On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug manufacturing to seek public input on issues of critical focus (the “AI Discussion Paper”). While both actions are significant, the AI Discussion Paper is one of CDER’s few policy statements related to the deployment of AI around regulated activities (though the Center did establish an AI steering committee in 2020). CDRH, on the other hand, has issued several policy documents around AI-based software potentially regulated as “software as a medical device” (SaMD), including through an April 2019 discussion paper that proposed a regulatory framework for modifications to AI-based SaMD, an AI “Action Plan” for SaMD in January 2021, and guiding principles to inform the development of Good Machine Learning Practice for AI-based medical devices in October 2021. CDER has requested public comment on the recent DHT Discussion Paper and AI Framework by May 1 and 23, respectively.Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development
AI Update: European Commission Conducts Open Consultation on the European Health Data Space Initiative
On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”). The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.
Continue Reading AI Update: European Commission Conducts Open Consultation on the European Health Data Space Initiative
AI Update: NHSX Publishes “Buyer’s Checklist” for AI Solutions
NHSX recently published “A Buyer’s Checklist for AI in Health and Care” (Guidance) that sets out 10 key questions which will be of use to parties deploying AI solutions or conducting data driven projects (in a health and care setting or otherwise). For example, the Guidance highlights:
- key data-related considerations, such
AI Update: European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)
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 AI Update: European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)
IoT Update: The UK publishes a final version of its Code of Practice for Consumer IoT Security
Following an informal consultation earlier this year – as covered by our previous IoT Update here – the UK’s Department for Digital, Culture, Media and Sport (“DCMS”) published the final version of its Code of Practice for Consumer IoT Security (“Code”) on Oct. 14, 2018. This was developed by the DCMS in conjunction with the National Cyber Security Centre, and follows engagement with industry, consumer associations, and academia. The aim of the Code is to provide guidelines on how to achieve a “secure by design” approach, to all organizations involved in developing, manufacturing, and retailing consumer Internet of Things ‘IoT’ products. Each of the thirteen guidelines are marked as primarily applying to one or more of device manufacturers, IoT service providers, mobile application developers and/or retailers categories.
The Code brings together what is widely considered good practice in IoT security. At the moment, participation in the Code is voluntary, but it has the aim of initiating and facilitating security change through the entire supply chain and compliance with applicable data protection laws. The Code is supported by a supplementary mapping document, and an open data JSON file which refers to the other main industry standards, recommendations and guidance. Ultimately, the Government’s ambition is for appropriate aspects of the Code to become legally enforceable and has commenced a mapping exercise to identify the impact of regulatory intervention and necessary changes.Continue Reading IoT Update: The UK publishes a final version of its Code of Practice for Consumer IoT Security