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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. 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 and Government Affairs. 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 and Government Affairs 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.
September 5, 2017, Covington Digital Health
On August 30, the UK government published a report by Professor Sir John Bell of Oxford University providing a number of recommendations to government to ensure the long term success of the life sciences sector in the UK (Life Sciences Industry Strategy). This blog post summarises the key recommendations and observations made from a digital...… Continue Reading
August 29, 2017, Covington Digital Health
In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Regulatory Questions About Digital Health ...
August 25, 2017, Covington Digital Health
At the beginning of August, the D.C. Circuit found that the fact that a data breach has occurred and individual consumer information has been lost may constitute sufficient injury to confer standing on those individual victims at the pleading stage–irrespective of whether any stolen information has been misused. Specifically, Attias, et al. v. CareFirst, ...
August 9, 2017, Covington Digital Health
On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software ...
August 3, 2017, Covington Digital Health
On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice. The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan. CDRH also held a webinar on August 1 to provide an overview of the program and answer...… Continue ...
August 3, 2017, Covington Digital Health
On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month. The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and ...
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 ...
July 26, 2017, Covington Digital Health
Digital health solution providers, and users of digital health services, should take note of three recently launched EU public consultations in the digital health space, and may wish to make submissions to help shape the future of digital health initiatives in the EU. The earliest deadline for submissions is 16 August 2017. EU Commission Transformation...… ...
July 4, 2017, Covington Digital Health
The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to sign ...
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 31, 2017, Covington Digital Health
On May 11, 2017, the European Cloud in Health Advisory Council (ECHAC) – a group of healthcare organizations, technology companies and patient representatives – launched its second whitepaper focused on use of data to improve health outcomes and delivery of care. ECHAC launched the whitepaper at an eHealth Week 2017 session attended by ECHAC participants ...
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 ...
April 7, 2017, Covington Digital Health
Last week, Senators Cory Gardner (R-CO) and Gary Peters (D-MI) introduced new legislation to test expanded Medicare coverage of telehealth services. The Telehealth Innovation and Improvement Act requires the Department of Health and Human Services (HHS) to allow selected, eligible hospitals to offer telehealth services in cooperation with the Center for ...
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Covington Digital Health Blog
Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One)
August 29, 2017In the first of a three-part series, our global cross-practice Digital Health team answers key questions...