other consumer product of comparably high-cost being as ubiquitous? It is also clear that the health care industry has failed to engage consumers as effectively. There are likely multiple reasons for this. Health care is: (1) highly regulated, resulting in limited ability to be quickly responsive to consumer demands; (2) run by professionals trained in many things, but not sales or consumer satisfaction and engagement; and (3) burdened both by a lack of competition at the point of sale, and by a third-party payment system that has so far proven to be impervious to the forces of disintermediation. Continue Reading The Way Forward for Telemedicine
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, the functioning of search engines, and online advertising techniques on commercial and political decisions.
The alleged “hacking” of the 2016 US presidential election, and the concerns about such activities in the 2017 European elections, will only heighten the interweaving discussions on free speech, national sovereignty, cyber security and the nature of privacy.
The use of artificial intelligence and machine-learning technologies has only added to the list of issues and areas of concern. The consequences of automobile accidents involving “self-driving” technologies, the “flash crashes” on securities markets due to algorithmic trading, and bias in systems designed to determine benefit eligibility, are requiring us to consider what happens when we defer judgment to machines, and highlighting the importance of quality in data sets and sensors.
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. Continue Reading More Federal Legislation Aimed at Expanding Medicare Coverage of Telehealth Services
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 the Texas Medical Board, and will better align Texas’ regulations with those found in other states.
Collaborative efforts between congressional offices and various health care stakeholders, as well as the feedback provided in response to the Bipartisan CHRONIC Care Working Group Policy Options Document released in December of 2015, have driven the Senate Finance Committee to introduce a draft of bipartisan legislation known as the CHRONIC Care Act, which seeks to modernize Medicare payment policies to improve the management and treatment of chronic diseases using telehealth.
The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care industry envision delivery models rivaling those imagined by celebrated science fiction authors, and claim that the integration of information technology into even the most basic health care delivery functions can reduce cost, increase access, improve quality and, in some instances, fundamentally change the way health care is delivered.
These visions are difficult to refute in the abstract; the technology exists or is being developed to achieve what just a few years ago seemed the idle speculation of futurists. But delivering this vision in an industry as regulated as health care is significantly harder than it may seem. While digital health models have existed for many years, the regulatory and reimbursement environment have stifled their evolution into fully integrated components of the health care delivery system.
Recent comments linking digital health tools to so-called “snake oil” has the channels of social media atwitter. (Add this post to the noise!) While some may decry the comparison, there is a lot we can learn from that perspective.
One of the challenges of broad digital health adoption is the simple fact that digital health encompasses such a broad array of technologies, usages and purposes. There is no one tonic that will cure a list of ailments; rather we are presented with shelves of solutions to even more shelves of challenges waiting to be addressed. Digital health includes, by my definition, the application of social media tools to preventative health and chronic disease management measures, as well as highly sophisticated data analytics applied to massive amounts of population health data to identify important health trends. It also includes home monitoring devices that keep health care providers informed of their patient’s at-home health condition, as well as telestroke programs that allow physicians to access needed expertise. The list is potentially endless, as new technologies created to address health issues and existing technologies are being put to use in the health care context. Continue Reading The Rocky Road of Evaluation for Digital Health Tools