In our global economy, Coronavirus (COVID-19) raises serious concerns for employers in all industries. Workers may be on the front lines caring for patients and developing vaccines, travelling for business, or in close contact with individuals who travel or may have been affected. At this time, there is no vaccine or medication approved to prevent
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.
Digital health is experiencing a boom in investment as the regulatory environment becomes more supportive of digital health services. But as companies seek to make the most of their funding and protect the innovations that drive their product, it is imperative that they protect their intellectual property from being copied or duplicated by others in the market.
What exactly is IP?
Intellectual Property (IP) is generally non-tangible property. You can hold your laptop in your hands or you can stand on a piece of land — those are both tangible examples of property. Intellectual property cannot be physically held or touched. Protections available for intellectual property generally break down into one of four areas: patents; trade secrets, trademark, and copyright.
Patent protection offers an additional layer of protection for digital health solutions compared to copyrights. For example, a company may be eligible for a patent if it has innovated a new approach to identifying data, a new approach to storing data more efficiently, or a new approach to the data structure itself—those are all ways where innovations could be patentable and help extend protection around data.
How does IP apply to data?
If, in a digital health patent application, a company focuses on innovation for a computer-specific problem—such as keeping data private, keeping data secure, de-identifying data—that is usually a homerun argument to the patent office for crossing the first threshold of eligibility for patenting.
This is one of the few areas where the patent office has made it clear that these ideas and invention types are considered patent eligible. Thereafter, of course, remains the traditional challenge of getting a patent, which is to prove that no one before you has invented what you’ve invented. But lately, in the digital health space, that challenge seems to be less difficult to overcome compared to the eligibility challenge.
How to protect IP
Digital health companies are producing innovative products at a rapidly accelerating pace and experiencing a boom in investments and demand as the regulatory environment becomes more supportive of digital health services to both improve patient care and stay profitable. Protecting intellectual property (IP) and building a feasible data strategy to support the research and development…
When it comes to market success for digital tools in the health sector, business strategy can be far more complex than in other industries. Understanding customer-driven market trends is important, but healthcare’s complexity can camouflage customer demand and its regulatory ecosystem adds layers of additional considerations.
Customer Demand and Digital Solutions
The convenience, competitive pricing, answers-at-your-fingertips responsiveness and hyper-personalization delivered by top technology brands and their integration into other industry sectors has created an expectation for digital health solutions that deliver the same experience.
In some instances, consumers are finding the solutions. For example, telemedicine is gaining momentum as consumers discover that digital interactions with high-quality providers are oftentimes more convenient and less expensive than face-to-face encounters. Other tools are providing access to prescriptions, better health condition management solutions, better information sharing enabling smoother transitions among care settings, and more efficiency in everything from hospital operations to scheduling appointments to identifying in-network care options.
When it comes to business strategy, however, digital health solutions need to recognize that consumer pressures are frequently at odds with existing incentives within care delivery systems and, perhaps legal and regulatory requirements. Accordingly, it is critical not just from a compliance perspective but also from a business strategy perspective to navigate the healthcare industry’s unique market and regulatory dynamics.
Balancing Demand with Reality
The digital health space had a strong start to 2020 with two of the industry’s largest conferences leading the conversation on what’s to come for digital health companies, deals, products and the regulatory outlook in the coming year. The Consumer Electronics Show (CES) launched its Digital Health programming track in Las Vegas this year and…
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…