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Consumer Demand in Digital Health Data and Innovation

Digital health companies are producing increasingly innovative products at a rapidly accelerating pace, fueled in large part by the expansive healthcare data ecosystem and the data strategies for harnessing the power of that ecosystem. The essential role data strategies play make it imperative to address the data-related legal and regulatory considerations at the outset of the innovation initiative and throughout the development and deployment lifecycle so as to protect your investment in the short and long term.

The Evolution of Digital Health

Digital health today consists of four key components: electronic health records, data analytics, telehealth, and patient and consumer engagement tools. Electronic health records were most likely first, followed very closely by data analytics. Then telehealth deployment rapidly increased in response to both demand by patients and providers, the improved care delivery and access it offers, and more recently, the expanded reimbursement for telehealth solutions. Each component of digital health was developed somewhat independently, but they have now converged and are interrelated, integral parts of the overall digital health ecosystem.

The patient and consumer engagement dimension of digital health has exploded over the last five years. This is due, in large part, to consumer and patient demand for greater engagement in the management of their healthcare, as well as the entry of disruptors, such as technology service providers, e-commerce companies, consumer products companies and entrepreneurs. At this point in the evolution of the digital health landscape, the patient and consumer engagement tool dimension pulls in all other key components and no digital health consumer engagement tool is complete without the full package.

Data Strategies and Collaborations as Key Innovation Ingredients

No digital health initiative can be developed, pursued or commercialized without data. But the world of data aggregation and analytics has also changed significantly and become immensely complex in recent years. Digital health innovation is no longer working exclusively within the friendly confines of the electronic health record and the carefully regulated, controlled and structured data it holds. Today, digital health innovation relies on massive amounts of data in a variety of types, in various forms, from a wide variety of sources, and through a wide variety of tools, including patient and consumer wearables and mobile devices.

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CMS Innovation Center Proposes Telehealth Solutions in ET3 Model

As part of its efforts to provide patient-centered care and reduce costs for Medicare beneficiaries, the Centers for Medicare and Medicaid (CMS) have developed an Innovation Center model for ambulance care teams: Emergency Triage, Treat, and Transport (ET3). As part of this model, the agency has proposed two potential telehealth offerings: 1) An individual who calls 911 may be connected to a dispatch system that has incorporated a medical triage line to be screened for eligibility for medical triage services prior to ambulance initiation, and 2) telehealth assistance via audiovisual communications technologies with a qualified provider once the ambulance arrives.

Key participants in the ET3 model will be Medicare-enrolled ambulance service suppliers and hospital-owned ambulance providers. In addition, to advance regional alignment, local governments, their designees or other entities that operate or have authority over one or more 911 dispatches in geographic areas where ambulance suppliers and providers have been selected to participate in the ET3 model will have an opportunity to access cooperative agreement funding. As such, both state regulations and CMS regulations will apply to the use of telehealth offerings under ET3. This post explores early-stage questions of ET3 implementation and reimbursement, the intersection of state laws governing telehealth, and what potential participants and telehealth companies should know about the program.

How will CMS support the ET3 model implementation?

The key telehealth development for the ET3 program is that CMS expects to waive the telehealth geographic and originating site rules as necessary to implement the model, including waivers that will allow participants to facilitate telehealth at the scene of a 911 response. Additional information on these waivers is expected to accompany the ET3 Request for Applications (RFA), slated for release this summer. Overall, Medicare coverage requirements provide that the patient must be in an approved originating site at the time of the telehealth visit (e.g., hospital) and must be located within a rural area. CMS has waived these two requirements for other programs, such as the SUPPORT for Patients and Communities Act (the SUPPORT Act) in October 2018, which eliminated the originating site restriction for substance use disorder treatment, because doing so is necessary for these programs to succeed.

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Digital Health Drives Forward – A Roadmap of Regulations

New digital health regulations arose at the federal and state level in 2018, bolstering the existing legal framework to further support and encourage digital health adoption in the context of care coordination and the move to value-based payment. McDermott’s 2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement report – the second in a four-part series – highlighted these developments within the digital health landscape. These efforts brought changes to coverage of telehealth and other virtual care services, as well as information gathering for regulatory reform, and can help bridge the gap between research, funding and implementation as regulations build a framework within which companies can deploy their products, receive reimbursement and demonstrate value to patients. Here we outline digital health developments from the second half of 2018 and how they can help drive digital health forward in 2019. For a closer look at key care coordination and reimbursement developments that shaped digital health in 2018, along with planning considerations and predictions for the digital health frontier in the year ahead, download our full report.

To view the first report in the series, 2018 Digital Health Year in Review: Focus on Data, click here.




Upcoming FTC Workshop on Informational Harm | Next Brushstrokes on the FTC’s Consumer Privacy and Security Enforcement Canvas

On September 29, the Federal Trade Commission (FTC) formally announced a December 12th workshop on informational injury—the injury a consumer suffers when information about them is misused. The workshop will address questions such as, how to characterize and measure such injury and what factors businesses and consumers should consider the benefits and risks of collecting, using and providing personal information so as to gain further perspective for how the FTC should apply its legal framework for privacy and security enforcement under 15 USC § 45 (Section 5). In her September 19th remarks to the Federal Communications Bar Association, Commissioner Maureen Ohlhausen, the Acting Chairman of the FTC, metaphorically characterized the workshop’s purpose as providing the next brushstrokes on the unfinished enforcement landscape the FTC is painting on its legal framework canvas. The full list of specific questions to be addressed may be accessed here.

Background. The FTC views itself as the primary US enforcer of data privacy and security, a role it recently assumed. While the FTC’s enforcement against practices causing informational injury through administrative proceedings goes back as far as 2002, its ability to pursue corporate liability for data security and privacy practices under its Section 5 “unfair or deceptive trade practices” jurisdiction was only ratified in 2015 by the US Court of Appeals for the Third Circuit in FTC v. Wyndham Worldwide Corporation. The FTC has actively invoked its enforcement authority but, in doing so, has been selective in determining which consumer informational injuries to pursue by questioning the strength of evidence connecting problematic practices with the injury, examining the magnitude of the injury and inquiring as to whether the injury is imminent or has been realized. (more…)




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