ISO: Technical Report Ensures Patient Safety via Health Software - ISO TR 27809
September 5, 2007 // Published as a news service by IHS
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The International Organization for Standardization (ISO) released a technical report, ISO TR 27809:2007 - Health informatics - Measures for ensuring patient safety of health software, which considers the control measures required to ensure patient safety in respect to health software products and the standards needed to underpin them.
Experts said the technical report is aimed at reducing the number of patients harmed, or even killed, due to the misuse or malfunction of software for health care.
Its scope is intended to cover those health software products which are not, in practice, covered by medical device regulations.
In the past, health-related software was primarily applied to relatively non-critical administrative functions and clinical decision support systems tended to be relatively simple and understandable in their logic when used as a background adjunct to decisions, rather than a major influence on which to routinely rely. As a result, the potential for harm to the patient, as distinct from disruption to the organization, was low.
Experts said this has substantially changed and the nature of these changes will increase the potential for risks to patients. Incidents where health software has caused harm to, or the premature death of, patients has severely affected the trust of the general public. These incidents have also had consequences on the reputation of health organizations and led to substantial legal damages.
According to the ISO, those responsible for health care organizations need to recognize that:
- Health software products have the potential to harm patients.
- This potential is growing as the complexity of implementations grows.
- Health care organizations are increasingly reliant on health software products.
- Standards for manufacture and use need to be created and adhered to if harm is to be avoided.
ISO said manufacturers need to recognize that:
- Controls need to be exerted over the conception, design, production and deployment of health software, and standards are required for all of these aspects, including quality control and risk management.
- In the future, such controls are likely to be demanded by customers and regulators.
ISO TR 27809:2007 considers the standards which will be necessary if health software safety is to be ensured through controls exerted throughout a product's life cycle. As its starting point, it considers the standards and controls applied to medical devices and offers practical solutions for adapting them to health software products.
Source: International Organization for Standardization (ISO).