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Digital health

Live Webinar: Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors

by Vernessa T. Pollard, McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark, Jeremy Earl, Jennifer S. Geetter, Jiayan Chen, Michael W. Ryan and Paul W. Radensky, MD | Jun 8, 2018 | Cybersecurity, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, General Interest, Mobile Apps, Telehealth

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

Surfing “Tech’s Next Big Wave”: Navigating the Legal Challenges in Digital Health

by Bernadette M. Broccolo and Lisa Mazur | May 4, 2018 | Big Data, Consumer Protection, Data Privacy, Mobile Apps

Fortune’s April 2018 cover story, “Tech’s Next Big Wave: Big Data Meets Biology,” conveys loudly and clearly that technological innovation is transforming the health care continuum—changing the way care is delivered, as well as how patients manage their ongoing health—and as patient demand for health innovation increases, more companies seem eager to hop on the digital health bandwagon. The article provides a thoughtful, realistic (and somewhat sobering) perspective on digital health innovation’s successes and other results to date. It also quite effectively uses real world stories to convey the human dimension of digital health. One is the story of a mother who manually sampled and recorded her son’s glucose levels 20 times a day before an automated monitoring system connected to a mobile app allowed them both to live their lives without constant interruption by this critical care management function. Another describes use of an artificial intelligence “command center” to expedite access to life-saving surgery by a man with an aortic dissection. These real-world examples drive home the fact that digital health is already making a profound difference in our lives by removing barriers to care that are critical to saving lives and managing chronic diseases.

What the article does not touch on, however, are the myriad, complex legal challenges that must be addressed at the earliest stages of the planning process and the intensifying interest of government oversight and enforcement bodies, such as the Federal Trade Commission, the Food and Drug Administration, the Office of Civil Rights of the Department of Health and Human Services, and the Securities and Exchange Commission, interested in protecting the safety and privacy of patients and consumers. Just last month, we saw the SEC charge Theranos’ CEO Elizabeth Holmes with fraud for allegedly misleading investors about the company’s ability to detect health conditions from a small sample of blood. Earlier this year, another “unicorn” start-up, Outcome Health, settled with the federal government after The Wall Street Journal reported that they allegedly misled advertisers with manipulated information. The United States has also brought claims against the private equity company investor of a compounding pharmacy that allegedly paid illegal kickbacks to marketing firms to induce prescriptions written by telemedicine providers for costly compounded drugs reimbursed by TRICARE.

Opportunities and Challenges of the Patient Data “Gold Rush”

Eric Topol, MD, director at the Scripps Research Institute, told Fortune that “the quest to retrieve, analyze and leverage” data “has become the new gold rush. And a vanguard of tech titans—not to mention a bevy of hot startups—are on the hunt for it.” There is no doubt that harnessing and analyzing big data provide virtually limitless fuel for digital health innovation of the type patients and consumers are demanding and that tech companies are eager to develop and commercialize. While optimism about the quest for big data is certainly justified, it must be tempered by caution and careful consideration of complex, multi-dimensional legal [...]

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Telehealth and the Changing Regulatory Landscape: Opportunities and Challenges in the Digital Health Ecosystem

by Lisa Mazur | Mar 6, 2018 | General Interest, Mobile Apps, Telehealth

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. (more…)

Podcast | Stephen Bernstein Joins ‘This Week in Health Innovation’ to Discuss Future of Digital Health

by Stephen W. Bernstein | Jan 24, 2018 | Big Data, Consumer Protection, Cybersecurity, Data Privacy, General Interest, Telehealth

Stephen Bernstein, global chair of McDermott’s Health Industry Advisory Practice Group, sat down with This Week in Health Innovation at the J.P. Morgan Healthcare Conference in San Francisco.

Stephen and Dr. Andre Berger, CEO of National ACO, discussed the role of advancing technologies in enhancing collaboration between key players in digital health—including doctors, heath plans, investors, and consumers and patients—and how digital health is necessary for improving care delivery and managing costs.

Listen to the full podcast.

