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In AI Act

AI Developers to Access Hungarian Health Data by 2026

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From 2026, Hungarian legislation will allow access to health-related data stored in its National eHealth Infrastructure (EESZT) for AI development on a case-by-case basis. With this change, Hungary could capitalise on its investments into launching the EESZT platform in 2017 and standardising the health data collected by healthcare providers using the platform in the past years. In this article, we highlight the key differences compared to the EU’s European Health Data Space (EHDS) proposal and…

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In Digital Health

EHDS Deep-Dive: EHR systems, wellness apps and medical devices (Part 4)

by , and 6 Mins Read

After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? This is the fourth post in our EHDS series. In this post, we focus on the new product regime for electronic health record (EHR) systems, including the impact on wellness apps, AI systems and medical devices. We examine the latest publicly available draft, dated 24…

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In Digital Health

EHDS Deep-Dive: New pathway for accessing health data (Part 3)

by , and 11 Mins Read

After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? This is the third post in our EHDS series. In this post, we focus on the change that has been generating all the headlines: a new pathway to access health data for secondary uses like research and innovation. We examine the impact of this pathway…

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In Digital Health

EHDS Deep-Dive: New pathway for accessing health data (Part 2)

by , and 10 Mins Read

After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? In this post, we focus on the change that has been generating all the headlines: a new pathway to access health data for secondary uses like research and innovation. So what can you expect? This is the second post in our EHDS series, and we…

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In Digital Health

European Health Data Space Deep-Dive: Health data rights (Part 1)

by , and 6 Mins Read

After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for you? This is the first post in our series on the EHDS. This post focuses on new health data rights, and we examine the latest publicly available draft, dated 24 April 2024. So what’s the impact on the pharmaceutical and medtech industry? In one way, it’s limited…

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In Digital Health

Machine Learning Medical Devices – FDA, UK MHRA and Health Canada Join Forces (Again) in Promoting Transparency

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In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) collaboratively identified ten guiding principles for good machine learning practice (GMLP). These principles aim to ensure the safe, effective, and high-quality development of AI/ML technologies in medical devices. Building on GMLP, these agencies are now developing a proposed regulatory framework for modifications to Artificial Intelligence / Machine Learning (AI/ML) – Based Software as a…

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In Digital Health

MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 30 April 2024 set out its strategic approach to artificial intelligence (AI). In particular, the MHRA welcomed the publication of the UK Government’s white paper ‘A pro-innovation approach to AI regulation’, published in 2023, and has taken significant steps in the past 12 months to adopt its recommendations in the work they do based on five key strategic principles. These principles encompass safety, security and robustness; appropriate…

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In Digital Health

The EU AI Act and medicines R&D: EFPIA brings clarity, but open questions for devices

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How does the EU AI Act impact upon medicines R&D? The answer is not much at all. This position stems from an exemption for scientific R&D in the AI Act, as explained by a recent statement from the European Federation of Pharmaceutical Industries and Associations (EFPIA). This will be welcome news for the pharmaceutical industry, but questions remain for the medical device industry, where the position is far murkier at the research and development stages.…

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In Digital Health

Clinical Trials Agreements – How Much Flexibility is there for Sponsors Across the Globe?

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Baker McKenzie has recently conducted a survey across over 100 jurisdictions, asking our Healthcare & Life Sciences global network of specialists to compare the degree of flexibility clinical trial sponsors have to negotiate with sites in clinical trial agreements. We have received input from our healthcare regulatory experts in 105 jurisdictions and are therefore able to build a global picture of how the flexibility afforded to sponsors varies from market to market. The results are…

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In Digital Health

EU AI Act Approved by the EP – Update and Insight Into Other AI Industry Specific Developments

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EU AI Act On 13 March, the European Parliament approved the EU AI Act. The link to the adopted text is available here. The next step is Council’s adoption, expected next month. Following the Council’s sign off, the final text will be prepared for publication in the Official Journal and will enter into force 20 days afterwards. Once adopted, the Act will become applicable in a gradual manner. For products that are already required to…

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