Health Identifiers Act 2014

Link to law: http://www.irishstatutebook.ie/2014/en/act/pub/0015/print.html

Health Identifiers Act 2014
Number 15 of 2014
HEALTH IDENTIFIERS ACT 2014
CONTENTS
PART 1
Preliminary and General
Section
1. Short title and commencement
2. Interpretation
3. Regulations
4. Expenses
PART 2
Individual Health Identifiers
5. Assignment of individual health identifier
6. Establishment and maintenance of National Register of Individual Health Identifiers
7. Use, etc., of other identifying particulars
8. Provision of other identifying particulars by Minister of Government
9. Information to be provided by an tArd-Chláraitheoir to Minister
10. Access to National Register of Individual Health Identifiers
11. Use of individual health identifier and National Register of Individual Health Identifiers
12. Use of individual health identifier, and accessing of National Register of Individual Health Identifiers, in another Member State
PART 3
Health Services Provider Identifiers
13. Assignment of health services provider identifier
14. Establishment and maintenance of National Register of Health Services Provider Identifiers
15. Information to be provided by professional regulatory bodies
16. Information to be provided by relevant bodies
17. Information to be provided by health practitioners and relevant bodies concerning relevant employees and relevant agents
18. Use of relevant particulars (health services provider) obtained by Minister
19. Access to National Register of Health Services Provider Identifiers
20. Use of health services provider identifier and National Register of Health Services Provider Identifiers
PART 4
Offences
21. Offences relating to assignment of individual health identifiers
22. Offences relating to accessing and processing
23. Offence for specified person to access National Register of Individual Health Identifiers purporting to be other specified person
24. Offences relating to assignment of health services provider identifiers
25. Offences by bodies corporate
PART 5
Delegation of Relevant Functions of Minister
26. Delegation of relevant functions of Minister
PART 6
Application of Data Protection Acts 1988 and 2003
27. Application of Data Protection Acts 1988 and 2003
PART 7
Miscellaneous
28. Investigations
29. Agreement to carry out certain activities
30. Verification
31. Data exchange agreements
32. Processing of personal data
33. Minister’s power to specify form of documents
34. Minister’s power to extend time
35. Amendment of Dentists Act 1985
36. Amendment of section 52 of Health and Social Care Professionals Act 2005
37. Amendment of section 35 of Pharmacy Act 2007
38. Amendment of section 57 of Medical Practitioners Act 2007
39. Amendment of section 55 of Nurses and Midwives Act 2011
SCHEDULE 1
Authorised Disclosees (Persons Who May Process Relevant Information (Individuals) for Particular Secondary Purposes)
SCHEDULE 2
Persons Who Fall within Paragraph (b) of Definition of “Specified Person” in Section 2(1)
Acts Referred to
Civil Registration Act 2004 (No. 3)
Data Protection (Amendment) Act 2003 (No. 6)
Data Protection Act 1988 (No. 25)
Data Protection Acts 1988 and 2003
Dentists Act 1985 (No. 9)
Health (Pricing and Supply of Medical Goods) Act 2013 (No. 14)
Health and Social Care Professionals Act 2005 (No. 27)
Health Insurance Act 1994 (No. 16)
Medical Practitioners Act 2007 (No. 25)
Nurses and Midwives Act 2011 (No. 41)
Opticians Act 1956 (No. 17)
Pharmacy Act 2007 (No. 20)
Social Welfare Consolidation Act 2005 (No. 26)
Number 15 of 2014
HEALTH IDENTIFIERS ACT 2014
An Act to provide for the assignment of a unique number to an individual to whom a health service is being, has been or may be provided; to provide for the assignment of a unique number to a person who provides a health service; to make provision for the establishment and maintenance of registers in respect of such numbers and other particulars of the individuals and other persons to whom the numbers are assigned; to make provision for the basis on which such registers may be accessed and the personal data contained therein may be processed; to provide for the delegation by order to the Health Service Executive of certain functions conferred on the Minister for Health; to provide for the consequential amendment of other enactments; and to provide for related matters. [8 th July, 2014]
Be it enacted by the Oireachtas as follows:
PART 1

Preliminary and General

Short title and commencement
1. (1) This Act may be cited as the Health Identifiers Act 2014.
(2) This Act shall come into operation on such day or days as may be appointed by order or orders made by the Minister, either generally or with reference to a particular purpose or provision, and different days may be so appointed for different purposes and different provisions.
(3) Without prejudice to the generality of subsection (2), an order under this section may appoint a day on which section 20 (1) shall come into operation in relation to a Part of the National Register of Health Services Provider Identifiers specified in the order in so far as that Part relates to a class of health services providers specified in the order whose relevant information (health services provider) is contained in that Part.

