Digital Health

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Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with lawyers who understand how the regulatory, IP, and commercial pieces of the digital health puzzle fit together is essential. The Digital Health team offers unsurpassed breadth and depth of expertise and experience concerning the legal, regulatory, and policy issues that affect digital health products and services.

Regulatory. We help clients navigate the myriad regulatory issues posed by digital health technologies and services, including regulatory classification of software, devices, and combination products; drug regulatory issues implicated by digital health products that are associated with pharmaceuticals or developed by or in collaboration with drug manufacturers; the application of market access rules; the regulation of healthcare and e-commerce services; wireless device regulation; and pricing and reimbursement. Our life sciences and technology teams are consistently recognized as premier practices by leading legal directories such as Chambers and Legal 500.
Technology Transactions. Our technology transactions team has been at the cutting edge of cloud services and big data transactions, collaborating with clients efficiently and effectively to craft transactions that meet their business objectives and address the regulatory issues raised by greater industry-wide reliance on the cloud and big data. We also provide strategic and legal advice in structuring and negotiating all types of ICT agreements, including software licensing, support and maintenance, software and hardware development, SaaS agreements, and system procurement. We have extensive experience in related transactions, such as joint ventures, collaborations, and outsourcing arrangements as well as all aspects of social media and mobile commerce.
Privacy and Data Security. Covington’s leading, global privacy and data security team has been at the forefront of privacy and security issues affecting life sciences, information technology, e-commerce and social media companies for decades. We are highly experienced in dealing with the privacy and security laws, regulations and guidance that govern the data collection, processing and usage at the heart of digital health solutions.
Intellectual Property. Our IP lawyers can advise digital health stakeholders on the full range of IP issues, including the procurement, commercialization, defense, and enforcement of patent, trade secret, copyright, design and other IP rights in software, hardware and collections of data.
Product Liability. Digital health products and services may, by reason of defective hardware or software, or incorrect input data, result in harm being caused to their users and recipients. Covington has a dynamic product liability practice, regularly serving as defense trial and appellate counsel in product liability and mass tort lawsuits, and as strategic advisors for clients with liability risks or actions.
Government Contracts. Government purchasers are poised to be one of the largest consumers of digital health services. Covington’s government contracts practice is well situated to advise contractors who wish to compete to provide these services to government, advise on government grants for the use of electronic health record technology, and assist with corporate transactions involving divisions that are recipients of government grants or contracts.
Antitrust/Competition. Ranked among the top antitrust and competition firms in the world, Covington can guide clients through the maze of antitrust and competition considerations raised by the access, interoperability, compatibility, exclusivity and other issues raised by in digital health platforms, apps and transactions. Our team understands the need for a holistic approach that manages these issues in the context of the overall business goals of the project.
Public Policy. With technological developments outpacing the adoption of rules and regulations, governments around the world continue to address the need for policies and standards for digital health technologies. Our international Public Policy team includes professionals with established credentials in health and information technology policies and relationships with key governmental decision makers. We have experience guiding the drafting of legislation in the United States, Europe and elsewhere to ensure that it lends itself to regulatory implementation and advances industry goals, and we effectively manage regulatory and policy processes to advance our clients’ business objectives.

Our attorneys in these and other related practice areas collaborate seamlessly across practices, offices, and jurisdictions to develop creative and practical solutions for digital health products, solutions and services. We have represented a variety of different players in the digital health ecosystem, enabling us to understand the issues and imperatives of clients filling a variety of roles. As a result, we are well placed to advise our clients on what to expect, given current market trends and typical resolutions, and likely future developments. By coordinating across our offices in the United States, Europe, and Asia, we are able to advise clients on a global basis.

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New Report Recommends Putting Public Engagement at the Heart of NHS Health Data Strategy

The Institute of Global Health Innovation at Imperial College London has published a report called “NHS data: Maximising its impact on the health and wealth of the United Kingdom” (the “Report”).[1] The Report begins from the premise that the knowledge gleaned from the combination of patient health data and “big data” technologies has incredible potential...… ...

Germany Publishes Draft Regulation on the Reimbursement of Digital Health Applications

Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps. Accordingly, on January 15, 2020, the German government published a draft regulation ...

