Intended for healthcare professionals

Information In Practice

Verifying quality and safety in health informatics services

BMJ 2001; 323 doi: https://doi.org/10.1136/bmj.323.7312.552 (Published 08 September 2001) Cite this as: BMJ 2001;323:552
  1. Michael Rigby, senior lecturer (m.j.rigby@keele.ac.uk)a,
  2. Jari Forsström, directorb,
  3. Ruth Roberts, lecturerc,
  4. Jeremy Wyatt, directord

    for the TEAC-Health Partners.

  1. a Centre for Health Planning and Management, Keele University, Keele ST5 5BG
  2. b Medical Informatics Research Centre in Turku, University of Turku, FIN-20520 Turku, Finland
  3. c School of Postgraduate Studies in Medical and Health Care, University of Wales Swansea, Swansea SA2 8PP
  4. d Knowledge Management Unit, School of Public Policy, University College London, London WC1H 9QU
  1. Correspondence to: M Rigby

    Information and its handling and transmission form an essential part of health care and are reflected in professional standards. Automated information systems in health care—health informatics services—will improve these functions and bring new opportunities through the harnessing of modern information and communications technologies. Thus, computer support is now essential in many parts of medicine, the US Institute of Medicine has long espoused the value of computerised patient records,1 and many countries have developed strategies on this topic, and there are countless health related internet sites.

    However, as new information and communication technologies in health bring new opportunities, they also bring new risks. Emphasis has rightly been placed on ensuring appropriate levels of confidentiality in electronic information systems—to the point that the highly exacting requirements being demanded by independent commentators and professional bodies2 are difficult to satisfy without jeopardising the functioning of core services 3 4 or the interests of the most vulnerable groups.5 In contrast, much less thought has been given so far to ensuring the appropriateness of the design and integrity of functioning of health informatics services.

    Summary points

    Like drugs 40 years ago, products in health informatics are unregulated with regard to safety and efficacy

    A European project has now recommended ways of accrediting healthcare related software, telemedicine, and internet sites

    A scheme like CE marking of electrical goods is recommended for software, national regulatory bodies should be identified for telemedicine, and a European certification of integrity scheme developed for websites

    Importance of quality assurance of health informatics systems

    If informatics systems are increasingly essential in the delivery of health care then their integrity and quality must be of equal importance, but this has been scarcely recognised to date. In 1963 the then UK secretary of state for health stated to the House of Commons: “The House and the public suddenly …

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