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British Standards Institution (BSI)

BSI issues position paper on emergence of AI and machine learning algorithms in healthcare 11/02/2019

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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Addendum to safety of electronic control systems standard published 12/11/2015

As industry becomes increasingly automated, electrical control systems are playing a larger role in machine safety. Meanwhile those systems are using more complex electronics.

Against this background, BSI, the business standards company, has published BS EN 62061:2005+A2:2015 Safety of machinery - Functional safety of safety-related electrical, Electronic and programmable electronic control system. BS EN 62061 provides requirements for safety-related machine control systems, and explains the necessary level of risk reduction that can be achieved.

This international standard was developed as a derivative of IEC 61508*, which introduced the concept of functional safety and applies across all industry sectors. BS EN 62061 takes the provisions, rationale and SIL (safety integrity level) classification system of IEC 61508, and interprets them for machinery control systems.

Since safety related electrical control systems are intended to assist in the prevention of accidents and the protection of people from harm, any organization or individual who has a duty to ensure safety at machinery should be aware of BS EN 62061. This includes machinery designers, control system manufacturers and integrators, and others involved in the specification, design and validation of Safety-Related Electrical Control Systems of machinery. In particular it will be of interest where SIL classification is required. This is often a requirement where machinery is used in other sectors such as process or power generation.

What BS EN 62061 does:

  • Sets out an approach and provides requirements to achieve the necessary specification, design and performance
  • Offers assurance that a safety related control system has the required integrity required for the level of risk
  • Allows users to claim a presumption of conformity with the relevant health and safety requirements of Machinery Directive 2006/42/EC
  • Within the UK, helps compliance with the Supply of Machinery (Safety) Regulations and the Provision and Use of Work Equipment Regulations (PUWER)

Anne Hayes, head of Market Development for Governance & Risk at BSI said: "Automated systems rely upon sound electrical controls to keep them functioning, and the operators safe. As industrial demand grows, so does the importance of having a requirements document outlining appropriate measures to mitigate risks faced by machinery operators. Industry made it very clear what it wanted with this standard. Input came from experts nominated by their respective national standards bodies for their knowledge in the fields of design, usage, manufacture and statutory requirements for the safety of machinery control systems.”

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