Interpretation
2. (1) In this Act—
“access”, in relation to a Register, includes to inspect the Register;
“Act of 2013” means the Health (Pricing and Supply of Medical Goods) Act 2013 ;
“authorised disclosee” means—
(a) a person specified in Schedule 1 , or
(b) subject to section 3 (3) and (8), a person, or a person who falls within a class of persons, prescribed for the purposes of this paragraph;
“conditions” includes terms;
“enactment” means an Act or statutory instrument or any portion of an Act or statutory instrument;
“equivalent person” shall be construed in accordance with section 12 (1);
“European act” means an act or provision of an act, adopted by an institution of the European Union, an institution of the European Communities or any other body competent under the treaties governing the European Union;
“Executive” means the Health Service Executive;
“health”, in relation to an individual, includes the well-being of the individual;
“health practitioner” means—
(a) a registered medical practitioner within the meaning of section 2 of the Medical Practitioners Act 2007 or a medical practitioner practising medicine pursuant to section 50 of that Act,
(b) a registered dentist within the meaning of section 2 of the Dentists Act 1985 ,
(c) a registered pharmacist or registered pharmaceutical assistant within the meaning of the Pharmacy Act 2007 ,
(d) a registered nurse or registered midwife within the meaning of section 2 (1) of the Nurses and Midwives Act 2011 ,
(e) a registered optometrist or registered dispensing optician within the meaning of section 2 of the Opticians Act 1956 ,
(f) a registrant within the meaning of section 3 (1) of the Health and Social Care Professionals Act 2005 ,
(g) a person whose name is entered in the register of pre-hospital emergency care practitioners established under the Pre-Hospital Emergency Care Council (Establishment) Order 2000 ( S.I. No. 109 of 2000 ), or
(h) a person who falls within a class of persons, being a class of persons who provide a health service, prescribed for the purposes of this paragraph;
“health service” means a health or personal social service (including personal care and any administrative service or other ancillary matter relating to the health or personal social service) provided to an individual—
(a) for—
(i) the screening, preservation or improvement of the health of the individual, or
(ii) the prevention, diagnosis, treatment or care of an illness or injury of the individual,
and
(b) by or under the direction of a health practitioner or relevant body;
“health services provider” means—
(a) a health practitioner who falls within a class of health practitioners prescribed for the purposes of this paragraph,
(b) a relevant body, or a relevant body which falls within a class of relevant bodies, prescribed for the purposes of this paragraph,
(c) a relevant employee of—
(i) a health practitioner referred to in paragraph (a), or
(ii) a relevant body referred to in paragraph (b),
(d) a relevant agent, who is an individual, of—
(i) a health practitioner referred to in paragraph (a), or
(ii) a relevant body referred to in paragraph (b),
or
(e) a relevant agent, who is not an individual, of—
(i) a health practitioner referred to in paragraph (a), or
(ii) a relevant body referred to in paragraph (b);
“health services provider identifier”, in relation to a health services provider, shall be construed in accordance with section 13 (1);
“identifier” means an individual health identifier or a health services provider identifier;
“individual health identifier”, in relation to an individual, shall be construed in accordance with section 5 (1);
“Minister” means the Minister for Health;
“National Register of Health Services Provider Identifiers” means the National Register of Health Services Provider Identifiers established and maintained under section 14 (1);
National Register of Individual Health Identifiers” means the National Register of Individual Health Identifiers established and maintained under section 6 (1);
“number” includes an alphanumeric number;
“other identifying particulars”, in relation to an individual, means any one or more of the following particulars:
(a) surname;
(b) forename;
(c) date of birth;
(d) place of birth;
(e) sex;
(f) all former surnames;
(g) mother’s surname and all former surnames of his or her mother (including mother’s surname at mother’s birth);
(h) address;
(i) nationality;
(j) personal public service number (if any) within the meaning of section 262 of the Social Welfare Consolidation Act 2005 ;
(k) date of death in the case of a deceased individual;
(l) signature (not being a signature which falls within a class of signatures prescribed as a class of signatures to which this paragraph does not apply);
(m) photograph (not being a photograph which falls within a class of photographs prescribed as a class of photographs to which this paragraph does not apply);
(n) subject to section 3 (8), any other particulars (excluding clinical information relating to the individual) prescribed for the purpose of this paragraph that, in the opinion of the Minister, are relevant to identifying the individual;
“personal data” has the meaning assigned to it by the Data Protection Act 1988 ;
“possession” includes control;
“prescribed” means prescribed by regulations made by the Minister;
“primary purpose” means the present, past or future provision of a health service to an individual;
“processing” has the meaning assigned to it by the Data Protection Act 1988 ;
“professional regulatory body” means—
(a) the Medical Council,
(b) the Dental Council,
(c) the Pharmaceutical Society of Ireland,
(d) the Nursing and Midwifery Board of Ireland,
(e) Bord na Radharcmhastóirí,
(f) a registration board established by or under the Health and Social Care Professionals Act 2005 ,
(g) the Pre-Hospital Emergency Care Council, or
(h) a body, being the regulatory body of a class of persons prescribed for the purposes of paragraph (h) of the definition of “health practitioner”, prescribed for the purposes of this paragraph;
“Register” means—
(a) the National Register of Individual Health Identifiers, or
(b) the National Register of Health Services Provider Identifiers;
“relevant agent”—
(a) in relation to a health practitioner referred to in paragraph (a) of the definition of “health services provider”, means an agent of the health practitioner in the health practitioner’s capacity as such and who falls within a class of such agents prescribed for the purposes of this paragraph, and
(b) in relation to a relevant body referred to in paragraph (b) of the definition of “health services provider”, means an agent of the relevant body in the relevant body’s capacity as such and who falls within a class of such agents prescribed for the purposes of this paragraph;
“relevant body” means—
(a) the Executive, or
(b) a body corporate, or an unincorporated body of persons, through which or in connection with which (whether by reason of employment or otherwise) a health practitioner, referred to in paragraph (a) of the definition of “health services provider”, provides a health service;
“relevant employee”—
(a) in relation to a health practitioner referred to in paragraph (a) of the definition of “health services provider”, means an employee of the health practitioner in the health practitioner’s capacity as such and who falls within a class of such employees prescribed for the purposes of this paragraph, and
(b) in relation to a relevant body referred to in paragraph (b) of the definition of “health services provider”, means an employee of the relevant body in the relevant body’s capacity as such and who falls within a class of such employees prescribed for the purposes of this paragraph;
“relevant information (health services provider)”, in relation to a health services provider, means—
(a) the provider’s health services provider identifier,
(b) some or all of the provider’s relevant particulars (health services provider) contained in the National Register of Health Services Provider Identifiers, or
(c) both the provider’s health services provider identifier and some or all of the provider’s relevant particulars (health services provider) contained in the National Register of Health Services Provider Identifiers;
“relevant information (individual) ”, in relation to an individual, means—
(a) the individual’s individual health identifier,
(b) some or all of the individual’s other identifying particulars contained in the National Register of Individual Health Identifiers, or
(c) both the individual’s individual health identifier and some or all of the individual’s other identifying particulars contained in the National Register of Individual Health Identifiers;
“relevant particulars (health services provider)”, in relation to a health services provider, means the provider’s particulars referred to in paragraph (a)(ii), (b)(ii), (c)(ii), (d)(ii) or (e)(ii), as appropriate, of subsection (1) of section 14 ;
“relevant purpose” means—
(a) a primary purpose, or
(b) a secondary purpose;
“secondary purpose” means—
(a) the promotion of patient safety, including clinical auditing and the investigation and reporting of patient safety incidents,
(b) the identification or prevention of a threat to public health,
(c) the management of health services, including—
(i) the planning, monitoring, delivery, improvement, auditing and evaluation of health services,
(ii) the investigation and resolution of complaints relating to health services, and
(iii) the management of national health systems,
(d) the carrying out of health research that is the subject of a research ethics approval (or any cognate expression) under an enactment or European act prescribed for the purposes of this paragraph,
(e) the performance of any function conferred on a person under this Act or another enactment for which the processing of identifiers is necessary,
(f) the provision of a scheme of health or health-related insurance operated by an undertaking authorised to so do under the Health Insurance Act 1994 , or
(g) any—
(i) processing of relevant information (individuals) required to protect or prevent injury or other damage to the health or safety of an individual,
(ii) processing of relevant information (individuals) required by or under an enactment, rule of law or equity or order of a court,
(iii) processing of relevant information (individuals) that is in accordance with the Data Protection Acts 1988 and 2003 and required for—
(I) the purposes of obtaining legal advice,
(II) the purposes of, or in the course of, legal proceedings, or
(III) the purposes of, or in the course of, alternative dispute resolution procedures agreed between a service provider and an individual as a means of resolving a dispute,
or
(iv) subject to section 3 (4) and (8), processing of relevant information (individuals) relating to health that is prescribed for the purposes of this subparagraph;
“specified person” means—
(a) a health services provider,
(b) a person specified in Schedule 2, or
(c) subject to section 3 (5) and (8),a person, or a person who falls within a class of persons, prescribed for the purposes of this paragraph.
(2) A reference in this Act to a Part of the National Register of Health Services Provider Identifiers shall be construed in accordance with section 14 (1).

