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Home >BSI issues position paper on emergence of AI and machine learning algorithms in healthcare
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BSI issues position paper on emergence of AI and machine learning algorithms in healthcare

11 February 2019

BSI, the business standards company, has undertaken research in collaboration with the US standards organization for medical devices, the Association for the Advancement of Medical Instrumentation (AAMI), to analyse the role that standardization can play in assisting the deployment of AI solutions in healthcare. This research has been undertaken with support from UK medical device regulator, MHRA.

Both the UK and US are acknowledged leaders in innovation for medical technologies and digital healthcare, with regulatory regimes that are considered to be amongst the most rigorous and responsive to innovation worldwide. Both MHRA and US FDA have a shared interest in the recommendations in this report.

Novel medical software can offer earlier diagnosis and targeted treatments for patients whilst ensuring efficiency in healthcare services. However, the emergence of AI and machine learning algorithms in what is already a highly regulated sector, is posing a challenge to future governance and regulation, in terms of safety and effectiveness.

The research, therefore, explored specific challenges relating to the deployment of AI in healthcare, including the ability of an algorithm to change its output in response to new data, and the level of autonomy introduced by the use of such software.

Anne Hayes, head of Governance and Resilience at BSI, said: "The healthcare sector is embracing AI with the expectation it can revolutionize patient care in the future, yet this must be balanced with the need to ensure consistency of safety, effectiveness, scalability and fitness for purpose. The recommendations offered in this position paper will ensure that we have a robust standardization framework to support the effective deployment of these innovative solutions."

Mark Birse, group manager, Device Safety and Surveillance at the Medicines and Healthcare Products Regulatory Agency, said: “We live in an increasingly digital world, both healthcare professionals, patients and the public are using software and stand-alone apps to aid diagnosis and monitor health. Making sure these new software devices including those using artificial intelligence, are safe and effective is a challenge for developers as well as users.

“Making sure the introduction and deployment of these tools into everyday healthcare is done safely is a priority for us as regulators. Standards will be a critical element of this.

“We were pleased to be able to initiate this important work and will continue to support both the emerging challenges, and the solutions.”

The paper recommends a phased programme of standardization activities, including development of guidelines to cover AI terminologies and validation approaches.

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