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.
What if you didn’t have to take time out of your day to see a physician in person when you needed a prescription? What if a diagnosis could be delivered over video chat? What if your psychiatrist was available at the press of a button or swipe on your screen?
These options are fast becoming a reality, as telehealth (or telemedicine) continues to take hold in a health care system that is desperate for increased efficiency and higher quality outcomes. And while telehealth offers exciting new possibilities in terms of convenience and access for patients, it also poses new regulatory challenges for industry stakeholders still learning the new rules of the game in today’s digital health ecosystem.
The Chronic Care Act
One of the biggest drivers of change in the industry right now is the Chronic Care Act. Last month, as part of the House and Senate budget deal to fund the government through March 23, legislators included the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017, which will increase reimbursement for a lot of different telemedicine programs.
For example, if you went to a rural hospital and they didn’t have a stroke neurologist and you were having a stroke, you would have an ED doctor with no stroke specialty diagnosing you—not an ideal situation. With telemedicine, it’s now possible for rural doctors to consult with specialty doctors at renowned sites, which the government will fund thanks to the Chronic Care Act. Continue Reading Telehealth and the Changing Regulatory Landscape: Opportunities and Challenges in the Digital Health Ecosystem
The explosion in digital health solutions that connect consumers with licensed health care providers (e.g., nurses, nutritionists, physicians) and laypersons who have certain informal training (e.g., wellness guide, lifestyle coach, outreach partner) has the potential to blur the lines between what constitutes the practice of a licensed health care profession and what does not (usually because the service is intended to be merely informational or educational). Why does it matter which side of the line a particular service falls on? If a service is one that is delivered by a licensed health care professional, there are various state laws and regulations that may govern the activity, and different potential causes of action that may apply in the event a consumer/patient is injured in the process.
- If a digital health solution connects a consumer to an individual who is engaged in an activity that is normally performed by a licensed health care professional, state laws and regulations governing health care professionals likely apply.
As background, state professional boards regulate individuals who deliver health care services to the public (e.g., nursing, psychology, medicine, phlebotomy). What falls within the definition of a specific health care service can be very broad and varies state to state. Continue Reading Walking the Fine Line between the Delivery of Health Care Services and Information/Educational Support
This past fall, after months of speculation, President Trump declared the opioid crisis sweeping the United States a national public health emergency. Upon the president’s declaration, Acting Health and Human Services Secretary Eric D. Hargan made a formal declaration under Section 319 of the Public Health Service Act, making available an exception to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Haight Act) that would allow providers to prescribe controlled substances using telemedicine without first conducting an in-person visit. Currently, the Haight Act restricts the ability of a provider to prescribe controlled substances using telemedicine without first conducting an in-person examination, unless an exception applies. For a detailed discussion regarding the Haight Act and the restrictions on the use of telemedicine to prescribe controlled substances within the context of the treatment of opioid addiction and mental health generally, our latest article addresses the opioid crisis and access to mental and behavioral health providers.
The declaration of a public health emergency allows the US Drug Enforcement Agency (the DEA) to remove the restriction of prescribing controlled substances using telemedicine for the treatment of opioid addiction, but the DEA has not promulgated any rules or guidance on the subject. The lack of development has drawn the interest of Senators Claire McCaskill, Lisa Murkowski, and Dan Sullivan. The senators, in a January 30, 2018, letter to Robert Patterson, the acting administrator of the DEA, note that the restriction on the use of telemedicine from prescribing addiction treatment medications continues to have a harmful impact on rural Americans, citing specifically to Missouri, where 98 out of its 101 rural counties lack a licensed psychiatrist. In this letter, the senators call on Mr. Patterson to expedite the rulemaking process to create a special registration process to permit the prescription of opioid-based medication-assisted addiction therapies via telemedicine without first performing an in-person visit.
McDermott Will & Emery LLP will continue to monitor whether progress is made to develop this expedited rulemaking process and report updates on this blog.