Regulations
3. (1) The Minister may by regulations provide for any matter referred to in this Act as prescribed or to be prescribed.
(2) Without prejudice to any provision of this Act, regulations under this Act may contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of the regulations.
(3) Subject to subsection (9), the Minister shall not prescribe a person, or a class of persons, for the purposes of paragraph (b) of the definition of “authorised disclosee” in section 2 (1) unless the Minister is satisfied that it is in the public interest that that person, or a person who falls within that class of persons, as the case may be, be an authorised disclosee for the purposes of this Act.
(4) Subject to subsection (9), the Minister shall not prescribe a processing of relevant information (individuals) relating to health for the purposes of subparagraph (iv) of paragraph (g) of the definition of “secondary purpose” in section 2 (1) unless he or she is satisfied that it is in the public interest that that processing be a secondary purpose for the purposes of this Act.
(5) Subject to subsection (9), the Minister shall not prescribe a person, or a class of persons, for the purposes of paragraph (c) of the definition of “specified person” in section 2 (1) unless the Minister is satisfied that it is in the public interest that that person, or a person who falls within that class of persons, as the case may be, be a specified person for the purposes of this Act.
(6) Subject to subsection (9), the Minister shall not prescribe a class of specified persons and a class of relevant information (individuals) for the purposes of paragraph (b) of section 10 (2) unless he or she is satisfied that it is in the public interest that a specified person who falls within that class of specified persons not have access, pursuant to paragraph (a) of section 10 (2), to relevant information (individuals) that falls within that class of relevant information (individuals).
(7) (a) Subject to subsection (9), the Minister shall not prescribe a class of relevant information (individuals) to which paragraph (c) of section 11 (6) does not apply unless he or she is satisfied that it is in the public interest that that paragraph not apply to that class of relevant information (individuals).
(b) Subject to subsection (9), the Minister shall not prescribe a class of relevant information (individuals) to which paragraph (e) of section 11 (6) does not apply unless he or she is satisfied that it is in the public interest that that paragraph not apply to that class of relevant information (individuals).
(c) Subject to subsection (9), the Minister shall not prescribe a class of secondary purposes to which paragraph (e) of section 11 (6) does not apply unless he or she is satisfied that it is in the public interest that that paragraph not apply to that class of secondary purposes.
(8) The Minister may, after consultation with the Data Protection Commissioner—
(a) prescribe a person, or a class of persons, for the purposes of paragraph (b) of the definition of “authorised disclosee” in section 2 (1),
(b) prescribe particulars for the purposes of paragraph (n) of the definition of “other identifying particulars” in section 2 (1),
(c) prescribe a processing of relevant information (individuals) relating to health for the purposes of subparagraph (iv) of paragraph (g) of the definition of “secondary purpose” in section 2 (1),
(d) prescribe a person, or a class of persons, for the purposes of paragraph (c) of the definition of “specified person” in section 2 (1),
(e) prescribe a class of persons and a class of relevant information (individuals) for the purposes of paragraph (b) of section 10 (2),
(f) prescribe a class of relevant information (individuals) to which paragraph (c) of section 11(6) does not apply, or
(g) prescribe a class of relevant information (individuals) or a class of secondary purposes to which paragraph (e) of section 11 (6) does not apply, or both.
(9) When determining whether or not a matter referred to in subsection (3), (4), (5), (6) or (7) is in the public interest, the Minister shall have due regard to protecting the privacy of individuals and securing the effective achievement of one or more than one relevant purpose.
(10) Every regulation made under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the regulation is passed by either such House within the next 21 days on which that House sits after the regulation is laid before it, the regulation shall be annulled accordingly, but without prejudice to the validity of anything previously done under the regulation.

Expenses
4. The expenses incurred by the Minister or any other Minister of the Government in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Public Expenditure and Reform, be paid out of moneys provided by the Oireachtas.
PART 2

Individual Health Identifiers

Assignment of individual health identifier
5. (1) Subject to subsection (2), the Minister may assign a unique number (in this Act referred to as an “individual health identifier”) to—
(a) a living individual (whether or not the individual is ordinarily resident in the State) to whom a health service is being, has been or may be provided, or
(b) an individual who dies on or after the coming into operation of this section without having been assigned such number as a living individual.
(2) An individual health identifier shall, other than itself, contain no personal data.
(3) The assigning of an individual health identifier to an individual shall not be regarded in any way as indicating, in and of itself, an entitlement to, or eligibility for, the provision of a health service to the individual.
(4) (a) The Minister mayput in place measures, or cause to be put in place measures, that the Minister considers appropriate to assist in enabling an individual’s individual health identifier to be made known to him or her (or, in the case of a deceased individual, to be made known to the individual’s personal representative).
(b) Where an individual who has an individual health identifier may require the assistance of another person to obtain a health service (whether due to the age or lack of capacity of the individual or for any other reason), the Minister may put in place measures, or cause to be put in place measures, that the Minister considers appropriate to assist in enabling that identifier to be made known to that other person.
(5) The Minister may, for the purposes of any measures referred to in subsection (4), consult with such persons as he or she considers appropriate.

Establishment and maintenance of National Register of Individual Health Identifiers
6. (1) The Minister shall establish and maintain a register, to be known as the National Register of Individual Health Identifiers, containing, in relation to each individual who has been assigned an individual health identifier—
(a) the individual health identifier, and
(b) such of the individual’s other identifying particulars as are known.
(2) No personal data relating to an individual, other than personal data referred to in subsection (1), shall be contained in the National Register of Individual Health Identifiers.
(3) A deceased individual’s relevant information (individual) may continue to be contained in the National Register of Individual Health Identifiers whether or not the individual was assigned his or her identifier under section 5 (1)(a) or (b), and the Minister shall, in any such case where the Minister becomes aware of such death, cause a notation, indicating that the individual is deceased and the date of the individual’s death, to be entered in the Register in relation to the individual’s individual health identifier.

Use, etc., of other identifying particulars
7. (1) For the purposes of assigning an individual health identifier to an individual, or for establishing and maintaining the National Register of Individual Health Identifiers, the Minister may use any of the individual’s other identifying particulars obtained by him or her or the Executive (whether before or after the coming into operation of this section).
(2) For the purposes of enabling the assigning of individual health identifiers to individuals, a health services provider who provides, or has provided, or is proposing to provide, a health service to an individual may—
(a) subject to paragraph (b), request the individual (or, in the case of a deceased individual, the individual’s personal representative) to provide the provider with the individual’s other identifying particulars, or
(b) in the case of an individual who may require the assistance of another person to obtain a health service (whether due to the age or lack of capacity of the individual or for any other reason), request the other person to provide the provider with the individual’s other identifying particulars.
(3) An individual (or personal representative) or other person who receives a request referred to in subsection (2) shall, if one or more of the individual’s other identifying particulars are known to him or her, comply with the request as soon as is reasonably practicable to the extent that such particulars are so known.
(4) A health services provider shall, not later than 30 days after being provided with the individual’s other identifying particulars pursuant to subsection (3), provide the Minister with such particulars.
(5) Where a health services provider has, pursuant to subsection (4), provided the Minister with the individual’s other identifying particulars and it subsequently comes to the attention of the provider that any of those particulars were not, or are no longer, accurate, he or she shall, not later than 30 days after the inaccurate information concerned comes to his or her attention, give the Minister a notice—
(a) stating particulars of the inaccurate information, and
(b) if known to the provider, stating the correct other identifying particulars which should replace the inaccurate information.
(6) Subsection (5) shall, with all necessary modifications, apply to other identifying particulars provided to the Minister pursuant to paragraph (b) of that subsection as that subsection applies to other identifying particulars provided to the Minister pursuant to subsection (4) .

Provision of other identifying particulars by Minister of Government
8. A Minister of the Government may, solely for the purpose of establishing, or maintaining the accuracy of, the National Register of Individual Health Identifiers, provide the Minister with an individual’s other identifying particulars and the Minister may use any such particulars so provided for that purpose.

