It has been only a little over six months, and already 2018 has been a busy year for digital health, particularly in the area of Medicare reimbursement. The Centers for Medicare and Medicaid Services (CMS), Congress, the Medicare Payment Advisory Commission, and the US Department of Health and Human Services (HHS) Office of Inspector General
Across the health care sector, telemedicine is naturally and strategically being integrated into health care delivery and treatment plans as targeted and efficient solutions to specific health issues by hospitals, medical groups and drug-to-consumer telemedicine companies.
Telemedicine is no longer viewed as a secondary option for care—it is a new standard of care that is…
As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and investment among stakeholders or all sorts.
Health systems and other institutional providers are playing a more active investment role in the commercialization of biomedical, digital health, and other important health care discoveries in order to remain competitive, secure their positions as industry leaders and generate growth opportunities. This more active role also affords their internal innovators (e.g., physicians and scientists) to play a meaningful role in accelerating the commercialization of home-grown discoveries that may otherwise be left in “the valley of death” between government-funded basic research and later stage, industry-funded commercialization. Drug and medical device manufacturers, venture capital, private equity firms, large donors and other investors are injecting significant capital into fueling research, development and commercialization of health care technology innovation. On the one hand, health care systems and providers welcome such external co-investors who bring sophisticated expertise in product and market research, technology innovation, valuation and strategy capabilities, as well as access to networks of potential co-investors. For such external co-investors, on the other hand, joining forces with health care institutions affords much needed access to the expertise and thought leadership of clinicians, scientists and health technology innovation; a ready‑made proving ground and “anchor customer” for the product; and the halo effect of the health care provider around the co-investor’s clinical care and research reputation. The theory and the hope is that the combined capital and the different, but complementary, expertise, experience and perspectives of such co‑investors provides a formula for financially successful innovation that is transformative and not merely disruptive.…
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
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…
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…
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. …
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.
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.…
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. …