European Parliament Endorses Digital Health Resolution

On December 12, 2019, the European Parliament endorsed a non-binding resolution on enabling the digital transformation of health and care. The resolution calls on the European Commission to take a number of actions to foster the development of digital health systems in Europe to improve patient care and support research efforts — particularly those using...… ...

Digital Healthcare Act Takes Effect in Germany

Digital health applications that meet certain requirements will be covered by the German state health insurance schemes from 2020. This is one of the elements of the Digital Healthcare Act 2019 (Digitale Versorgung-Gesetz), which we discussed in an earlier post this year and which was approved by the German Parliament in November and published on...… Continue ...

Lawyers, Ask These 10 Questions During Digital Health Ideation

Covington has created a list of Top 10 Questions for Ideation of Digital Health Solutions that can help lawyers contribute to the digital health ideation process. Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. "Ideation" is part of that process and involves the rapid ...

UK ICO and The Alan Turing Institute Issue Draft Guidance on Explaining Decisions Made by AI

The UK’s Information Commissioner’s Office (“ICO”) has issued and is consulting on draft guidance about explaining decisions made by AI. The ICO prepared the guidance with The Alan Turing Institute, which is the UK’s national institute for data science and artificial intelligence. Among other things, the guidance sets out key principles to follow and steps to ...

Ideation Question #8: What is Novel in the Digital Health Solution and What Will Give the Solution a Competitive Advantage?

This is the eighth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what is novel in the digital health solution and what will give the solution a competitive advantage?… Continue Reading

Ideation Question #7: Are Healthcare Providers Involved, and What Questions Should Be Considered for Collaborations?

This is the seventh of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: are healthcare providers involved, and what questions should be considered for collaborations?… Continue Reading

Covington Advises Sensyne Health on Collaboration with Jefferson Health

NEW YORK—Covington has advised Sensyne Health, the British clinical AI technology company, on its agreement with Jefferson Health to evaluate the clinical and commercial potential of its GDm-Health™ system in the United States. GDm-Health is a direct patient-to-clinician blood glucose monitoring management system specifically designed for the management of ...

US official highlights role of encryption in hacking scheme

Trisha Anderson is quoted in Global Data Review regarding cyber and ransomware attacks. Ms. Anderson said that while the use of technologies like Tor and Bitcoin pose challenges to law enforcement by “raising the level of investigative effort and sophistication required to identify and locate cyber criminals,” the indictment in the SamSam Ransomware cyberattacks ...

China issues rules on e-health care delivery

Christopher Chen spoke with BioWorld MedTech regarding China’s move to regulate e-health care services. Mr. Chen says, “The rules make open channels for other e-health care collaborations. Med-tech companies and private health care companies may be able to participate in health care practice as a collaborator in an e-hospital. The promulgation of these rules ...

Covington Advises Ziylo on Acquisition by Novo Nordisk

LONDON—Covington has advised Ziylo on its acquisition by Novo Nordisk with a potential deal value that could exceed $800 million. Ziylo, a University of Bristol spin-out company based at the Unit DX science incubator, is a supramolecular chemistry company that has developed a third 'biomimetic' class of glucose binding molecules. The acquisition gives Novo ...

Covington Advises Sensyne Health on IPO and Pioneering Strategic Agreements

LONDON—Covington has advised Sensyne Health on medical device regulatory and data protection matters in connection with its £60 million IPO on London’s AIM market. The firm also represented Sensyne Health in negotiating strategic research and data processing agreements with the Chelsea and Westminster Hospital NHS Foundation Trust, the Oxford University ...

US FDA's Software Pre-Cert Program: Is The Authority On The Books?

Wade Ackerman is quoted in Medtech Insight regarding the FDA’s software pre-certification program and what that means for device and digital health firms interested in getting new products to the market. Mr. Ackerman says, "The agency has been transparent in that it is considering various legal mechanisms available to the agency to establish the program – ...

Covington Advises GSK on 23andMe Collaboration and $300M Investment

SILICON VALLEY—Covington advised GlaxoSmithKline on its multi-year collaboration with and $300 million equity investment in 23andMe. GSK will become 23andMe’s exclusive collaborator for drug target discovery programs. The collaboration will focus on research and development of innovative new medicines and potential cures using human genetics as the basis for ...