Information to be provided by an tArd-Chláraitheoir to Minister
9. (1) For the purpose of assisting the Minister to perform his or her functions under this Act, an tArd-Chláraitheoir shall provide the Minister with an individual’s other identifying particulars, relating to the registration of the individual’s birth or death, as soon as is reasonably practicable after an tArd-Chláraitheoir collects such particulars.
(2) Section 66 (1) of the Civil Registration Act 2004 is amended by inserting the following after paragraph (g):
“(ga) the Minister for the purpose of enabling him or her to perform his or her functions under the Health Identifiers Act 2014,”.

Access to National Register of Individual Health Identifiers
10. (1) The Minister may access the National Register of Individual Health Identifiers for—
(a) a relevant purpose, or
(b) the purpose of performing a function conferred on him or her by this Act or another enactment.
(2) (a) Subject to paragraph (b), a specified person may access the National Register of Individual Health Identifiers for a relevant purpose.
(b) Subject to section 3 (6) and (8), a specified person who falls within a class of specified persons prescribed for the purposes of this paragraph (which may be all specified persons) shall not, pursuant to paragraph (a), access the National Register of Individual Health Identifiers in so far as the Register contains any relevant information (individuals) that falls within a class of relevant information (individuals) prescribed for the purposes of this paragraph as a class of relevant information (individuals) which may not be so accessed by that class of specified persons.
(3) An equivalent person may access the National Register of Individual Health Identifiers in accordance with an agreement made under section 12 .
(4) For the purposes of this section, the Minister shall put in place measures, or cause to be put in place measures—
(a) to enable the National Register of Individual Health Identifiers to be accessed in accordance with subsection (1), (2) or (3), and
(b) to assist in ensuring that the National Register of Individual Health Identifiers—
(i) is not accessed otherwise than in accordance with subsection (1), (2) or (3), and
(ii) is not accessible by any person other than the Minister accessing the Register in accordance with subsection (1), a specified person accessing the Register in accordance with subsection (2) or an equivalent person accessing the Register in accordance with subsection (3).

Use of individual health identifier and National Register of Individual Health Identifiers
11. (1) A health services provider shall, when providing a health service to an individual on or after the coming into operation of this subsection—
(a) subject to paragraph (b), request the individual to provide his or her individual health identifier (if any) to the provider, or
(b) in the case of an individual who may require the assistance of another person to provide the individual’s individual health identifier (if any) to the provider (whether due to the age or lack of capacity of the individual or for any other reason), request the other person to provide the individual’s individual health identifier to the provider.
(2) Where a health services provider is provided with an individual’s individual health identifier pursuant to subsection (1), or where the provider is able to establish the individual’s individual health identifier by virtue of the other identifying particulars provided to the provider by the individual or another person pursuant to a request of the provider, the provider shall—
(a) associate that identifier with the record that the provider makes, or causes to be made, of the provision of the health service concerned, and
(b) indicate that identifier in any relevant communication.
(3) Without prejudice to the generality of section 7 (2)to (6), an individual to whom a health service is provided by a health services provider, or who seeks to have a health service provided to him or her by a health services provider, shall give his or her individual health identifier to the provider when requested to do so by the provider if—
(a) the individual has an individual health identifier, and
(b) the individual health identifier is known to the individual.
(4) A health services provider shall not refuse to provide a health service to an individual, to which he or she would otherwise be entitled, solely because—
(a) an individual health identifier has not been assigned to the individual,
(b) the individual cannot or refuses to provide his or her individual health identifier,
(c) the individual cannot or refuses to provide other identifying particulars in accordance with a request under section 7 (2) or subsection (2), or
(d) the provider does not have access to the National Register of Individual Health Identifiers at the time when the individual is seeking to obtain the health service.
(5) Where paragraph (a), (b), (c) or (d) of subsection (4) applies, the health services provider shall make a note of that fact in the record that the provider makes, or causes to be made, of the provision of the health service concerned.
(6)(a) The Minister may, for a relevant purpose or for the purpose of performing a function conferred on him or her by this Act or another enactment, process or further process an individual’s relevant information (individual), including by providing such information to a specified person in order to enable the specified person to process such information for a relevant purpose.
(b) The Minister may provide an individual’s relevant information (individual) to an authorised disclosee in order to enable the authorised disclosee to process that information for a secondary purpose.
(c) Subject to paragraph (d), a specified person may, for a relevant purpose, process or further process an individual’s relevant information (individual) that the specified person has obtained pursuant to, and in accordance with, a provision of this Act, including by providing such information to the Minister or another specified person in order to enable the Minister or other specified person, as the case may be, to process the relevant information (individual) for a relevant purpose.
(d) Subject to section 3 (7)(a) and (8), paragraph (c) does not apply to any relevant information (individuals) that falls within a class of relevant information (individuals) prescribed as a class of relevant information (individuals) to which that paragraph does not apply.
(e) Subject to paragraph (f) a specified person may provide an individual’s relevant information (individual) that the specified person has obtained pursuant to, and in accordance with, a provision of this Act to an authorised disclosee in order to enable the authorised disclosee to process the relevant information (individual) for a secondary purpose.
(f) Subject to section 3 (7)(b) and (c) and (8), paragraph (e) does not apply to any, or any combination, of the following:
(i) any relevant information (individuals) that falls within a class of relevant information (individuals) prescribed as a class of relevant information (individuals) to which that paragraph does not apply;
(ii) a secondary purpose that falls within a class of secondary purposes prescribed as a class of secondary purposes to which that paragraph does not apply.
(7) In this section “relevant communication”, in relation to a health services provider and an individual, means a communication—
(a) relating to a relevant purpose, and
(b) sent by the provider to—
(i) the Minister,
(ii) another specified person,
(iii) an authorised disclosee, or
(iv) the individual.

Use of individual health identifier, and accessing of National Register of Individual Health Identifiers, in another Member State
12. (1) (a) The Minister may, where he or she considers it appropriate to do so in the interests of individuals who have been assigned individual health identifiers and who are being provided, in another Member State, with a service that, in the opinion of the Minister, is the equivalent, in that other Member State, of a health service within the meaning of section 2 (1), enter into an agreement to which this section applies.
(b) This section applies to an agreement between the Minister and a person who, in the opinion of the Minister, is the equivalent (in this Act referred to as the “equivalent person”), in the other Member State, of a health services provider referred to in paragraph (a) or (b) of the definition of “health services provider” in section 2 (1), for the purpose of allowing the equivalent person to obtain and use an individual health identifier, and to access the National Register of Individual Health Identifiers, on or after the coming into operation of section 11 (1), in so far as any such accessing relates to an individual referred toin paragraph (a).
(2) An agreement made under this section shall specify all the matters that the Minister considers appropriate to the processing of an individual’s relevant information (individual), or the accessing of the National Register of Individual Health Identifiers, by the equivalent person and, without prejudice to the generality of the foregoing, shall include the following:
(a) the name, address and other contact details of the equivalent person;
(b) the name and other contact details of the person nominated by the equivalent person as the person to whom any queries in relation to the agreement can be made;
(c) the specific activities for which the equivalent person can process an individual’s relevant information (individual) or access the National Register of Individual Health Identifiers;
(d) the measures that the equivalent person is to put in place, or cause to be put in place, that are the equivalent, in the other Member State concerned, of measures referred to in subsection (4) of section 10 in so far as paragraph (b) of that subsection is concerned; and
(e) the sanction that is provided for any breach of the agreement by the equivalent person.
(3) The Minister shall not make an agreement under this section except after consultation with the Data Protection Commissioner.
(4) The Data Protection Commissioner may, at any time, review the operation of an agreement made under this section and, where he or she does so, shall make a report to the Minister on his or her findings, and the Minister shall take such action as he or she considers appropriate arising from that report.
PART 3

