Patient Information Advisory Group

Patient Information Advisory Group

The Patient Information Advisory Group (PIAG) was established in the United Kingdom under section 61 [ [http://www.opsi.gov.uk/acts/acts2001/10015--g.htm#61 section 61 of the Health and Social Care Act 2001] ] of the Health and Social Care Act 2001 [ [http://www.opsi.gov.uk/acts/acts2001/20010015.htm Health and Social Care Act 2001] ] and the Patient Information Advisory Group (Establishment) Regulations 2001 [ [http://www.opsi.gov.uk/si/si2001/20012836.htm Statutory Instrument 2001 No. 2836: Patient Information Advisory Group (Establishment) Regulations 2001] ] to provide advice on issues of national significance involving the use of patient information and to oversee arrangements created under section 60 [ [http://www.opsi.gov.uk/acts/acts2001/10015--g.htm#60 Section 60 of the Health and Social Care Act 2001] ] of the Act. Its membership is drawn from patient groups, health care professionals and regulatory bodies. Meetings of the PIAG take place four times a year, in March, June, September and December.

Terms of reference

The terms of reference for the PIAG are to:

  1. Advise the Secretary of State on use of powers provided by section 60 of the Health and Social Care Act 2001, and in particular on:
    • applications and proposals for use of these powers;
    • draft regulations made under s60(1) of the Act;
    • proposals to vary or revoke such regulations following the Secretary of State's required annual review of existing provisions.
  2. Advise the Secretary of State on key issues, particularly those of national significance, relating to the processing of patient information.

The advice of the PIAG must be published. Resulting regulations must be laid under affirmative process (debated in Parliament by each House).

Background

The Government has made it clear that informed consent is the fundamental principle governing the use of patient identifiable information by any part of the National Health Service (NHS) or research community. The NHS Plan proposed to develop a patient centred service where information is shared between all those involved in delivering or developing care presents an opportunity to make the best possible use of patient information. But the informed consent of patients must underwrite that objective. Alternatively, and this may be a better solution in many cases, information which no longer identifies individual patients must be used.

Ministers have taken a very public stand on the issue. In response to the Royal Liverpool Children's Inquiry they said that,

"The traditional paternalistic attitude of the NHS, that the benefits of science and research are somehow self-evident, was no longer acceptable."

The challenge to the NHS was twofold: to change the culture and to move to systems of using patient identifiable information based upon the informed consent of patients.

The law

Although this policy direction has an ethical basis, there are important legal considerations. Patients provide information about themselves in confidence and where information is held in confidence, common law provides no other reliable justification other than informed consent for use of the information in a patient identifiable form. Further, the NHS must comply with the Data Protection Act 1998 which requires certain information to be provided to patients and the Human Rights Act 1998 which subjects any invasion of the private life of an individual to a test of necessity. Guidance from the General Medical Council, the Medical Research Council, the British Medical Association and draft guidance from the Information Commissioner's Office reflect the evolving legal position and reinforce the requirement for consent.

The problem

There are also situations where informed consent cannot be obtained. For example, important research projects may involve tens of thousands of patients where contact would be impracticable. The essential nature of some of this research means that the public good outweighs issues of privacy. Some patients are not capable of giving consent, but the health service still needs to know about them and their conditions. Sometimes excluding those who refuse consent might bias data collection to the extent that it loses all value.

The solution

Section 60 of the Health and Social Care Act 2001 provides a power to ensure that patient identifiable information needed to support essential NHS activity can be used without the consent of patients. The power can only be used to support medical purposes that are in the interests of patients or the wider public, where consent is not a alternative and where anonymised information will not suffice. It is intended largely as a transitional measure whilst consent or anonymisation procedures are developed, and this is reinforced by the need to review each use of the power annually.

It is worth noting that the passage of the Health and Social Care Bill provided clear evidence of the strength of feeling, particularly within the House of Lords, about the perceived erosion of patient rights. PIAG's role, therefore, will be to scrutinise carefully applications to use patient identifiable information made under section 60 to ensure the criteria are met.

Clinical audit

The following statement on clinical audit appeared in the NHS Chief Executive's Bulletin for 6-12 August 2004 [ [http://www.publications.doh.gov.uk/cebulletin12august04.htm NHS Chief Executive's Bulletin for 6-12 August 2004] ] :

Following receipt of representations from a range of NHS organisations - including Cancer Networks, the Ambulance Service Association and Ambulance Trusts, the Patient Information Advisory Group met to review its previous decision on clinical audit that is not supported by explicit patient consent.

PIAG is now content for their existing ruling to be interpreted more flexibly. Therefore any clinical audit which involves the sharing of patient identifiable information would be acceptable providing that:

  1. the organisation has played a part in delivering care or treatment to that individual;
  2. the audit is carried out in accordance with clinical governance guidelines; and
  3. that it has been approved by the medical director and Caldicott Guardian for the trust in question.

The future of PIAG

The Health and Social Care Act 2008 [ [http://www.opsi.gov.uk/acts/acts2008/pdf/ukpga_20080014_en.pdf Health and Social Care Act 2008] ] will create the National Information Governance Board for Health and Social Care [ [http://www.connectingforhealth.nhs.uk/nigb National Information Governance Board for Health and Social Care] ] . It will subsume PIAG when it begins operating in April 2009 and will have the following general functions:

  1. to monitor the practice followed by relevant bodies in relation to the processing of relevant information,
  2. to keep the Secretary of State, and such bodies as the Secretary of State may designate by direction, informed about the practice being followed by relevant bodies in relation to the processing of relevant information,
  3. to publish guidance on the practice to be followed in relation to the processing of relevant information,
  4. to advise the Secretary of State on particular matters relating to the processing of relevant information by any person, and
  5. to advise persons who process relevant information on such matters relating to the processing of relevant information by them as the Secretary of State may from time to time designate by direction.

"relevant information" means -

  1. patient information,
  2. any other information obtained or generated in the course of the provision of the health service, and
  3. any information obtained or generated in the course of the exercise by a local social services authority in England of its adult social services functions.

References

External links

* [http://www.advisorybodies.doh.gov.uk/piag PIAG website]
* [http://www.ukacr.org Cancer Networks]
* [http://www.asa.uk.net Ambulance Service Association]
* [http://www.rlcinquiry.org.uk Royal Liverpool Children's Inquiry]
* [http://www.dh.gov.uk/en/Policyandguidance/Organisationpolicy/Modernisation/DH_4082690 NHS Plan]

* [http://www.dh.gov.uk/en/Policyandguidance/Informationpolicy/Patientconfidentialityandcaldicottguardians Department of Health: Patient confidentiality and access to health records]
* [http://www.dh.gov.uk/en/Policyandguidance/Informationpolicy/Patientconfidentialityandcaldicottguardians/DH_4100550 Department of Health: NHS confidentiality code of practice]
* [http://www.ico.gov.uk/upload/documents/library/data_protection/practical_application/health_data_-_use_and_disclosure001.pdf Information Commissioner: Use and disclosure of health data]
* [http://www.nres.npsa.nhs.uk National Research Ethics Service]


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