"First do no harm" - Clinical Safety Management in e-health

Whilst rare, it is an unfortunate fact of life that the very health services that the public rely on to make them better can end up causing them harm.

Errors in medication management, incorrect or 'wrong-side' surgery and hospital acquired infection can all contribute to patient mortality and morbidity. No wonder then that patient safety management is becoming such a high priority for the boards of healthcare organisations. However, to date much of this has been focussed on traditional "Quality and Safety" areas such as falls, wound infections, medication misadventure, etc and does not include an Information Technology (IT) clinical safety management function.

IT is often introduced as a frequent and powerful component of providers' strategies to reduce clinical risks, but this presents a paradox. IT also has the potential to introduce new hazards for patients: electronic drug charts, for example, may not be available on an organisation-wide basis, or electronic health records may fail to correctly display critical clinical information for individual patients[1].

With the progressive integration of IT within healthcare there is further potential to introduce new causes for harm to patients through the increased use of networks, mixing of medical and non-medical applications, as well as some poor software design and the threat of virus[2] and malicious attacks. Some standards bodies are calling for greater controls. For example the British Standards Institute[3] has recommended that manufacturers and departments need to stop on-site informal design and adaptation of medical software and regulators need to shift their focus on standardisation to enable safer integration services.

Events and the anxieties of standards bodies have sparked urgent debate in the international health informatics community about how best to control the risks of harm associated with introducing new technology. Those responsible for procuring and implementing healthcare IT are also considering their options for managing the associated clinical risks.

It is globally recognised that there are no international standards specifically addressing the management of patient safety associated with the development and deployment of health software. Attempts to address this materialised in the form of the introduction of the following two draft ISO standards accepted for joint work under the Vienna agreement between ISO/TC215 and CEN/TC251. BT through its work with and requirements of the NHS, in combination with experience in digital hospitals and shared electronic records in the UK and elsewhere, was a significant participant and contributor in the development of these two draft standards:

  • ISO/DTS 29321 – Health Informatics: Application of risk management to the manufacture of health software.
  • ISO/DTR 29322 – Health Informatics: Guidance on risk evaluation and management in the deployment and use of health software.

These two draft standards were later withdrawn by the joint working group but have since been adopted by the NHS Information Standards Board as DSCN 14:2009 and DSCN 18:2009.

On a more unified international front things are still progressing rapidly. In October 2010 a new international standard, ISO / IEC 80001-1: Application of risk management for IT-networks incorporating medical devices was approved. This standard is aimed at healthcare organisations, ensuring that they assess the risks associated with integrating a medical device into a health IT network, and relies upon medical device manufacturers and IT suppliers having already conducted safety work prior to bringing their product to market. In addition some countries have addressed the issue in different ways in some cases by extending the scope of medical device regulations. In ensuring BT is globally compliant, BT Health has in place a clinical management system, Sentry, which has primarily adopted from:

  • IEC 61508 – Functional safety of electrical, electronic, programmable electronic safety related systems
  • ISO 14971:2007 – Medical Devices – Application of risk management to medical devices
  • ISO/TS 23258 - Classification of Risks from Health Informatics products
  • ISO/TR 27809:2007 – Health Informatics – Measures for ensuring patient safety of health software

All of the standards call for a systematic process to be in place that looks at:

  • Identifying clinical hazards in the design phase
  • Identifying what controls are currently in place
  • Designing in new controls
  • Testing that the controls work
  • Manage issues arising
  • Present findings/evidence to the Customer
  • Residual Risk as low as reasonably practicable
  • Review Service Incidents and update the Hazard Register with the relevant information

Sentry is a robust clinical safety management system built on safety management principles adopted from other industries in which managing risk is critical (for example aviation and nuclear engineering) and adapted to the healthcare IT environment by clinicians and safety engineers. In working with ISO on the standard, BT has ensured it is fully cognisant of the intended global implementation of ISO/IEC 80001.

A strong clinical safety management system must contain a set of policies and procedures that aligns with the IT product development lifecycle, with risk management activities conducted and documented at key stages in the product development, deployment and in-life phases. This wraparound assurance ensures that adherence to the safety process and verification of safety requirements is evidenced throughout the complete lifecycle of a product/service. The integrated approach culminates in the development of a formal clinical safety case for each release of a healthcare IT product.

However, to be effective a clinical safety management system cannot stand alone. Sentry is dependent upon a project being managed using appropriate project management and software development methodologies, together with a quality assurance framework such as ISO 9001:2000. Additionally, the assumption is that other work streams will conform to the appropriate standards in their area, e.g. Service Management with ISO/IEC 20000 and Information Security with ISO/IEC 27000.

Whilst much of the standards work in e-health is taking place in the northern hemisphere and globally the standards journey is still in its infancy, the southern hemisphere cannot ignore the implications. It is not just software vendors and systems integrators that will be required to adopt and inform the evolving standards. The organisational impact within healthcare organisations has yet to be fully realised, but will be both necessary and significant to ensure that their own e-health programmes also "first do no harm"[4].

Janette Bennett
Clinical Director - Asia Pac
BT Global Services

Martin Ellis
Patient Safety Director
BT Health

Competing Interests

Janette Bennett is the Clinical Director, Asia Pac, BT Global Services. Martin Ellis is the Patient Safety Director, BT Health.


  1. http://nextgov.com/nextgov/ng_20100304_9977.php
  2. http://www.telegraph.co.uk/technology/news/3482877/computer-virus-causes-havoc-at-London-hospitals.html
  3. Sensible Standards, IET, Michael Faraday House, 6 Hills Way, Stevenage, Herts, UK
  4. http://ancienthistory.about.com/od/greekmedicine/f/HippocraticOath.htm

Posted in Australian eHealth

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