Individual Health Identifiers

Assignment of health services provider identifier
13. (1) Subject to subsections (2)and (3), the Minister may assign a unique number (in this Act referred to as a “health services provider identifier”) to a health services provider.
(2) Where a health services provider falls within each of paragraphs (b) and (e) of the definition of “health services provider” in section 2 (1), the Minister may assign the same health services provider identifier to the provider in both its capacity as a relevant body and its capacity as a relevant agent.
(3) Subject to subsection (4), a health services provider identifier assigned to an individual shall, other than itself, contain no personal data.
(4) Where a health services provider falls within paragraph (a) of the definition of “health services provider” in section 2 (1), the Minister may assign a health services provider identifier to the provider which indicates which class of health practitioners that the provider falls within.

Establishment and maintenance of National Register of Health Services Provider Identifiers
14. (1) The Minister shall establish and maintain a register, to be known as the National Register of Health Services Provider Identifiers, consisting of Parts A, B, C, D and E and containing—
(a) in Part A of the Register, in relation to each health practitioner referred to in paragraph (a) of the definition of “health services provider” in section 2 (1) who has been assigned a health services provider identifier—
(i) the health services provider identifier, and
(ii) the following particulars to the extent that they are known:
(I) surname;
(II) forename;
(III) business address and, if different, the place of employment and name of employer;
(IV) the name of the professional regulatory body with which the practitioner is registered and the registration number assigned to the practitioner by that body;
(V) subject to subsection (2), any other particulars prescribed for the purposes of this clause that, in the opinion of the Minister, are relevant to identifying the practitioner,
(b) in Part B of the Register, in relation to each relevant body referred to in paragraph (b) of the definition of “health services provider” in section 2 (1) which has been assigned a health services provider identifier—
(i) the health services provider identifier, and
(ii) the following particulars to the extent that they are known:
(I) its legal name and, where applicable, the name under which it trades;
(II) its business address;
(III) the locations at which it provides health services and a description of those services;
(IV) any other particulars prescribed for the purposes of this clause that, in the opinion of the Minister, are relevant to identifying the body and the health services it provides,
(c) in Part Cof the Register, in relation to a relevant employee referred to in paragraph (c) of the definition of “health services provider” in section 2 (1) who has been assigned a health services provider identifier—
(i) the health services provider identifier, and
(ii) the following particulars to the extent that they are known:
(I) surname;
(II) forename;
(III) the capacity in which he or she is a relevant employee, the place at which he or she is employed as a relevant employee and the name and health services provider identifier of the health services provider who is his or her employer;
(IV) subject to subsection (2), any other particulars prescribed for the purposes of this clause that, in the opinion of the Minister, are relevant to identifying the relevant employee,
(d) in Part D of the Register, in relation to each relevant agent referred to in paragraph (d) of the definition of “health services provider” in section 2 (1) who has been assigned a health services provider identifier—
(i) the health services provider identifier, and
(ii) the following particulars to the extent that they are known:
(I) surname;
(II) forename;
(III) the capacity in which he or she is a relevant agent, the place at which he or she acts as a relevant agent and the name and health services provider identifier of the health services provider who is the relevant agent’s principal;
(IV) subject to subsection (2), any other particulars prescribed for the purposes of this clause that, in the opinion of the Minister, are relevant to identifying the relevant agent,
and
(e) in Part Eof the Register, in relation to a relevant agent referred to in paragraph (e) of the definition of “health services provider” in section 2 (1) which has been assigned a health services provider identifier—
(i) the health services provider identifier, and
(ii) the following particulars to the extent that they are known:
(I) its legal name and, where applicable, the name under which it trades;
(II) its business address;
(III) the capacity in which it is a relevant agent, the place at which it acts as a relevant agent and the name and health services provider identifier of the health services provider who is the relevant agent’s principal;
(IV) any other particulars prescribed for the purposes of this clause that, in the opinion of the Minister, are relevant to identifying the relevant agent.
(2) The Minister shall not exercise his or her power to prescribe particulars referred to in subsection (1) (a)(ii)(V), (c)(ii)(IV) or (d)(ii)(IV) except after consultation with the Data Protection Commissioner.
(3) Where a health services provider who has been assigned a health services provider identifier ceases to be a health services provider (including any case where a health services provider who is an individual dies), the former health services provider’s relevant information (health service provider) may continue to be contained in the National Register of Health Services Provider Identifiers and the Minister shall, in any such case where the Minister becomes aware of such cesser, cause a notation, indicating that the health services provider has ceased to be a health services provider and the date of the cesser concerned, to be entered in the Register in relation to the former health services provider’s health services provider identifier.

Information to be provided by professional regulatory bodies
15. (1) A professional regulatory body shall, not later than 3 months after the date on which a class of health practitioners for which it is such body falls within paragraph (a) of the definition of “health services provider” in section 2 (1), provide the Minister with all of the relevant particulars (health services provider) that it has in its possession in respect of each health practitioner who falls within that class.
(2) A professional regulatory body which has complied with subsection (1) in respect of a class of health practitioners for which it is such body shall, not later than 30 days after the date on which a health practitioner falls within that class subsequent to such compliance, provide the Minister with all of the relevant particulars (health services provider) that it has in its possession in respect of that practitioner.
(3) Where a professional regulatory body has, pursuant to subsection (1) or (2), provided the Minister with any relevant particulars (health services provider) and it subsequently comes to the attention of the body that any of those particulars were not, or are no longer, accurate (including any case where a health practitioner registered with the body ceases to be so registered, whether by reason of the death of the practitioner or for any other reason), the body shall, not later than 30 days after the inaccurate information concerned comes to its attention, give the Minister a notice—
(a) stating particulars of the inaccurate information, and
(b) if known to the regulatory body, stating the correct relevant particulars (health services provider) which should replace the inaccurate information.
(4) Subsection (3) shall, with all necessary modifications, apply to relevant particulars (health services provider) provided to the Minister pursuant to paragraph (b) of that subsection as that subsection applies to relevant particulars (health services provider) provided to the Minister pursuant to subsection (1) or (2).

Information to be provided by relevant bodies
16. (1) A relevant body shall, not later than 3 months after the date on which it falls within paragraph (b) of the definition of “health services provider”, provide the Minister with its relevant particulars (health services provider).
(2) Where a relevant body has, pursuant to subsection (1), provided the Minister with its relevant particulars (health services provider) and it subsequently comes to the attention of the body that any of those particulars were not, or are no longer, accurate, the body shall, not later than 30 days after the inaccurate information concerned comes to its attention, give the Minister a notice—
(a) stating particulars of the inaccurate information, and
(b) stating its correct relevant particulars (health services provider) which should replace the inaccurate information.
(3) Subsection (2) shall, with all necessary modifications, apply to relevant particulars (health services provider) provided to the Minister pursuant to paragraph (b) of that subsection as that subsection applies to relevant particulars (health services provider) provided to the Minister pursuant to subsection (1) .

