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. Covington 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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Summary of the CPS Paper on the Integration of Technology in the UK’s National Health Service

On 1 May, 2018 the Centre for Policy Studies (the “CPS”) published its latest paper on the UK’s National Health Service (the “NHS”) entitled “Powerful Patients, Paperless Systems: How New Technology Can Renew The NHS” (the “Paper”). The Paper advocates a “digital first NHS” that adopts a paperless system and enables patients to take full...… Continue Reading

Inside FDA’s Latest Digital Health Developments: Gottlieb Sees “Vast Potential” Ahead

On April 26, Commissioner Gottlieb addressed the agency’s progress on FDA’s Digital Health Innovation Action Plan and announced several additional steps the agency is taking to advance the potential benefits of digital health. Here is a recap of the key updates: (1) Launch of New FDA Program to Apply Digital Health to Drugs As our...… Continue Reading

Summary of the European Commission’s eHealth Strategy

On the April 25, 2018 the European Commission (the “Commission”) adopted a plan of action to enable the digital transformation of health and care in the Digital Single Market (the “Communication”), intended to put EU citizens at the centre of the healthcare system. This is to be achieved in three ways: 1. Citizens’ secure access...… Continue Reading

Covington Artificial Intelligence Update: House of Lords Select Committee publishes report on the future of AI in the UK

Reflecting evidence from 280 witnesses from the government, academia and industry, and nine months of investigation, the UK House of Lords Select Committee on Artificial Intelligence published its report “AI in the UK: ready, willing and able?” on April 16, 2018 (the Report). The Report considers the future of AI in the UK, from perceived...… Continue Reading

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 ...

CMS Announces MyHealthEData Initiative to Promote Patient Access to Health Data

On March 6, 2018, CMS announced the MyHealthEData initiative, which aims to give patients easier access to and control over their medical records. Announcing the initiative, CMS Administrator Seema Verma laid out a future where individuals will have access to their health data wherever they go and be able to share data with the push...… Continue Reading

Latest NIST Draft Report a Call to Action for Federal Agencies and Private Companies

Inflection Point for IoT In a relatively short amount of time, the adoption of the Internet of Things (IoT) and its applications— from smart cars to the myriad of interconnected sensors in the General Service Administration building reminiscent of HAL 9000 from 2001: A Space Odyssey— has rapidly proliferated, providing significant opportunities and benefits. ...

Three EHR Issues to Watch in 2018

As 2018 gets underway, EHR vendors and users continue to face challenges and uncertainty. There are three legal and regulatory issues in particular that we think are important to watch over the next 10 months: Moving to the 2015 Edition Certification Criteria. Although CMS will not require hospitals or eligible professionals to use 2015 CEHRT...… Continue ...

Key Takeaways from Covington’s Webinar about Digital Health Associated with Pharmaceuticals

On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar: Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company...… Continue ...

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 ...

Open Source Considerations for Digital Health Ventures

Technology companies widely use open source software (“OSS”), which carries with it many potential benefits. It can reduce the time and cost of development, and, to the extent that the code has been vetted by numerous other developers, may contain fewer bugs. OSS can also reduce dependency upon third party vendors and associated pricing risks....… Continue ...

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 ...

FDA Outlines Updated Approach to Regulating Digital Health Technologies

On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...

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 ...