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Future Forward: Data Arrangements During and After COVID-19

The need for speedy and more complete access to data is instrumental for healthcare providers, researchers, pharmaceutical, biotech and device companies and public health authorities as they work to quickly identify infection rates, disease trends, outcomes, including antibodies, and opportunities for treatments and vaccines for COVID-19. A variety of data sharing and collaborations have emerged in the wake of this crisis, such as: Requests and mandates by public health authorities, either directly or via providers’ business associates requesting real time information on infections and bed and equipment availability Data sharing collaborations among providers for planning, anticipating and tracking COVID-19 caseloads Data sharing among providers, professional societies and pharmaceutical, biotech and medical device companies in search of testing options, treatment and vaccine solutions, and evaluation of co-morbidities CLICK HERE TO VIEW THE FULL...

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Bipartisan Bill Relaxes Federal Telehealth Requirements in the Wake of COVID-19

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 to avoid placing themselves at greater risk of the virus. Generally, Medicare beneficiaries may only receive telehealth services as a Medicare covered service if: The beneficiary (patient) is located in a qualifying rural area; The beneficiary is located at one of eight types of qualifying originating sites; The services are provided by one of 10 categories of distant site practitioners eligible to furnish and receive Medicare payment for telehealth services; The beneficiary and distant site practitioner communicate via an interactive audio and video telecommunications system...

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The Role of Telehealth in COVID-19 Response Efforts

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 use of telehealth tools to help address COVID-19 preparedness and to assist in directing patients to the right level of healthcare for their medical needs. Healthcare providers have a unique and pressing opportunity to offer telehealth services to potential COVID-19 patients. At the same time, healthcare providers’ response to the COVID-19 outbreak highlights some of the barriers to the provision of telehealth services. Providers considering using telehealth as part of their COVID-19 response efforts should take the following factors into consideration: While healthcare providers cannot diagnose COVID-19...

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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...

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Maximizing Your IP Protections in Digital Health

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...

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New Podcast | Protecting Your Tech: IP Considerations in Digital Health

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 endeavor are essential steps for companies in their drive toward commercialization and return on their investment. On this episode of the Of Digital Interest podcast, McDermott partners Bernadette Broccolo (Health) and Ahsan Shaikh (IP), explore key issues for digital health companies, their collaboration partners and investors, and start-ups to consider, including: What is currently patent eligible in the digital health space? What patent-eligible trends and opportunities are we seeing? How do laws governing data sharing among digital health collaborators impact the research and...

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Digital Health Business Strategy: A Careful Balance

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...

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New Podcast | 2020 Digital Health Outlook: Thoughts from CES and JPM

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 the J.P. Morgan Healthcare Conference continued to bring thousands of healthcare investors from numerous sectors together in San Francisco. On this episode of the Of Digital Interest podcast, McDermott partners Sarah Hogan and Dale Van Demark share their takeaways from the conferences, where they were on the ground and moderating discussions. This episode explores: The role of digital therapeutics in the digital health marketplace The role of the consumer in digital health adoption Forward-looking thoughts on digital health collaborations The importance of data, privacy and trust for the future of digital health solutions...

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Available Now – 2019 Digital Health Year in Review

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 patients and consumers and encourage continued innovation, but these efforts still lag behind the pace of digital health innovation. As a result, some obstacles, misalignment and ambiguity remain, and 2020 will likely be another year of significant legal and regulatory change. Click here to read our review of key developments that shaped digital health in 2019 and set the groundwork for trends in 2020.  

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Digital Health in the UK: The New Regulatory Environment Under the Medical Device Regulation

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...

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