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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Medicare Advantage Organizations Provided New Opportunities to Offer Telehealth Benefits

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), … 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

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

FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations

On Friday, on the InsideMedicalDevices blog, our colleagues posted a summary and analysis of the FDA’s draft guidance encouraging clinical investigators to make their electronic data capture systems interoperable with health care organizations’ electronic health records.  To read the post, please click here.… Continue Reading

CMS Issues Guidance Encouraging the Use of Commercial Off-the-Shelf Technology and Software-as-a-Service for Medicaid Eligibility and Enrollment Systems

In March, CMS issued a State Medicaid Directors Letter (SMDL) about the availability of enhanced federal funding for state Medicaid programs’ eligibility and enrollment (E&E) systems. This SMDL represents CMS’s most recent effort to encourage States to use commercial “off-the-shelf” technology and “software as a service,” instead of customized electronic systems developed and built specifically … Continue Reading

Health Care Companies Agree to “Core Commitments” to Improve Access to EHR

Last month, the Department of Health and Human Services (HHS) announced that a number of large health care companies and providers had “agreed to implement three core commitments” to improve access to electronic health records (EHR).  HHS touted the commitments as a significant step toward increased EHR interoperability.… 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

After Two-Day Workshop, CDRH Releases Postmarket Cybersecurity Draft Guidance

Earlier today, on the InsideMedicalDevices blog, our colleague Christopher Hanson posted a summary of the FDA’s recent issuance of draft guidance on “Postmarket Management of Cybersecurity in Medical Devices.”  The release of the draft guidance coincided with the conclusion of a two-day public workshop hosted by the FDA entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.”  You … Continue Reading

New CMS Rule Permits Home Health Face-to-Face Encounters to Occur Through Telehealth Technology

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) finalized a rule implementing a provision of the Affordable Care Act (ACA) that requires a Medicaid enrollee seeking coverage for home health services to first meet face-to-face with a practitioner.  The final rule confirms that the face-to-face encounter requirement “may occur through telehealth, as implemented … Continue Reading
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