Covington Digital Health Team

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. To learn more, click here.

Digital health record

On March 4, 2019, the Department of Health and Human Services (HHS) published two proposed rules to improve patient access to personal health data. The two rules, issued by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC),
Continue Reading Patient Access to Electronic Health Data at the Forefront of Two HHS Proposed Rules

Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases allow healthcare professionals to follow-up on the condition or habits of their patients, often in real-time. How do manufacturers determine what wearables qualify as medical devices? How do they assess whether their devices need a CE-mark? Must they differentiate between the actual “wearable” and the hardware or software that accompanies them? In this short contribution, we briefly analyze some of these questions. The article first examines what “wearables” are, and when they qualify as a medical device under current and future EU rules. It then addresses the relevance of the applicability of EU medical devices rules to these products. The application of these rules is often complex and highly fact-specific.
Continue Reading Are Wearables Medical Devices Requiring a CE-Mark in the EU?

On 20 November 2018, the UK government published its response (the “Response”) to the June 2018 consultation (the “Consultation”) regarding the proposed new Centre for Data Ethics and Innovation (“DEI”). First announced in the UK Chancellor’s Autumn 2017 Budget, the DEI will identify measures needed to strengthen the way data and AI are used and regulated, advising on addressing potential gaps in regulation and outlining best practices in the area. The DEI is described as being the first of its kind globally, and represents an opportunity for the UK to take the lead the debate on how data is regulated.
Continue Reading IoT Update: The UK Government’s Response to Centre for Data Ethics and Innovation Consultation

The Centers for Medicare & Medicaid Services (CMS) recently announced that Medicare coverage policies would be revised “to support the use of [continuous glucose monitors] in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.” In turn, the agency’s contractors, known as
Continue Reading Medicare Policies Modified to Support Smart Devices Use for Sharing Glucose Data

Earlier this year, President Trump signed into law the Bipartisan Budget Act of 2018 (BBA), which incorporates provisions from the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 and improves access to telehealth services in Medicare Advantage. Pub. L. No. 115-123. Among other provisions impacting Medicare Advantage Organizations (MAOs), the BBA authorizes MAOs to offer additional telehealth benefits as basic benefits beyond original Medicare (Part A and Part B) limitations. Id. at Div. E., Title III, Subtitle C, § 50323.
Continue Reading Medicare Advantage Organizations Provided New Opportunities to Offer Telehealth Benefits

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

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 opportunities to risks and challenges. In addition to scoping the legal and regulatory landscape, the Report considers the role of AI in a social and economic context, and proposes a set of ethical guidelines. This blog post sets out those ethical guidelines and summarises some of the key features of the Report.
Continue Reading Covington Artificial Intelligence Update: House of Lords Select Committee publishes report on the future of AI in the UK

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 of a button, with easy access to their entire medical history from birth, including data from health visits, claims, and information gathered through wearable technology.

According to Administrator Verma’s speech and a CMS announcement, the MyHealthEData program is a government-wide initiative that includes the following components:Continue Reading CMS Announces MyHealthEData Initiative to Promote Patient Access to Health Data

Digital HealthInflection 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
Continue Reading Latest NIST Draft Report a Call to Action for Federal Agencies and Private Companies