On March 4, 2020, the House passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, a bipartisan bill to aid in COVID-19 preparedness and response. The bill includes, among other things, provisions that waive certain telehealth requirements during the COVID-19 public health emergency to ensure Medicare beneficiaries can receive telehealth services at home

As the number of confirmed COVID-19 cases in the United States grows, healthcare providers are stepping up their response planning. To combat the spread of COVID-19, the Centers for Disease Control and Prevention (CDC) urged healthcare systems and providers to deploy all of the resources necessary to ensure health system preparedness. The CDC recommended the

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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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


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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

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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

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long Term Plan, which set out ambitious aims for the acceleration and adoption of digital health and AI, particularly in primary care, outpatients and wearable devices.

Although these developments are encouraging to developers, there is still no clear framework for reimbursement or tariffs for digital health tools and AI.

At the same time, the plethora of new technologies has led to increased calls for regulation and oversight, particularly around data quality and evaluation. Many of these concerns may be addressed by the new Medical Device Regulation (MDR) and other regulatory developments. In fact, there is some risk that while regulatory landscape is moving quickly, the pricing environment is still a way behind.

In May 2020, the new MDR will change the law and process of certification for medical software. The new law includes significant changes for digital health technologies which are medical devices. In March 2019, the National Institute for Health and Care Excellence (NICE) also published a new evidence standards framework for digital health technologies. The Care Quality Commission (CQC) already regulates online provision of health care, and there are calls for wider and greater regulation. The government has also published a code on the use of data in AI.

Digital Health Technologies and the MDR

The new MDR will mean a significant change to the regulatory framework for medical devices in the European Union.

As with the previous law, the MDR regulates devices through a classification system.

The new regime introduces new rules for medical software that falls within the definition of device. This will mean significant changes for companies that develop or offer medical software solutions, especially if their current certification has been “up-classed” under the MDR.

Key Takeaways for Investors in Digital Health Tools

Companies and investors in digital health should:

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The interest in leveraging the value of big data in digital health has become a focus of health care industry mainstays and newcomers alike. Within a challenging regulatory landscape, it is critical for those looking to play in this space to be proactive in planning their data strategy, with an eye towards compliance planning and solid due diligence to maximize its value. In this Q&A, big data thought leaders Bernadette Broccolo and Sarah Hogan, both partners in McDermott Will & Emery’s Health Industry Advisory group, discuss the challenges and opportunities that health industry stakeholders face when stepping into the world of big data.

For information on this topic and to hear the full Q&A with Bernadette and Sarah, listen to the newest episode of the Of Digital Interest podcast. You can access the full episode at here or subscribe to the podcast on iTunesPocket Casts or Soundcloud.

Q. Where is the value in big data in digital health? Who is seeing value today and what are their motivations?

BB: The best short answer is that everybody is seeing value – both long standing industry players and newcomers. The real value in big data comes not from raw data or just having a lot of data, but in the ability to use it and mine it, to have it in a form that’s analyzable. What’s very surprising too, in addition to the speed with which the interest in big data has escalated, is who is interested. In the past, one certainly expected academic medical centers and universities that have major research initiatives and clinical trial initiatives to be interested. But now others like molecular lab testing organizations, CLIA regulated laboratories and entrepreneurs are interested in capturing data.

SH: I think one of the surprising players is actually the pharma companies. It may sound odd to say that, but they have a lot of data – including a lot of clinical data – that they’re looking at mining to determine how they can target their therapeutics in a way that helps patients more efficiently. They are looking at themselves and asking “What does the 21st century pharma company look like?”
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