Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product research, development and commercialization, for long-standing and new stakeholders alike. Lawmakers and regulators made meaningful progress towards modernizing the existing legal framework to both protect
Healthcare is facing an age of disruption from new market entrants and players outside the traditional healthcare paradigm. Unexpected partnerships are bringing fresh solutions to market and changing how business is done and care is delivered.
Many of these new partnerships are arising in conjunction with innovation investments by hospitals and health systems (HHSs). HHSs have always been a source of significant innovation through research and other avenues, but traditionally this work has been largely decentralized. Today, HHSs are formalizing their innovation efforts and finding ways to capitalize on those opportunities—which are abundant, thanks to HHSs’ physician workforce, research infrastructure, and access to patients and their data. These centralized innovation incubators make it easier for non-traditional players, such as tech companies, to pool resources with an HHS and bring game-changing solutions to market in an expedited fashion.
Whether they occur through an innovation center, cross-industry ventures in the healthcare sphere are still in their infancy. As such, they pose a number of challenges that require careful planning and a flexible mindset.
Vet Your Opportunities Thoroughly
In today’s push for value-driven transformation, HHSs and other health industry stakeholders have hundreds if not thousands of opportunities for partnerships knocking on their door. Diverse players, from tech vendors to start-ups to private equity firms, are queuing up for a chance to participate in the burgeoning health sector.
Faced with these abundant—and often novel—opportunities, HHSs have the task of sorting through their options and developing an efficient process to vet, select and pursue them. Too many choices is a good problem to have, but HHSs nonetheless face challenges as they determine the best way to triage potential partnerships and ventures. Key infrastructure components at HHSs include education of and buy-in by governing board, development of investment guidelines that align with mission, and building the innovation structure and team (often with contributors who come from outside of “traditional healthcare”). Once that infrastructure has been established, the HHS will be able to evaluate and pursue innovative ventures better and faster, in turn bringing solutions to market and to patients more quickly.
A Collaborative Transformation Perspective on Digital Health
Healthcare is facing an age of disruption from new players and new market entrants from outside the traditional healthcare paradigm. These disruptors have varying degrees of experience in the highly regulated and closely scrutinized healthcare landscape. How can these parties work together across different cultures and regulatory environments…
A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National Coordinator for Health Information Technology’s (ONC’s) final rule, entitled 21st Century Cures Act: Interoperability, Information Blocking, and the ONC…
The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several…
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software applications and other transformative technologies, such as artificial intelligence and 3D printing, are reshaping how medical devices are developed, and FDA is seeking to align its mission and regulatory obligations with those changes.
FDA’s digital health software precertification program is a prime example of this approach. Once fully implemented, this voluntary program should expedite the path to market for software as a medical device (SaMD), and promote greater transparency between FDA and regulated entities.
Under the program, FDA will conduct a holistic review of the company producing the SaMD, taking into account aspects such as management culture, quality systems and cybersecurity protocols, to ascertain whether the company has developed sufficient infrastructure to ensure that its products will comply with FDA requirements and function safely as intended. Companies that fulfill the requirements of the excellence appraisal and related reviews will receive precertification that may provide for faster premarket reviews and more flexible approaches to data submissions at the outset.
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,” announcing steps to consider a new regulatory framework to promote the development of safe and effective medical devices that use advanced AI algorithms. AI, and specifically ML, are “techniques used to design and train software algorithms to learn from and act on data.” FDA’s proposed approach would allow modifications to algorithms to be made from real-world learning and adaptation that accommodates the iterative nature of AI products while ensuring FDA’s standards for safety and effectiveness are maintained.
Under the existing framework, a premarket submission (i.e., a 510(k)) would be required if the AI/ML software modification significantly affects device performance or the device’s safety and effectiveness; the modification is to the device’s intended use; or the modification introduces a major change to the software as a medical device (SaMD) algorithm. In the case of a PMA-approved SaMD, a PMA supplement would be required for changes that affect safety or effectiveness. FDA noted that adaptive AI/ML technologies require a new total product lifecycle (TPLC) regulatory approach and focuses on three types of modifications to AI/ML-based SaMD:
As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program.
There are two criteria for inclusion in the Breakthrough Device Program:
- The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and
- The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients.
The digital health market is expected to grow beyond $379 billion by 2024, with a 27.7 percent compounded annual growth rate over the coming years. This activity is fueled by increasing demand for remote monitoring services, favorable government initiatives and funding, and the proliferation of mobile intelligent devices. An article by Rock Health noted that in 2018, “investors poured nearly $8.1B into the sector, surpassing 2017’s record-setting total of $5.7B by a whopping 42%.”
Amidst this growth, digital health startups are seeking to make the most of their funding and protect the innovations that drive their product. To do so, they must protect their intellectual property from being copied or duplicated by others in the market. Patents offer the strongest form of protection for innovations and can lead directly lead to increased investment. For digital health startups that eventually go public, valuation can reach $1.1 million per software patent application filed.
An issued patent in the United States gives the patent owner a 20-year monopoly right to stop others from making, using or selling the patented invention. A digital health company with a patent on a software feature—for example, a unique approach to dynamically generate a questionnaire based on user information for a remote health consult—has the right to stop competitors from making, selling or using software that includes that feature. Digital health companies, particularly pre-IPO, should develop a patenting strategy to assess how best to protect the innovations that drive their business and increase the company’s monetary value and longevity. If you have ever said one of the following phrases, your company likely will benefit from a discussion with patent counsel on how to protect your inventions:
- We’re the first ones to ever do this.
- None of our competition does this.
- This feature drives a lot of business to our company.
- This feature was really hard to implement, but we found a way to do it.
We greatly appreciate our readers continuing to turn to us for insight on the most critical legal, regulatory and transactional developments impacting digital health, and the innovative collaborations transforming health care. Over the past year, McDermott’s Health practice made headlines for our work on several of the most high-profile collaborative transformations that took place in…