Surviving Disruption: A Roadmap for Health Care Governance

by McDermott Will & Emery and Michael W. Peregrine | Dec 14, 2017 | Big Data, Consumer Protection, Data Privacy, Ecommerce, General Interest, Mobile Apps, Telehealth

Disruption of traditional health care is inevitable and poses a central challenge for health care governance. While the size and complexity of the health care industry have slowed the process of business disruption, its high costs and lack of convenience make it highly vulnerable to innovative, nontraditional competitors.

To make sure boards are well-prepared to address this challenge, McDermott Will & Emery and Kaufman Hall have partnered on a new thought leadership series designed to help you identify the signs of disruption, learn how to prepare your organization, and understand the implications for health care governance.

Get critical insights on how to spot, prepare for and manage disruption in your organization now:

Listen to Surviving Disruption Podcast, Episode 1: The Signs of Disruption.
Download Is Your Organization Disruption Ready? Questions to Assess Preparedness.
View our Top 5 Business Disruption Considerations for Corporate Governance infographic.
Watch our Behind the Scenes: The Making of the Surviving Disruption Podcast Series video.

Subscribe to the Surviving Disruption podcast on iTunes, SoundCloud and Pocket Casts, and keep an eye on the Resource Center for Episode 2: The Path Through Disruption and Episode 3: A Governance Foundation, being released on December 27 and January 10.

FTC Weighs-in on Telehealth, Comments on Delaware’s Occupational Therapy Practice Rule

by McDermott Will & Emery, Ashley Fischer, Lisa Mazur and Marshall E. Jackson, Jr. | Sep 15, 2016 | General Interest, Mobile Apps, Telehealth

On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via telehealth in Delaware (the Proposed Regulation). The FTC’s comments to the Proposed Regulation follow its comments to Alaska’s telehealth legislation earlier this year and evidence its continued focus on telehealth’s ability to foster flexibility in health care delivery by increasing practitioner supply; encouraging competition; and improving access to affordable, quality health care.

By way of background, in 2015, Delaware amended its Insurance and Professions and Occupations Code (the Code) to include the regulation of telehealth and telemedicine services, including the delivery of occupational care remotely under existing, in-person standards of care. Consistent with the Code, the Delaware Board of Occupational Therapy Practice (the Board) revised its rules and regulations to address telehealth services. The Proposed Regulation defines telehealth as “the use of electronic communications to provide and deliver a host of health-related information and health care services, including occupational therapy related information and services, over electronic devices. Telehealth encompasses a variety of occupational therapy promotion activities, including consultation, education, reminders, interventions, and monitoring of interventions.”

The Proposed Regulation gives Occupational Therapist and Occupational Therapist Assistant licensees’ (Licensees) discretion in assessing and determining the appropriate level and type of care for an individual patient, provided that certain requirements are satisfied. Specifically, under the Proposed Regulation, Licensees that provide treatment through telehealth must have an active Delaware license in good standing to practice telehealth in the state of Delaware. In addition to obtaining informed consent and complying with confidentiality requirements, the licensee must also: (1) be responsible for determining and documenting that telehealth is an appropriate level of care for the patient; (2) comply with the Board’s rules and regulations and all current standards of care requirements applicable to onsite care; (3) limit the practice of telehealth to the area of competence in which proficiency has been gained through education, training and experience; (4) determine the need for the physical presence of an occupational therapy practitioner during any interactions with patients, if he/she is the Occupational Therapist who screens, evaluates, writes or implements the plan of care; (5) determine the amount and level of supervision needed during the telehealth encounter; and (6) document in the file or record which services were provided remotely. (24 Del. Admin. Code § 2000-4.2.)

Staff of the FTC’s Office of Policy Planning and its Bureaus of Competition and Economics, responding to the Board’s request for public comments, stated that by not imposing rigid and unwarranted in-person care and supervision requirements, the Proposed Regulation could have various positive impacts, including: (1) improving access to cost-effective, quality care, especially for patients with limited mobility; (2) reducing Medicaid’s transportation expenditures as well as individuals’ pecuniary and time costs; (3) addressing anticipated workforce shortages in the health care sector by increasing practitioner supply and facilitating care of an aging population; and (4) enhancing competition, consumer choice and access to [...]