Information to be provided by health practitioners and relevant bodies concerning relevant employees and relevant agents
17. (1) A health practitioner referred to in paragraph (a) of the definition of “health services provider” in section 2 (1) shall, not later than 3 months after the date on which he or she is assigned a health services provider identifier in his or her capacity as such practitioner—
(a) provide the Minister with—
(i) in relation to each relevant employee (if any) of the practitioner, all of the employee’s relevant particulars (health services provider) that the practitioner has in his or her possession, and
(ii) in relation to each relevant agent (if any) of the practitioner, all of the agent’s relevant particulars (health services provider) that the practitioner has in his or her possession,
or
(b) if the practitioner does not have any relevant employees or relevant agents, provide the Minister with confirmation of that fact.
(2) A health practitioner referred to in paragraph (a) of the definition of “health services provider” in section 2 (1) who has complied with subsection (1) shall, not later than 30 days after the date on which a person becomes a relevant employee or relevant agent of the practitioner subsequent to such compliance, provide the Minister with all of the employee’s or the agent’s, as the case may be, relevant particulars (health services provider) that the practitioner has in his or her possession.
(3) A relevant body referred to in paragraph (b) of the definition of “health services provider” in section 2 (1) shall, not later than 3 months after the date on which it is assigned a health services provider identifier in its capacity as such body—
(a) provide the Minister with—
(i) in relation to each relevant employee (if any) of the body, all of the employee’s relevant particulars (health services provider) that the body has in its possession, and
(ii) in relation to each relevant agent (if any) of the body, all of the agent’s relevant particulars (health services provider) that the body has in its possession,
or
(b) if the body does not have any relevant employees or relevant agents, provide the Minister with confirmation of that fact.
(4) A relevant body referred to in paragraph (b) of the definition of “health services provider” in section 2 (1) which has complied with subsection (3) shall, not later than 30 days after the date on which a person becomes a relevant employee or relevant agent of the body subsequent to such compliance, provide the Minister with all of the employee’s or agent’s, as the case may be, relevant particulars (health services provider) that the body has in its possession.
(5) Where a health services provider has, pursuant to subsection (1), (2), (3) or (4), provided the Minister with any relevant particulars (health services provider) and it subsequently comes to the attention of the provider that any of those particulars were not, or are no longer, accurate (including any case where a relevant employee or relevant agent of the provider ceases to be such employee or agent, as the case may be), the provider shall, not later than 30 days after the inaccurate information concerned comes to his or her attention, give the Minister a notice—
(a) stating particulars of the inaccurate information, and
(b) if known to the provider, stating the correct relevant particulars (health services provider) which should replace the inaccurate information.
(6) Subsection (5) shall, with all necessary modifications, apply to relevant particulars (health services provider) provided to the Minister pursuant to paragraph (b) of that subsection as that subsection applies to relevant particulars (health services provider) provided to the Minister pursuant to subsection (1), (2), (3) or (4).
(7) Where a health services provider has, pursuant to subsection (1)(b) or (3)(b), confirmed that he or she does not have any relevant employees or relevant agents and it subsequently comes to the attention of the provider that the confirmation was not, or is no longer, accurate, the provider shall, not later than 30 days after the inaccurate information concerned comes to his or her attention, give the Minister a notice—
(a) stating particulars of the inaccurate information, and
(b) stating the relevant particulars (health services provider) of the provider’s relevant employees (if any) and relevant agents (if any) that are in the provider’s possession.
(8) Subsection (5) shall, with all necessary modifications, apply to relevant particulars (health services provider) provided to the Minister pursuant to paragraph (b) of subsection (7) as subsection (5) applies to relevant particulars (health services provider) provided to the Minister pursuant to subsection (1), (2), (3) or (4).

Use of relevant particulars (health services provider) obtained by Minister
18. The Minister may use any relevant particulars (health services provider) obtained by him or her or the Executive (whether before or after the coming into operation of this section) for the purposes of assigning a health services provider identifier to a health services provider and the establishment and maintenance of the National Register of Health Services Provider Identifiers.

Access to National Register of Health Services Provider Identifiers
19. (1) Any person may access the National Register of Health Services Provider Identifiers.
(2) For the purposes of this section, the Minister shall put in place measures, or cause to be put in place measures, to enable the National Register of Health Services Provider Identifiers to be accessed.

Use of health services provider identifier and National Register of Health Services Provider Identifiers
20. (1) Subject to subsection (2), a health services provider who has been issued a health services provider identifier shall, on and after the coming into operation of this subsection for that Part of the National Register of Health Services Provider Identifiers in which the provider’s relevant information (health services provider) is contained—
(a) associate that identifier with the record that he or she makes, or causes to be made, of the provision by the provider of a health service to an individual, and
(b) indicate that identifier in any relevant communication.
(2) Subsection (1) does not apply in circumstances where a health services provider who is a health practitioner is required by or under another enactment to use a registration number assigned to him or her by a professional regulatory body in the provision of the health service or relevant communication concerned.
(3) In this section “relevant communication”, in relation to a health services provider and an individual, means a communication—
(a) relating to a relevant purpose, and
(b) sent by the provider to—
(i) the Minister,
(ii) another specified person,
(iii) an authorised disclosee, or
(iv) the individual.
PART 4

Offences

Offences relating to assignment of individual health identifiers
21. (1) A person shall be guilty of an offence if, for the purposes of the assigning of an individual health identifier to him or her or to another person—
(a) he or she makes a statement or representation, whether orally or in writing, that is false or misleading in a material particular, knowing the statement or representation, as the case may be, to be so false or misleading or being reckless as to whether it is so false or misleading,
(b) he or she conceals a material fact, or
(c) he or she gives, or causes or knowingly allows to be given, any information, in purported compliance with a provision of this Act, that is false or misleading in a material particular, knowing the information to be so false or misleading or being reckless as to whether it is so false or misleading.
(2) A person guilty of an offence under subsection (1) shall be liable—
(a) on summary conviction, to a class B fine, or
(b) on conviction on indictment, to a fine not exceeding €100,000.

Offences relating to accessing and processing
22. (1) A person shall not access the National Register of Individual Health Identifiers except pursuant to, and in accordance with, a provision of this Act or another enactment.
(2) A person shall not process an individual’s individual health identifier (not being the individual health identifier of that person) for a purpose other than a relevant purpose.
(3) A person who knowingly contravenes subsection (1) or (2) shall be guilty of an offence and shall be liable—
(a) on summary conviction, to a class B fine, or
(b) on conviction on indictment, to a fine not exceeding €100,000.

Offence for specified person to access National Register of Individual Health Identifiers purporting to be other specified person
23. (1) A specified person shall not access the National Register of Individual Health Identifiers by the use of a means which purports to identify the specified person as a different specified person.
(2) A specified person who accesses the National Register of Individual Health Identifiers in contravention of subsection (1) shall be guilty of an offence and shall be liable on summary conviction to a class B fine.

