Medical Device Regulation Archives

Of Digital Interest Quarterly Roundup | Q1 2023

by McDermott Will & Emery | May 3, 2023 | Telehealth

McDermott’s digital health team continually monitors legal developments affecting all aspects of the remote delivery of care. This inaugural issue of our Of Digital Interest Quarterly Roundup highlights key issues and trends in the first quarter of 2023.

Remote care is an important development in care delivery, but the regulatory patchwork is complicated. Our digital health team works alongside the industry’s leading providers, payors and technology innovators to help them enter new markets, break down barriers to delivering accessible care and mitigate enforcement risk through proactive compliance. Are you working to make healthcare more accessible through telehealth?

Download the report here.

FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

by Anisa Mohanty and Vernessa T. Pollard | Jul 24, 2019 | General Interest

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program.

There are two criteria for inclusion in the Breakthrough Device Program:

The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and
The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients.

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Digital Health in the UK: The New Regulatory Environment Under the Medical Device Regulation

by Gary Howes and Sharon Lamb | Jul 3, 2019 | Data Privacy

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long Term Plan, which set out ambitious aims for the acceleration and adoption of digital health and AI, particularly in primary care, outpatients and wearable devices.

Although these developments are encouraging to developers, there is still no clear framework for reimbursement or tariffs for digital health tools and AI.

At the same time, the plethora of new technologies has led to increased calls for regulation and oversight, particularly around data quality and evaluation. Many of these concerns may be addressed by the new Medical Device Regulation (MDR) and other regulatory developments. In fact, there is some risk that while regulatory landscape is moving quickly, the pricing environment is still a way behind.

In May 2020, the new MDR will change the law and process of certification for medical software. The new law includes significant changes for digital health technologies which are medical devices. In March 2019, the National Institute for Health and Care Excellence (NICE) also published a new evidence standards framework for digital health technologies. The Care Quality Commission (CQC) already regulates online provision of health care, and there are calls for wider and greater regulation. The government has also published a code on the use of data in AI.

Digital Health Technologies and the MDR

The new MDR will mean a significant change to the regulatory framework for medical devices in the European Union.

As with the previous law, the MDR regulates devices through a classification system.

The new regime introduces new rules for medical software that falls within the definition of device. This will mean significant changes for companies that develop or offer medical software solutions, especially if their current certification has been “up-classed” under the MDR.

Key Takeaways for Investors in Digital Health Tools

Companies and investors in digital health should:
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Of Digital Interest Quarterly Roundup | Q1 2023

FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

Digital Health in the UK: The New Regulatory Environment Under the Medical Device Regulation

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