The opioid epidemic is making the United States acutely aware of the horrors of substance abuse disorders and the limited means of treating the individuals suffering from addiction. Rural America is among the places hit hardest by opioid addiction while also having limited access to mental and behavioral health providers.
Telemedicine offers a viable solution to provider shortages, particularly with an eye toward mental health care professionals. Although telemedicine alone will not remedy the shortage of psychiatrists in the United States, the technology does possess the capability of greatly increasing access to them; however, a large driver of psychiatric care is provided through pharmaceutical treatments.
The ability for providers to prescribe pharmaceuticals, particularly controlled substances, to patients the provider has not seen in person is limited by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Haight Act). The relevance of the Haight Act, a law that went into effect almost nine years ago, has been revitalized, but the opioid epidemic and advances in psychiatric treatment are now demonstrating the law requires clarification through amendment to improve access to pharmaceutical treatments and, in turn, increase access to mental health care.
Reprinted with permission, copyright © 2018, The Bureau of National Affairs, Inc.
On February 9, 2018 after a brief shutdown, Congress passed and President Trump signed the Bipartisan Budget Act of 2018, a two-year budget agreement that includes funding for the operation of the federal government until March 23, 2018. The law includes significant health care policy changes impacting Medicare, Medicaid and other federal health agencies. In addition to raising federal spending caps enacted in the Budget Control Act of 2011, this legislation includes additional spending for health care priorities. Here we break down some of the changes affecting telehealth.
Expanded Access to Telehealth Stroke Services
The new law expands, beginning in 2019, the ability of patients presenting with stroke symptoms at hospitals or mobile stroke units to receive a timely telehealth consultation with a neurologist in order to determine the best course of treatment. The provision eliminates the current geographic restriction that limits originating sites to rural areas, meaning distant site providers delivering telestroke services could receive a professional fee for delivering the consultation to patients located anywhere in the United States, provided that the other Medicare telehealth coverage requirements are satisfied (e.g., type of provider, type of technology). Continue Reading Bipartisan Budget Act of 2018 Includes Significant Changes in Medicare, Other Federal Health Programs
The General Data Protection Regulation (GDPR) establishes protections for the privacy and security of personal data (Personal Data) about individuals in the European Union (EU) single market countries, and potentially affects the clinical and other scientific research activities of academic medical centers and other research organizations in the United States.
This On the Subject includes frequently asked questions that discuss the extent to which United States research organizations must comply with GDPR when conducting research. Future coverage will address the impact of GDPR on other aspects of the United States health care sector.
Enforceable in all EU member states on 25 May 2018, the General Data Privacy Regulation will require action by organisations both inside and outside the European Union to ensure compliance with this far-reaching privacy legal framework. Compliance is even more urgent given that the GDPR provides for large penalties in cases of infringement. As some entities are not yet aware of the extent to which GDPR may be applicable to them, the GDPR expressly applies to organisations established outside the European Union that offer paid or free goods or services to EU data subjects or monitor EU data subjects’ behaviour.
Within this article, we review steps for a risk based, prioritization approach to GDPR compliance and how companies can adjust their policies and practices on a pragmatic basis to help ensure compliance.
On January 30, Attorney General Jeff Sessions announced a surge of Drug Enforcement Administration (DEA) agents and investigators over the coming month and a half, focused on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of opioid drugs. The DEA will examine distribution and inventory data reported to the DEA by prescription drug manufacturers and distributors for “patterns” and “outliers” for further investigation.
As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to changing the landscape for product research, development and commercialization. Modernization of the existing legal framework has not kept pace with the rate of digital health innovation, leaving no shortage of obstacles, misalignment and ambiguity for those in the wake.
What did we learn in 2017 and what’s to come on the digital health frontier in the year ahead? From advances and investments in artificial intelligence (AI) and machine learning (ML) to the increasingly complex conversion of health care innovation and policy, McDermott’s Digital Health Year in Review details the key developments that shaped digital health in 2017, along with planning considerations and predictions for the health care and life science industries in 2018. Continue Reading On the Digital Health Frontier: Developments Driving Industry Change in 2018