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- Digital Health
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.
October 19, 2020, Covington Digital Health
On September 30, 2020, the Cybersecurity and Infrastructure Security Agency (“CISA”) and the Multi-State Information Sharing and Analysis Center (“MS-ISAC”) released a joint guide synthesizing best practices to prevent and respond to ransomware. This guide was published the day before OFAC and FinCEN released their coordinated guidance on ransomware attacks ...
October 16, 2020, Covington Digital Health
California Attorney General Xavier Becerra (“AG”) announced in September a settlement against Glow, Inc., resolving allegations that the fertility app had “expose[d] millions of women’s personal and medical information.” In the complaint, the AG alleged violations of certain state consumer protection and privacy laws, stemming from privacy and security ...
October 6, 2020, Covington Digital Health
In this edition of our regular roundup on legislative initiatives related to artificial intelligence (AI), cybersecurity, the Internet of Things (IoT), and connected and autonomous vehicles (CAVs), we focus on key developments in the European Union (EU). There has been some policy activity in the U.S. this quarter, including the re-introduction of the SELF-DRIVE ...
HHS Announces Multiple HIPAA Settlements Related to Data Breaches and the Right of Access Initiative
October 6, 2020, Covington Digital Health
Throughout September, the Department of Health and Human Services, Office for Civil Rights (“OCR”), announced eight different settlements to resolve a variety of alleged violations of the Privacy and Security Rules promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Notably, three settlements stem from data breaches in ...
September 28, 2020, Covington Digital Health
In a new post on the Covington Inside Privacy blog, our colleagues discuss the passage of California’s AB 713, a bill that creates a new healthcare-related exemption under the California Consumer Privacy Act of 2018 (“CCPA”) for certain information that has been deidentified in accordance with the Health Insurance Portability and Accountability Act of 1996...… ...
HHS Launches New “Health Apps” Website to Highlight HIPAA Guidance for Mobile Health Applications
September 16, 2020, Covington Digital Health
On September 2, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a new “Health Apps” feature on the HHS.gov website. The new website, which replaces the OCR’s Health App Developer Portal, highlights existing guidance for mobile health (“mHealth”) apps regarding the Health Insurance Portability and Accountability ...
September 8, 2020, Covington Digital Health
The FTC has recently provided new guidance on the use of AI and algorithms, including a blog post that focuses on the benefits and risks of AI in the “Health AI” space. Former FTC Commissioner Terrell McSweeny, AI Initiative Co-Chair Lee Tiedrich, and Jadzia Pierce discuss the post, along with other AI-focused guidance from the...… Continue Reading
August 21, 2020, Covington Digital Health
The National Institute of Standards and Technology (“NIST”) is seeking comments on the first draft of the Four Principles of Explainable Artificial Intelligence (NISTIR 8312), a white paper that seeks to define the principles that capture the fundamental properties of explainable AI systems. NIST will be accepting comments until October 15, 2020. In February ...
August 18, 2020, Covington Digital Health
On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software. The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which ...
August 18, 2020, Covington Digital Health
On July 30, 2020, the UK Information Commissioner’s Office (“ICO”) published its final guidance on Artificial Intelligence (the “Guidance”). The Guidance sets out a framework for auditing AI systems for compliance with data protection obligations under the GDPR and the UK Data Protection Act 2018. The Guidance builds on the ICO’s earlier commitment to enable ...
March 19, 2020, BioTech
Scott Danzis spoke with BioWorld about the uptick in coronavirus testing by the FDA and CDC. Mr. Danzis says that while the FDA and the CDC struggled to move testing forward in the early days, “things have shifted dramatically” since that time. He adds that the issue of FDA regulation of lab-developed tests is of long standing, but that the Verifying ...
October 2020
Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are ...
January 2020
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 ...
November 25, 2019, Westlaw Journal Medical Devices
February 6, 2019
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 ...
November 30, 2018, Global Data Review
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 ...
October/November 2018, Update (reprinted with permission from FDLI)
Covington Advises Ziylo on Acquisition by Novo Nordisk
August 23, 2018
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 ...
August 17, 2018
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 ...
July 31, 2018, Medtech Insight
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 – ...
July 30, 2018
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?
June 14, 2018, Financial Times
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 ...
April 12, 2018, The Recorder
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 ...
April 2018, Digital Health Legal
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 ...
February 6, 2018
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
January 2018, Digital Health Legal
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 ...
November 10, 2017
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?
October 29, 2017, The Times
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 ...
October 2017, Digital Health Legal
July 28, 2017, Medtech Insight
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
June 16, 2017, Medtech Insight
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 ...
May 9, 2017, MedTech Insight
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, ...
April 18, 2017, Covington Alert
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 ...
Legislative Initiatives: Hot Topics in Health Care
December 13, 2016, PLI's Health Care Law Institute 2016
Legislative Initiatives: Hot Topics in Health Care
December 2015, PLI's Health Care Law Institute 2015
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Covington Digital Health Blog
Top 10 Questions During Ideation of Digital Health Solutions
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.
Digital Health Blog
Get fresh legal insights from our cross-disciplinary Digital Health team across the full spectrum of issues implicated by digital health.