Join McDermott next Wednesday for a live webinar on the unique considerations in developing and procuring AI solutions for digital health applications from the perspective of various stakeholders. We will discuss the legal issues and strategies surrounding:

  • Research and data mapping essential to the development and validation of AI technologies
  • Protecting and maintaining intellectual property rights in AI solutions
  • Technology development
  • Risk management and mitigation for various contractual arrangements, including contracts with customers, vendors and users

We will also focus on the trends in US law for AI solutions in the digital health space, and present actionable advice that will help you develop an effective strategy for developing and procuring AI solutions for digital health applications.

Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors
Wednesday, June 13, 2018 | 11:00 am CT | 12:00 pm ET
Register Here

 

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential to provide valuable insights into disease and wellness and help solve challenging public health problems.

There is tremendous enthusiasm over the possibilities of leveraging this data for secondary use–i.e., a use of data that is distinct from the purpose for which it was originally collected. However, such secondary use is often subject to intersecting legal and regulatory regimes–including HIPAA, the Common Rule, and the Federal Food, Drug, and Cosmetic Act and its implementing regulations–that are not fully harmonized.  This lack of harmonization in requirements, coupled with the wide range of industry players involved–including regulators, academic medical centers, health systems, payers, technology companies, manufacturers and industry entities, research institutions, registries, and professional societies, to name a few– presents challenges that require careful planning and implementation. While regulators have recently taken significant steps to reconcile the differences among these laws and provide a path forward for harnessing the potential of big data, some specific requirements within these individual regulations continue to present challenges.

It is critical for academic medical centers and teaching hospitals, which stand at the intersection of government-funded research and industry-sponsored research, and are also paving the way in partnerships with non-traditional health care players—to understand the evolving legal framework and business and compliance imperatives behind the quest for digital health information.

During the AHLA Annual Meeting on Tuesday, June 26, McDermott partner Jiayan Chen will review trends and the value proposition relating to secondary use, with a particular focus on challenges presented by secondary use in the precision medicine and digital health context.  Along with co-presenter Leah Voigt, she will explore key regulatory and sub-regulatory developments relating to the secondary use of data under FDA regulations, the Common Rule, and HIPAA, and will also use case studies to explore, in a practical context, the challenges and ambiguities that remain when pursuing internal secondary use initiatives and external collaborations, including implementation and contracting tips, insights, and strategies.

Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data
AHLA Annual Meeting, Chicago, IL | June 26, 2018 | 9:45 – 10:45 am | Registration and program details.

McDermott’s Cocktail Reception during the AHLA Annual Meeting
The Art Institute of Chicago | June 26, 2018 | 6:00 – 8:00 pm
Following the programming on Tuesday, we invite you to join us for our annual cocktail reception at The Art Institute of Chicago. We look forward to an evening of networking, cocktails and private gallery tours with our colleagues, friends and fellow AHLA members. RSVP today!

Lack of a sufficient risk analysis continues to be one of the most commonly alleged violations in Office for Civil Rights (OCR) HIPAA enforcement actions, appearing in half of all OCR settlements announced in the last 12 months and in almost all of the $1 million-plus settlements during that time period. Significant confusion remains across the health care industry as to what actually constitutes a compliant risk analysis for purposes of the HIPAA Security Rule. On April 30, 2018 OCR issued guidance discussing the differences between a HIPAA Security Rule risk analysis and a HIPAA compliance “gap analysis.” Drawing from our experience reviewing clients’ historical risk analysis documents, helping clients to navigate OCR investigations and negotiating several recent HIPAA settlements with OCR, we elaborate on what constitutes a compliant HIPAA Security Rule risk analysis, discuss common risk analysis misunderstandings and pitfalls, and encourage covered entities and business associates to consider whether to conduct these reviews under attorney-client privilege.

Continue Reading.

As the telemedicine landscape continues to evolve and new capabilities come to bear, those working in the industry will face a diverse mix of legal and regulatory hurdles as stakeholders begin to leverage new avenues and options for care delivery. This evolution requires practitioners to understand the legal frameworks that will continue to change as regulators attempt to keep pace with evolving technology.

To help address the complexities of the telemedicine regulatory environment — and those across the digital health ecosystem at large — we partnered with the American Health Lawyers Association to release “The Law of Digital Health,” which details legal realities for digital health leaders and their advisors looking to bring new tools to market or expand their existing positions.

Unique Legal and Regulatory Considerations Applicable to Telemedicine

The “telemedicine sector” is undoubtedly complex and rife with nuance, beginning with how it is defined, which significantly varies among payers, regulators, accrediting bodies and providers. Adding to the intricacy are the variations in telemedicine regulation, depending on factors such as the patient’s location/geography and care setting, coverage and reimbursement or type of technology used. Despite these complexities, organizations are moving forward with their telemedicine initiatives and navigating these issues because of the great potential telemedicine has to expand access to care.  Continue Reading Telemedicine’s Complex Legal Landscape

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.

Visit www.mwe.com/lawofdigitalhealth to order this comprehensive legal and regulatory analysis, coupled with practical planning and implementation strategies. You can also download the Executive Summary and hear more about how Digital Health is quickly and dynamically changing the health care landscape.

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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.

  1. 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.

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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