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Services Regulation

HIQA Standards

HIQA has the power to set standards on safety and quality in relation to services provided by a service provider or a person carrying on the business of providing prescribed private health services,

It may set standards as the Authority considers appropriate for the Executive, the Agency, service providers or a person carrying on the business of providing prescribed private health services respecting data and information in their possession in relation to services and the health and welfare

The Authority may undertake an investigation as to the safety, quality and standards of any of the services described.

Key Definitions

A ‘health service’ means the provision of clinical care or any ancillary service to a person for—

  • the screening (other than screening carried out by a cancer screening service), preservation or improvement of the health of the person,
  • the prevention, diagnosis, treatment or care of an illness, injury or health condition of the person,
  • the performance or surgery, or a surgical intervention, in respect of aesthetic purposes, or other non-medical purposes, which involves instruments or equipment being inserted into the body of the person, or
  • a cancer screening service;

A ‘private hospital’ means a hospital under the management or control of a person (other than the Executive) at which—

  • medical or surgical treatment for illness, injury, disability, palliative, obstetric or gynaecological care, or
  • a health service,

is provided to a person which provision of treatment is under the direction of registered medical practitioners from at least 3 different medical specialities who are registered in the Specialist Division of the register of medical practitioners. It must also be  capable of accommodating one or more persons in that hospital when providing the treatment under paragraph (a), for a minimum period of 24 hours, but does not include—

  • a designated centre,
  • a centre registered by the Mental Health Commission,
  • a service provider to which paragraph (a) of the definition of service provider applies, or
  • a hospital which is in receipt of assistance from HSE under section 39 of the Act of 2004 (S.39 Body);

“‘service provider’ means—

  • a person who enters into an arrangement under section 38 of the Act of 2004 to provide a health or personal social service on behalf of the Executive,
  • a person who is in receipt of assistance under section 39 of the Act of 2004 in an amount that exceeds an amount prescribed for the purpose of this subparagraph,
  • a service provider under the Child and Family Agency Act 2013, or
  • a private hospital;

HIQA Investigation

HIQA may investigate where there may be a serious risk  to the health or welfare of a person receiving those services, or  of a failure to comply with the provisions of the Act of 2023, notwithstanding that such a risk may also exist elsewhere in those services,”,

It may consider a risk may be the result of any act, failure to act or negligence on the part of—

  • the Executive,
  • the Agency,
  • a service provider
  • the registered provider of a designated centre
  • a person carrying on the business of providing a prescribed private health service, “

An investigation may be in the interests of—

  • improving the safety, quality and standards of the services described which are the subject of the investigation, or
  • the provision of health and personal social services for the benefit of the health and welfare of the public.”,

The Authority shall notify the Minister in writing before undertaking an investigation.

Minister Require Investigation

The Minister may, if he or she believes on reasonable grounds that—

  • there may be a serious risk of the kind mentioned notwithstanding that such a risk may also exist elsewhere in those services,
  • the risk may be the result of any act, failure to act or negligence of the kind mentioned.
  • an investigation may be in the interests of improving the safety, quality and standards of the services described which are the subject of the investigation, or the provision of health and personal social services for the benefit of the health and welfare of the public,

require the Authority to undertake an investigation in accordance with this section.”,

The Minister for Children and Youth Affairs may, if he or she believes on reasonable grounds that—

  • there may be a serious risk of the kind mentioned notwithstanding that such a risk may also exist elsewhere in those services,
  • the risk may be the result of any act, failure to act or negligence mentioned and
  • an investigation may be in the interests of— improving the safety, quality and standards of the services described which are the subject of the investigation, or the provision of health and personal social services for the benefit of the health and welfare of the public,

require the Authority to undertake an investigation in accordance with this section.”,

Where such an investigation is being undertaken in respect of the services specified the Authority shall—

  • give notice in writing to the relevant person of the matters to which the investigation relates, and
  • give the relevant person a copy of any document which in the reasonable opinion of the Authority is relevant to the investigation.

Standards set by Authority.

The Authority shall, prior to submitting a draft standard to the Minister for approval, publish a notice on the website of the Authority stating that—

  • it proposes to set a standard,
  • a draft of the proposed standard is available on that website for the period specified in the notice, and
  • submissions in relation to the draft standard may be made in writing to the Authority on or before that date.