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Digital Health: An Improving Environment for Investors

by Dale C. Van Demark and Lisa Mazur | Jul 12, 2016 | General Interest, Mobile Apps, 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.

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AMA Approves New Ethical Guidance Policy and Encourages Telemedicine Training for Students and Residents

by McDermott Will & Emery and Lisa Mazur | Jun 20, 2016 | Consumer Protection, Data Privacy, General Interest, Mobile Apps, Telehealth

New Ethical Guidelines

On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on a report from the AMA Council on Ethical and Judicial Affairs and builds upon the AMA’s 2014 telemedicine guidance.

Consistent with past guidance from AMA and other professional organizations, the AMA notes that the ethical responsibilities of physicians are the same – regardless of whether the physician communicates with a patient in-person or remotely – and encourages providers to recognize the potential uses and limitations of technology when delivering care. “Telehealth and telemedicine are another stage in the ongoing evolution of new models for the delivery of care and patient-physician interactions,” said AMA Board Member Jack Resneck, MD. “The new AMA ethical guidance notes that while new technologies and new models of care will continue to emerge, physicians’ fundamental ethical responsibilities do not change.”

The 2016 policy recommends that once a patient-physician relationship is established, physicians who engage in telemedicine by responding to individual health queries electronically or providing clinical services through telemedicine:

Must disclose financial or other interests in certain telemedicine applications or services
Must protect patient privacy and confidentiality
Should inform patients of the limitations of the telemedicine encounter
Should encourage patients to inform their primary care doctor about the encounter
Should advise patients how to arrange follow-up care
Should, when necessary, recommend the use of a telepresenter or other health care professional at the originating site (e., the patient’s physical location)

Notably, the 2014 guidance required that a patient-physician relationship be established prior to the provision of telemedicine services. The relationship could be established during a face-to-face examination, through a consultation with another physician, or by meeting the evidence-based practice guidelines developed by major medical specialty societies. While the 2014 guidance did not specify whether the face-to-face examination must occur in-person, rather than digitally, many interpreted this requirement to be satisfied via an interactive telemedicine encounter.

In addition, the 2016 policy formally recognizes the importance of a “coordinated effort across the profession,” which includes clarifying standards and promoting access to technology. That said, the 2016 policy still requires the licensure of physicians in the state in which the patient is located. (As a general rule, physicians that practice telemedicine are subject to the licensure rules of both the state in which their patient is physically located and the state in which the provider is practicing.) One potential avenue for facilitating multi-state licensure is the Federation of State Medical Boards’ Interstate Medical Licensure Compact, which offers a streamlined licensure process in each Compact state. The Compact has been adopted by 17 states thus far and more are expected to join this year and in 2017.

In sum, the AMA’s new ethical guidance should help physicians to better understand how their fundamental ethical responsibilities may play out differently when patient interactions occur through technology, and how this technology can [...]

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FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

by Jennifer S. Geetter, Michael W. Ryan and Vanessa K. Burrows | Feb 17, 2016 | Big Data, General Interest

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel infrastructure to conduct post-market effectiveness studies.

Sentinel is an electronic surveillance system that aggregates data from electronic medical records, claims and registries that voluntarily participate and allows the agency to track the safety of marketed drugs, biologics and medical devices. As of August 2015, the Sentinel database includes information from 193 million individuals, 4.8 billion instances of prescription dispensing, 5.5 billion unique encounters and 51 million acute inpatient stays.

The FDA currently uses the system to assess post-market safety issues. However, in a February 3, 2016, workshop, Dr. Woodcock announced that the FDA is in the early stages of adapting the Sentinel infrastructure to develop the “Guardian” system, which the agency intends to use to “actively gather information about the performance of regulated medical products” used in health care. At the same workshop, Dr. Steven Anderson of the FDA’s Center for Biologics Evaluation and Research (CBER) described the Guardian system as a parallel system to Sentinel that will rely on the Sentinel infrastructure to assess product effectiveness. According to Dr. Anderson, the FDA is currently assessing the feasibility of using Sentinel to perform effectiveness studies, and over the next five years, intends to develop the system to support a range of clinical trial designs.