Offences relating to assignment of health services provider identifiers
24. (1) A person shall be guilty of an offence if, for the purposes of the assigning of a health services provider identifier to him or her or to another person—
(a) he or she makes a statement or representation, whether orally or in writing, that is false or misleading in a material particular, knowing the statement or representation, as the case may be, to be so false or misleading or being reckless as to whether it is so false or misleading,
(b) he or she conceals a material fact, or
(c) he or she gives, or causes or knowingly allows to be given, any information, in purported compliance with a provision of this Act, that is false or misleading in a material particular, knowing the information or be so false or misleading or being reckless as to whether it is so false or misleading.
(2) A person guilty of an offence under subsection (1) shall be liable—
(a) on summary conviction, to a class B fine, or
(b) on conviction on indictment, to a fine not exceeding €100,000.

Offences by bodies corporate
25. (1) Where an offence under this Act is committed by a body corporate and it is proved that the offence was committed with the consent or connivance, or was attributable to any wilful neglect, of a person who was a director, manager, secretary or other officer of the body corporate, or a person purporting to act in that capacity, that person, as well as the body corporate, shall be guilty of an offence and may be proceeded against and punished as if he or she were guilty of the first-mentioned offence.
(2) Where the affairs of a body corporate are managed by its members, subsection (1) applies in relation to the acts and defaults of a member in connection with his or her functions of management as if he or she were a director or manager of the body corporate.
PART 5

Delegation of Relevant Functions of Minister

Delegation of relevant functions of Minister
26. (1) The Government may by order delegate to the Executive any or all of the Minister’s relevant functions (not being an excluded function).
(2) Where a delegation is made under subsection (1) —
(a) the Government may at any time by order revoke the delegation in whole or in part,
(b) subject to paragraph (a), the delegation shall operate, so long as it continues in force, to confer on and vest in the Executive each relevant function delegated by the delegation,
(c) a relevant function delegated by the delegation shall be performed by the Executive subject to any conditions stated in the order concerned under this section,
(d) any obligation or liability undertaken by the Executive consequent upon the performance by the Executive of a relevant function to which the delegation relates shall be of the same force and effect as if the obligation or liability, as the case may be, had been undertaken by the Minister,
(e) a relevant function of the Minister delegated by the delegation shall, notwithstanding the delegation, continue to be vested in the Minister but shall be so vested concurrently with the Executive and so as to be capable of being performed by either the Minister or the Executive,
(f) the delegation shall not remove or derogate from the responsibility of the Minister to Dáil Éireann or as a member of the Government for the performance of the relevant functions of the Minister thereby delegated, and
(g) the Executive shall, by virtue of this paragraph and notwithstanding any other enactment, have the power to perform each relevant function delegated by the delegation in accordance with any conditions stated in the order concerned under this section.
(3) The Government may by order amend or revoke an order under this section including an order under this subsection.
(4) An order under this section shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the order is passed by either such House within the next 21 days on which that House sits after the order is laid before it, the order shall be annulled accordingly, but without prejudice to the validity of anything previously done under the order.
(5) In this section—
“excluded function” means the Minister’s function under section 12 or to make regulations;
“relevant function” means a function of the Minister under—
(a) this Act (including any function of the Minister as a recipient of information),
(b) section 38(10) (amended by section 35 ) of the Dentists Act 1985 ,
(c) section 66(1)(ga) (amended by section 9 ) of the Civil Registration Act 2004 ,
(d) section 52(3A) (amended by section 36 ) of the Health and Social Care Professionals Act 2005 ,
(e) section 35(3A) (amended by section 37 ) of the Pharmacy Act 2007 ,
(f) section 57(1A) (amended by section 38 ) of the Medical Practitioners Act 2007 , or
(g) section 55(1A) (amended by section 39 ) of the Nurses and Midwives Act 2011 .
PART 6

Application of Data Protection Acts 1988 and 2003

Application of Data Protection Acts 1988 and 2003
27. (1) (a) A living individual’s individual health identifier held by a person to whom this paragraph applies shall be considered personal data for the purposes of the Data Protection Acts 1988 and 2003.
(b) Paragraph (a) applies to—
(i) the Minister,
(ii) a specified person, and
(iii) the Executive in its capacity (if any) as a delegatee under a delegation made under section 26 .
(2) For the avoidance of doubt, subsection (1) shall not be construed to prevent a living individual’s individual health identifier held by a person other than a person to whom paragraph (a) of that subsection applies from being personal data in accordance with the provisions of the Data Protection Acts 1988 and 2003.
(3) Sections 2(1) (d) (inserted by section 3 of the Data Protection (Amendment) Act 2003 ) and 2C (inserted by section 4 of the Data Protection (Amendment) Act 2003 ) of the Data Protection Act 1988 shall apply to a deceased individual’s relevant information (individual) as those sections apply to a living individual’s relevant information (individual).
PART 7

Miscellaneous

Investigations
28. (1) The Minister may cause such investigations to be carried out in respect of the operation of any provisions of this Act, and reports in writing made to him or her in respect of such investigations, as he or she considers reasonable and necessary for the proper monitoring of the assignment and use of identifiers.
(2) A specified person, professional regulatory body, authorised disclosee and the Executive shall co-operate with a person carrying out an investigation referred to in subsection (1) in so far as such co-operation relates to the investigation.

Agreement to carry out certain activities
29. The Minister may enter into an agreement with a person, upon such conditions as may be specified in the agreement, to provide for the performance by that person of services to enable the Minister to perform one or more than one of his of her functions under this Act.

Verification
30. (1) For the purposes of performing functions under this Act, the Minister may carry out, or cause to be carried out, such measures as he or she considers necessary to—
(a) verify any information provided to him or her under this Act other than information provided under section 8 or 9, or
(b) establish the efficient and effective operation of the Registers.
(2) Any person who provided, or is required to provide, information under this Act shall co-operate with the Minister in any measures undertaken under subsection (1)(a) in so far as such measures relate to such information.

Data exchange agreements
31. (1) For the purposes of this Act, there may be entered into, between the Minister and a relevant body, relevant agent, professional regulatory body, health practitioner or person who falls within paragraph (b) or (c) of the definition of “specified person” in section 2 (1), an agreement (in this section referred to as a “data exchange agreement”) specifying the procedures to be followed by each party to the agreement with respect to the provision of personal data between them for such of those purposes to which the agreement relates.
(2) A data exchange agreement may be varied by the parties to the agreement.
(3) The Minister shall consult with the Data Protection Commissioner in relation to a data exchange agreement before it is entered into or varied.

Processing of personal data
32. Any processing of personal data by the Minister for the purposes of the performance of his or her functions under this Act, or by the Executive for the purposes of the performance by it of its relevant functions the subject of a delegation under section 26 , shall go no further than is reasonably necessary for the performance of those functions.

Minister’s power to specify form of documents
33. (1) The Minister may specify the form of any documents required for the purposes of this Act as he or she thinks fit, including the form in which any information (howsoever described), notice or confirmation which is required to be, or which may be, provided to the Minister pursuant to a provision of this Act shall be so provided.
(2) The Minister’s power under subsection (1) may be exercised in such a way as to—
(a) include in the specified form of any document referred to in that subsection a statutory declaration—
(i) to be made by the person completing the form, and
(ii) as to whether the particulars contained in the form are true and correct to the best of that person’s knowledge and belief,
and
(b) specify 2 or more forms of any document referred to in that subsection, whether as alternatives, or to provide for particular circumstances or particular cases, as the Minister thinks fit.
(3) The form of a document specified under this section shall be—
(a) completed in accordance with such directions and instructions as are specified in the document,
(b) accompanied by such other documents as are specified in the document, and
(c) if the completed document is required to be provided to—
(i) the Minister,
(ii) another person on behalf of the Minister, or
(iii) any other person,
so provided in the manner (if any) specified in the document.