The Authority may consult with such other persons on the draft standard as the Authority thinks fit.

The Authority shall notify the Minister and the Minister for Children and Youth Affairs, where appropriate, before undertaking a consultation.

After considering any representations made to it on the draft standard and making any changes to the draft standard that the Authority thinks fit in view of those representations or otherwise, the Authority shall submit the draft standard to the Minister for approval and, where the standard relates to services provided under the Child and Family Agency Act 2013 , the Minister shall not approve the draft standard without the prior consent of the Minister for Children and Youth Affairs.

Where the Minister approves a standard under this section, he or she shall cause a notice of the approval to be published in Iris Oifigiúil and the notice shall specify the date from which the standard shall come into operation.

The Authority may revoke or amend a standard approved.

A standard set by the Authority before the coming into operation of the 2023 Act and which is in force immediately before that commencement shall continue in force after such amendment unless revoked or amended by the Authority.

Provision of information to Authority

The Authority may require—

  • the Executive,
  • the Agency,
  • a service provider, or
  • a person carrying on the business of providing a prescribed private health service,

to provide it with any information or statistics that the Authority needs in order to determine the level of compliance by the Executive, Agency, service provider or the person carrying on the business of providing a prescribed private health service, as the case may be, with the standards set by the Authority.

The following  applies where it appears to the chief inspector that a specified incident has occurred, following—

  • the receipt by the chief inspector of a complaint in relation to the specified incident concerned,
  • the notification of the specified incident concerned to the chief inspector by a relevant entity, or
  • the chief inspector otherwise becoming aware of the specified incident concerned.

Review of Incident

The chief inspector may undertake a review of the specified incident where he or she considers it appropriate to do so, having regard to all of the circumstances, in order to—

  • identify, in so far as possible, how the specified incident concerned occurred, and
  • make any recommendations of a general character arising out of any findings that can be implemented to reduce risk and to improve the safety, quality and standards of services provided by the relevant entity or relevant entities, as the case may be, where the specified incident occurred.

The chief inspector may decide not to undertake a review, or decide to discontinue such a review, if—

  • the chief inspector believes on reasonable grounds that the complaint is frivolous or vexatious,
  • the specified incident, the subject of the review concerned, has already been subject to a review under this section,
  • the chief inspector believes on reasonable grounds that the incident the subject of the review concerned is not a specified incident,
  • the chief inspector believes on reasonable grounds that, the subject matter of the review concerned has already been resolved or substantially resolved,
  • the subject matter of the review concerned is the subject of criminal proceedings, or
  • the review concerned is the subject of an investigation by An Garda Síochána.

The chief inspector shall not undertake a review of a specified incident after the expiration of one year from the later of the following dates:

  • the date on which the specified incident occurred;
  • the date on which the complainant knew or could reasonably be expected to know that the specified incident occurred, or
  • after the expiration of one year from the date on which the specified incident occurred.

Prescribed private health services.

The Minister, having consulted the Authority and any other person as he or she considers appropriate, may prescribe a health service to be a prescribed private health service for the purposes of this Act. The Minister shall have regard to the following matters:

  • whether the service is provided on an in-patient, day-patient or out‑patient basis;
  • whether the service is provided in a hospital (other than a private hospital) where medical or surgical treatment for illness or injury, disability, palliative, obstetric or gynaecological care is provided;
  • whether a general anaesthetic is administered to a patient in the provision of that service;
  • whether the service is provided in a hospital (other than a private hospital) where the provision of the service is under the direction of registered medical practitioners from at least 3 different medical specialities who are registered in the Specialist Division of the register of medical practitioners;
  • whether the service that is being provided is arranged by the National Treatment Purchase Fund Board under the National Treatment Purchase Fund Board (Establishment) Order 2004 ( S.I. No. 179 of 2004 );
  • whether the service that is being provided includes the performance of surgery, or a surgical intervention, in respect of aesthetic purposes, or other non-clinical purposes, that involves instruments or equipment being inserted into the body of the patient.

When prescribing a health service to be a prescribed private health service under subsection (1), the Minister shall not prescribe health services provided—

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