How Can We Make Best Use of Health Data?

Kristof Van Quathem participated in a Financial Times podcast to discuss the impact of the General Data Protection Regulation on medical research and health technology companies. According to Van Quathem, "One of the main concerns I think that we see in the research circle is the uncertainty that is being created by the GDPR, and in particular, when it comes to ...

Covington Nabs Veteran Tech Dealmaker From Wilson Sonsini

The Recorder highlights the arrival of Suzanne Bell to Covington's Technology Transactions practice. Bell says she was attracted to the firm's strong regulatory practice given the increased intersection between the technology sector and government regulations. Bell adds that she is looking forward to using her experience in technology transactions to assist ...

CQC report on online primary health services shows progress

Brian Kelly and Raj Gathani are quoted in a Digital Health Legal article regarding a report published by the UK’s Care Quality Commission on "The state of care in independent online primary health services." According to Kelly and Gathani, “The report illustrates some of the teething problems in the inspection system, particularly when applied to online ...

Wade Ackerman and Aaron Lewis Named Among LA's Most Influential Diverse Lawyers

LOS ANGELES—The Los Angeles Business Journal recognized Wade Ackerman and Aaron Lewis in its second annual list of the most influential diverse lawyers in Los Angeles. The list recognizes 50 "stellar diverse lawyers in the LA region." In Mr. Ackerman’s profile, the Business Journal emphasized his work in the FDA regulatory space. The profile noted that “with a ...

DoH expands CQC healthcare quality rating powers

Raj Gathani is quoted in a Digital Health Legal article regarding the UK Department of Health's decision to expand the Care Quality Commission's (CQC) quality rating powers. “In a sense, the announcement simply corrects an imbalance between NHS and private providers,” says Gathani. “The announcement comes after a year in which online doctor services have come ...

Miranda Cole Named Among Politico's "Women Who Shape Brussels"

BRUSSELS—Politico has named Covington partner Miranda Cole to its “2017 Women Who Shape Brussels” list, a group of “20 powerhouses driving debates and influencing policy in 2017.” In its profile of Ms. Cole, the publication highlights her defense of leading technology clients, including Microsoft, Facebook, and Verizon, before the European Commission. Politico ...

Is there a robot doctor in the house?

Lindsey Tonsager is quoted by The Times in an article regarding the use of artificial intelligence in healthcare. Commenting on how regulators are beginning to address some of the issues, Tonsager says, "The law hasn’t caught up with the technology. Nobody knows exactly who will be responsible.” “Some diseases disproportionately affect certain types of ...

Cyber Insurance Offerings Growing In Response To New Threats

Marialuisa Gallozzi, John Buchanan, and Jeff Kiburtz are quoted in a Medtech Insight article regarding the growing interest in the healthcare sector in buying cyber insurance. According to Gallozzi, "We are in the midst of an evolution of the insurance market right now in this area." She says cyber insurance policies have been a growing trend but unlike other ...

U.S. FDA's New Game Plan For Digital Health

Wade Ackerman is quoted in a Medtech Insight article regarding FDA's regulatory strategy in relation to digital health. "While Congress addressed some aspects of FDA's regulation of health software in the 21st Century Cures Act last year, the digital landscape continues to evolve rapidly," Ackerman says. "FDA's intent to outline a new digital health innovation ...

FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More

Wade Ackerman is quoted by MedTech Insight in an article covering the May 5 Food, Drug and Law Institute's annual meeting in Washington. Ackerman provided his insights on the hiring trajectory for those individuals tasked to implement the 21st Century Cures Act, and noted that the funds can be viewed as having broad applications for hiring. Ackerman stated, ...

CMS Finalizes Market Stabilization Rule

Last Thursday, the Centers for Medicare & Medicaid Services (CMS) finalized the Affordable Care Act (ACA) market stabilization rule, which it originally proposed in February, 82 Fed. Reg. 10,980 (Feb. 17, 2017). This final rule was published today in the Federal Register and will become effective on June 19, 2017. 82 Fed. Reg. 18,346. The final rule includes ...