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.
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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), 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.
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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
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 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:
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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,
Three EHR Issues to Watch in 2018
As 2018 gets underway, EHR vendors and users continue to face challenges and uncertainty. There are three legal and regulatory issues in particular that we think are important to watch over the next 10 months:
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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
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 agency’s initial interpretation of the health software provisions enacted as part of last year’s 21st Century Cures Act (the “Cures Act”).
Given the rapid pace of digital health innovation across the life sciences, technology and health care sectors, FDA guidance on these topics is critical. Here are a few key takeaways from the draft guidances:
- FDA’s initial interpretation of the Cures Act provision related to clinical decision support (CDS) software may lead to a fairly narrow carve-out—in other words, many cutting-edge CDS software functions could remain subject to FDA regulation.
- FDA’s draft guidances do not directly address dynamic digital health solutions, such as those that incorporate machine learning, artificial intelligence (AI), or blockchain.
- FDA has proposed an enforcement discretion approach for decision support software aimed at patients that generally parallels the regulatory approach for CDS software aimed at clinicians, even though patient decision software was not addressed directly in the Cures Act.
- Consistent with the Cures Act, FDA’s draft guidances reflect that many of the software functions that were previously subject to FDA enforcement discretion (i.e., not actively regulated as devices) no longer meet the definition of “device.”
- Significant for pharmaceutical companies, CDER joined one of the draft guidances, and that draft guidance makes clear that other FDA requirements may apply to digital health products disseminated by or on behalf of a drug sponsor beyond those outlined in the draft guidance.
FDA’s regulatory approach has a significant impact on the investment in and development of digital health solutions across the digital health ecosystem. Stakeholders should consider submitting comments to the agency to help shape the direction of FDA’s final guidances on these topics.
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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 the key questions when crafting warnings and disclosures?
If your product is regulated, your warnings and disclosures will need to comply with any relevant regulations. In the case of a product not regulated by the FDA or equivalent regulatory body, first consider how your warnings and disclosures will be incorporated into the use of the product.
Some disclosures, like an explanation of the data source used by software, may fit best in terms and conditions that a user sees before using the product. Key warnings, however, may be more appropriately placed as part of the user experience.
Example: A warning that patients should consult their doctors if necessary may need to be placed in proximity to specific medical content.
Best Practice: Consider your intended audience: are you writing warnings for doctors, patients, or institutions? The appropriate types of disclosures will vary across populations. Patient-directed warnings may also need to be written in simplified language.
Best Practice: Consider whether it is appropriate for your product to have users to accept or otherwise be required to agree to the warnings and disclosures.
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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