Minister’s power to extend time
34. Where—
(a) a provision of this Act specifies a period not later than which a person is required to provide any information to the Minister, and
(b) the Minister is satisfied, whether or not on the basis of a submission made to him or her by that person in that regard, that it is not reasonably practicable for the person to provide that information to the Minister within that period, the Minister may, by a notice in writing given to the person, extend that period by such further period as the Minister is satisfied is a period within which it is reasonably practicable for the person to provide that information to him or her.

Amendment of Dentists Act 1985
35. The Dentists Act 1985 (amended by section 33 of the Act of 2013) is amended—
(a) in section 38(1), by substituting “Subject to subsection (10), the Council or any person,” for “The Council or any person”,
(b) in section 38(1), by substituting the following for paragraph (c):
“(c) his alleged failure to comply with—
(i) regulations made under section 13 (2) of the Health (Pricing and Supply of Medical Goods) Act 2013 , or
(ii) a provision of the Health Identifiers Act 2014 applicable to the dentist in his capacity (if any) as a health services provider within the meaning of section 2 of that Act,”,
(c) in section 38(3) (b), by substituting the following for subparagraph (iii):
“(iii) the alleged failure to comply with regulations referred to in subsection (1) (c) (i) or a provision referred to in subsection (1) (c) (ii),”,
(d) in section 38(3) (c), by substituting the following for subparagraph (iii):
“(iii) the alleged failure to comply with regulations referred to in subsection (1) (c) (i) or a provision referred to in subsection (1) (c) (ii),”,
(e) in section 38(5), by substituting the following for paragraph (c):
“(c) guilty of a failure to comply with regulations referred to in subsection (1) (c) (i) or a provision referred to in subsection (1) (c) (ii),”,
(f) in section 38, by inserting the following after subsection (9):
(10) An application under this section shall not be made by a person other than the Minister if the ground concerned is a registered dentist’s alleged failure to comply with a provision referred to in subsection (1) (c) (ii).”,
and
(g) in section 39(1) (a), by substituting the following for subparagraph (iii):
“(iii) to be guilty of a failure to comply with regulations referred to in subsection (1) (c) (i) or a provision referred to in subsection (1) (c) (ii),”.

Amendment of section 52 of Health and Social Care Professionals Act 2005
36. Section 52 of the Health and Social Care Professionals Act 2005 is amended—
(a) in subsection (1), by substituting the following for paragraph (f):
“(f) a contravention of this Act, the rules or bye-laws,
(fa) a failure to comply with a provision of the Health Identifiers Act 2014 applicable to the registrant in his or her capacity (if any) as a health services provider within the meaning of section 2 of that Act, or”,
(b) in subsection (3), by substituting “Subject to subsection (3A), the complaint” for “The complaint”, and
(c) by inserting the following after subsection (3):
“(3A) A complaint shall not be made by a person other than the Minister if the ground concerned is a registrant’s failure to comply with a provision referred to in subsection (1) (fa).”.

Amendment of section 35 of Pharmacy Act 2007
37. Section 35 (amended by section 32 of the Act of 2013) of the Pharmacy Act 2007 is amended—
(a) in subsection (1), by substituting the following for paragraph (ea):
“(ea) a failure to comply with—
(i) Chapter 2 or 3 of Part 2, or Part 3, of the Health (Pricing and Supply of Medical Goods) Act 2013 , or
(ii) a provision of the Health Identifiers Act 2014 applicable to a pharmacist in his or her capacity (if any) as a health services provider within the meaning of section 2 of that Act,”,
(b) in subsection (3), by substituting “Subject to subsection (3A), a complaint” for “A complaint”, and
(c) by inserting the following after subsection (3):
“(3A) A complaint shall not be made by a person other than the Minister if the ground concerned is a registered pharmacist’s failure to comply with a provision referred to in subsection (1) (ea) (ii).”.

Amendment of section 57 of Medical Practitioners Act 2007
38. Section 57 (amended by section 34 of the Act of 2013) of the Medical Practitioners Act 2007 is amended—
(a) in subsection (1) —
(i) by substituting “Subject to subsection (1A), a person” for “A person”, and
(ii) by substituting the following for paragraph (fa):
“(fa) a failure to comply with—
(i) regulations made under section 13 (2) of the Health (Pricing and Supply of Medical Goods) Act 2013 , or
(ii) a provision of the Health Identifiers Act 2014 applicable to the practitioner in his or her capacity (if any) as a health services provider within the meaning of section 2 of that Act.”,
and
(b) by inserting the following after subsection (1):
“(1A) A complaint shall not be made by a person other than the Minister if the ground concerned is a registered medical practitioner’s failure to comply with a provision referred to in subsection (1) (fa) (ii).”.

Amendment of section 55 of Nurses and Midwives Act 2011
39. Section 55 (amended by section 35 of the Act of 2013) of the Nurses and Midwives Act 2011 is amended—
(a) in subsection (1) —
(i) by substituting “Subject to subsection (1A), a person” for “A person”, and
(ii) by substituting the following for paragraph (ga):
“(ga) a failure to comply with—
(i) regulations made under section 13(2) of the Health (Pricing and Supply of Medical Goods) Act 2013 , or
(ii) a provision of the Health Identifiers Act 2014 applicable to the nurse or midwife in his or her capacity (if any) as a health services provider within the meaning of section 2 of that Act,”,
(b) by inserting the following after subsection (1):
“(1A) A complaint shall not be made by a person other than the Minister if the ground concerned is a registered nurse’s or registered midwife’s failure to comply with a provision referred to in subsection (1)(ga)(ii).”.
SCHEDULE 1

Authorised Disclosees (Persons Who May Process Relevant Information (Individuals) for Particular Secondary Purposes)
Section 2
Item No.
1. Bord na Radharcmhastóirí.
2. Central Statistics Office.
3. A coroner.
4. Dental Council.
5. Health Information and Quality Authority.
6. Health Insurance Authority.
7. Inspector of Mental Health Services.
8. Medical Council.
9. National Treatment Purchase Fund Board.
10. Nursing and Midwifery Board of Ireland.
11. Pharmaceutical Society of Ireland.
12. Pre-Hospital Emergency Care Council.
13. A registration board established by or under the Health and Social Care Professionals Act 2005 .
(14) An undertaking authorised to operate a scheme of health or health-related insurance under the Health Insurance Act 1994 .
SCHEDULE 2

Persons Who Fall within Paragraph (b) of Definition of “Specified Person” in Section 2 (1)
Section 2
Item No. Specified Person
(1) Chief Inspector of Social Services.
(2) Child and Family Agency.
(3) Health Research Board.
(4) Irish Blood Transfusion Service.
(5) Irish Medicines Board.
(6) Mental Health Commission.
(7) National Cancer Registry Board.
(8) State Claims Agency.
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