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The Health Information and Patient Safety Bill (“Bill”) aims to address the issue of patient safety through various tools, as set out below. The Minister for Health emphasised that the aim of the Bill is to promote and create a culture of patient safety in the wake of several recent high profile and tragic incidents which have served to undermine public confidence in the Irish health system.
To achieve the objectives, a range of measures are proposed, which include:
- The mandatory reporting of adverse events resulting in death or serious harm. The Bill provides for the voluntary reporting of less serious events and ‘near misses’.
- The establishment of a new patient safety watchdog, to ensure that the health service identifies, responds to and learns from errors in an effective and efficient manner.
- The establishment of a new Patient Safety Office, which will be responsible for collecting and analysing information and intelligence.
- The sharing of information between health regulators in circumstances where the informing body has a reasonably held belief that the information in question is appropriate and necessary to share with other regulatory bodies.
- The Bill provides a regulatory framework for ‘data matching’, which is described as personal information gathered for one purpose by a health organisation that is later ‘matched’ with personal information gathered for a different purpose by the same organisation. The rationale is that the collection of these separate strands of information will serve to provide health professionals with a better and more complete understanding of an individual within the health system.
- The extension of HIQA’s powers, to ensure consistent compliance with standards across the sector. This will be achieved by extending HIQA’s authority in terms of setting standards, monitoring compliance with standards and carrying out investigations. Furthermore the Bill allows for the extension of HIQA’s remit to include private health operators including private hospitals and cosmetic surgery clinics in respect of high risk procedures.
There may be concerns raised over whether the draft legislation gives rise to a data protection law issue, as it seeks to make changes to data protection law which would allow sensitive personal data to be disclosed to health researchers without the consent of the individuals concerned. Under this proposal the Data Protection Commissioner would have a role in determining which research projects would be permitted access to such data.
The researcher seeking the data would be required to show that they require access to the personal data, as opposed to anonymised data, and also that the data would not be used in a way which would cause ‘damage or distress’ to the individual concerned. It is envisaged that access to such data would be granted in strict and limited circumstances.
It is possible that such a scenario may potentially give rise to a balancing of rights issue. A question may be raised in respect of whether the public interest in such information outweighs the right to privacy of the individual whose personal health information has been disclosed. However, the Bill purports to be cognisant of and consistent with the new EU General Data Protection Regulation which is due to be finalised shortly.
We will provide updates as the Bill progresses.
The revised general scheme of the Health Information and Patient Safety Bill can be viewed here.