Internet of Things (IoT)

As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities.  From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in…
Continue Reading 5 Digital Health Issues to Watch at FDA in 2022

On June 22, 2021, Congressional leaders Diana DeGette (D-DO) and Fred Upton (R-MI) released a bipartisan follow-up to the 2016 21st Century Cures Act.  “Cures 2.0”—a “discussion draft” at this stage—is intended to build upon the Cures Act.  The draft lays out several notable policies related to digital…
Continue Reading Reps. DeGette and Upton Release Highly-Anticipated “Cures 2.0” Draft

FDA has long recognized the significant potential of artificial intelligence- and machine learning- (AI/ML-) based software as a medical device (SaMD) to transform health care as well as the unique challenges presented by AI/ML-based software under the Agency’s traditional medical device regulatory framework.  On January 12, 2021, FDA issued the…
Continue Reading FDA Releases AI Action Plan

In this edition of our regular roundup on legislative initiatives related to artificial intelligence (AI), cybersecurity, the Internet of Things (IoT), and connected and autonomous vehicles (CAVs), we focus on key developments in the European Union (EU).
Continue Reading AI, IoT, and CAV Legislative Update: EU Spotlight (Third Quarter 2020)

In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad concepts and apply generally — but, in places, they specifically mention healthcare and medical devices.

The Commission recognizes the important role that AI and big data analysis can play in improving healthcare, but also notes the specific risks that could arise given the effects that such new technologies may have on individuals’ health, safety, and fundamental rights. The Commission also notes that existing EU legislation already affords a high level of protection for individuals, including through medical devices laws and data protection laws. The Commission’s proposals therefore focus on addressing the gap between these existing rules and the residual risks that remain in respect of new technologies. Note that the Commission’s proposals in the White Paper on AI are open for public consultation until 19 May 2020.Continue Reading European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)

On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI.  These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days.  Although the papers published this week do not set out a comprehensive EU legal framework for AI, they do give a clear indication of the Commission’s key priorities and anticipated next steps.

The Commission strategies are set out in four separate papers—two on AI, and one each on Europe’s digital future and the data economy.  Read together, it is clear that the Commission seeks to position the EU as a digital leader, both in terms of trustworthy AI and the wider data economy.Continue Reading European Commission Presents Strategies for Data and AI (Part 1 of 4)

On 19 September 2019, the European Parliamentary Research Service (“EPRS”)—the European Parliament’s in-house research service—released a briefing paper that summarizes the current status of the EU’s approach to developing a regulatory framework for ethical AI.  Although not a policymaking body, the EPRS can provide useful insights into the direction of EU policy on an issue.  The paper summarises recent calls in the EU for adopting legally binding instruments to regulate AI, in particular to set common rules on AI transparency, set common requirements for fundamental rights impact assessments, and provide an adequate legal framework for facial recognition technology.

The briefing paper follows publication of the European Commission’s high-level expert group’s Ethics Guidelines for Trustworthy Artificial Intelligence (the “Guidelines”), and the announcement by incoming Commission President Ursula von der Leyen that she will put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within her first 100 days in office.Continue Reading European Parliamentary Research Service issues a briefing paper on implementing EU’s ethical guidelines on AI

On 29 March 2019, the ICO opened the beta phase of the “regulatory sandbox” scheme (the “Sandbox”), which is a new service designed to support organizations that are developing innovative and beneficial projects that use personal data.  The application process for participating in the Sandbox is now open, and applications…
Continue Reading ICO opens beta phase of privacy “regulatory sandbox”

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?

Designing data-driven products and services in compliance with privacy requirements can be a challenging process.  Technological innovation enables novel uses of personal data, and companies designing new data-driven products must navigate new, untested, and sometimes unclear requirements of privacy laws, including the General Data Protection Regulation (GDPR).  These challenges are often particularly acute for companies providing products and services leveraging artificial intelligence technologies, or operating with sensitive personal data, such as digital health products and services.

Recognising some of the above challenges, the Information Commissioner’s Office (ICO) has commenced a consultation on establishing a “regulatory sandbox”.  The first stage is a survey to gather market views on how such a regulatory sandbox may work (Survey).  Interested organisations have until 12 October to reply.

The key feature of the regulatory sandbox is to allow companies to test ideas, services and business models without risk of enforcement and in a manner that facilitates greater engagement between industry and the ICO as new products and services are being developed.

The regulatory sandbox model has been deployed in other areas, particularly in the financial services sector (see here), including by the Financial Conduct Authority in the UK (see here).

Potential benefits of the regulatory sandbox include reducing regulatory uncertainty, enabling more products to be brought to market, and reducing the time of doing so, while ensuring appropriate protections are in place (see the FCA’s report on its regulatory sandbox here for the impact it has had on the financial services sector, including lessons learned).

The ICO indicated earlier this year that it intends to launch the regulatory sandbox in 2019 and will focus on AI applications (see here).

Further details on the scope of the Survey are summarised below.Continue Reading ICO consults on privacy “regulatory sandbox”