The FDA envisions that the Guardian system will help the agency and external researchers quickly and less inexpensively answer questions about the performance of medical products that would otherwise require expensive, time-consuming clinical investigations to assess. The FDA did not specifically address how the agency intends to use the effectiveness data developed using the Guardian system.

The proposed Guardian system represents the FDA’s latest attempt to harness the power of “big data” and to participate in the changes precipitated by digital health strategies and tools to address FDA priorities. In 2014, the FDA launched its openFDA initiative, which gives the general public access to several of the agency’s public data sets (e.g., adverse event reports). Moreover, in December 2015, the FDA launched a beta version of its precisionFDA platform, which is an online, cloud-based platform that is intended to allow scientists from the public and private sectors to test, pilot and validate existing and new bioinformatics approaches for processing the large amounts of data collected using next-generation sequencing (NGS) technology.

The FDA’s efforts to launch the Guardian system mirror “big data” initiatives by other private and public stakeholders seeking to leverage data capture and data mining to pursue important public health, quality improvement, research and cost-containment efforts.

In with the New: 2015 Privacy, Advertising and Digital Media Predictions – Part I

by Jennifer S. Geetter | Jan 7, 2015 | Big Data, Consumer Protection, Data Privacy, General Interest, Mobile Apps

What privacy, advertising and digital media trends will make headlines in 2015? Digital Health for one, Big Data for another.

Digital Health

The 2015 International Consumer Electronics Show (CES) started yesterday. Sessions like “Sensibles: The Smarter Side of Wearables” and “DIY Health: Consumer Accessible Innovation” suggest that the consumer health issues explored by the Federal Trade Commission (FTC) last Spring (see our blog post here) are increasingly relevant. Most notably, as more health-related information becomes digital, digital health businesses will need to revisit long-standing privacy, intellectual property protection, notice and consent practices that may not be well-suited to the more sensitive category of consumer-generated health information (CHI) (i.e., health-related information that consumers submit to or through mobile apps and devices). In many cases, the law is underdeveloped and businesses must develop and implement their own best practices to demonstrate good faith as stewards of CHI.

We predict that CHI and the issues raised by its collection, use, disclosure and storage will stay on the FTC’s radar during 2015. Perhaps the FTC will offer some insight about its position on CHI through guidance or regulatory activity related to a digital health business.

With mobile devices proliferating, the volume, versatility and variety of consumer-generated data, including CHI, also is proliferating. CHI typically stands outside of HIPAA’s regulatory silo. HIPAA regulates health plans, health care clearinghouses, health care providers who engage in standardized transactions with health plans and the business associates that assist health plans, clearinghouses and providers, and need protected health information to provide that assistance. Mobile medical services and environments, however, typically fall outside of this framework: most mobile apps, for example, are used directly by consumers, and often at the direction of and under the control of plans and providers. HIPAA may have, however, more reach into the growing business-to-business mobile app sector.

But, in the CHI arena, the sources of privacy and security regulation are murky. Among likely hot topics in 2015 are:

When is consumer-generated information also consumer-generated health information?
Can data ever be “de-identified” or made anonymous in light of the so-called mosaic (or pointillist) effect?
What role can the “pay with data” model play in consumer protection?
Is all CHI deserving of the same level of protection?
What sources of oversight exist and are they sufficient?

The news is ripe with references to data “privacy” and data “security,” but the sensitivity associated with health information requires thinking about data “stewardship” – a broader concept that encompasses not only privacy and security but also data asset management and data governance. Data stewardship captures not only data as an asset, but also as an opportunity to earn public trust and confidence while preserving innovation.

We predict that how to be good data stewards will be a critical issue for digital health businesses in 2015 and that forward-looking and transparent efforts at self-policing will be key to not only avoiding regulatory scrutiny but also fostering consumer trust.

Big Data

Big Data was big news [...]

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