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.

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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

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. However, … Continue Reading

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 Reading

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 guidances announce the … Continue Reading

Digital Health Checkup (Bonus): Product Liability and Insurance Coverage

In this bonus edition of our checkup series, Covington’s global cross-practice Digital Health team considers some additional key questions about product liability and insurance coverage that companies across the life sciences and technology sectors should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. 1. What are … Continue Reading

Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity

In the third installment of our series, Covington’s global cross-practice Digital Health team considers some additional key questions about Artificial Intelligence (AI), data privacy, and cybersecurity that companies across the life sciences and technology sectors should be asking to address the regulatory and commercial pieces of the complex digital health puzzle. AI, Data Privacy, and Cybersecurity 1. … Continue Reading

Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions

In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional 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 Commercial Questions When Contracting for Digital … Continue Reading

Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One)

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 Solutions 1. What are … Continue Reading

Update on Telemedicine Parity

We have followed (here and here) the adoption of the Interstate Medical Licensure Compact (“IMLC”) by various states and the subsequent formation of a commission under the IMLC.  We believe that the IMLC presents one promising avenue for the proliferation of telemedicine.  In this post, we explore another initiative designed to encourage the development of … Continue Reading

New Developments in the Implementation of the Interstate Medical Licensure Compact (IMLC)

In July of 2015 we noted that nine states had enacted laws to join the Interstate Medical Licensure Compact.  We described this cooperative program intended to allow physicians to obtain expedited licenses to practice in multiple states.  This would facilitate the delivery of telemedicine across state lines; physicians are generally prohibited from practicing, even remotely, … Continue Reading

JAMA Study Finds Low Rate of Digital Health Technology Use Among Seniors

A research letter published this month in the Journal of the American Medical Association reported that only a small fraction of seniors in the United States use digital health technology. The authors applied statistical analysis to data gleaned from a nationally representative sample of Medicare beneficiaries age 65 and older. In 2011, 16% of seniors … Continue Reading

New York’s Electronic Prescription Requirement

On March 27, 2016, New York became the first State to require electronic prescribing for both controlled and non-controlled substances and to provide for civil and criminal penalties for doctors failing to comply. Electronic prescribing means the patient no longer receives a paper prescription; rather, he or she chooses a pharmacy to which the electronic … Continue Reading

FDA Regulation of mHealth Updates

At the Food Drug and Law Institute’s annual conference on April 21, 2015, Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center for Devices and Radiological Health (CDRH), held a discussion of “FDA Regulation of Mobile Health/Medical Applications.”  As we discussed in a previous post (see here), there have already been several … Continue Reading

Important Developments in FDA Regulation of Software, Including Mobile Apps

This year is set to bring several important developments from Congress and FDA relating to FDA regulation (or deregulation) of software, including mobile apps. FDA has recently issued several draft and final guidances in this space and Congress has circulated several draft bills. Most recently, the House Energy and Commerce Committee released a discussion draft … Continue Reading

JP Morgan Conference Highlights eHealth Technologies, Data-Driven Therapeutics

The excitement around eHealth innovations was palpable throughout San Francisco this week as the annual JP Morgan healthcare conference flooded the city.  JP Morgan itself offered panels and presentations from industry leaders and emerging companies, while simultaneously occurring conferences, speaker programs, and networking events throughout San Francisco featured discussions on the changing face of healthcare … Continue Reading

FTC Remarks Signal Heightened Focus on Mobile Health Devices

Federal Trade Commission (FTC) chairwoman Edith Ramirez’s remarks at the International Consumer Electronics Show on Tuesday signal that FTC may be paying increased attention to privacy and security issues in the mobile health industry. The speech focused on how “the introduction of sensors and devices into currently intimate spaces – like our homes, cars, and … Continue Reading
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