The National Health Service (Personal Medical Services Agreements) Regulations 2015

PART 11E+WRecords and information

Patient recordsE+W

60.—(1) The contractor must keep adequate records of its attendance on and treatment of patients.

(2) A contractor which provides essential services must keep the records referred to in paragraph (1)—

(a)on forms supplied to it for the purpose by [F1NHS England]; or

(b)with the written consent of [F1NHS England], by way of computerised records,

or in a combination of those two ways.

(3) A contractor which provides essential services must include in the records referred to in paragraph (1), clinical reports sent in accordance with paragraph 7 of Schedule 2 or from any other health care professional who has provided clinical services to a person on the contractor's list of patients.

(4) The consent of [F1NHS England] required by paragraph (2)(b) may not be withheld or withdrawn provided [F1NHS England] is satisfied, and continues to be satisfied, that—

[F2(a)the computer system upon which the contractor proposes to keep the records meets the requirements set out in the GPIT Operating Model;]

(b)the security measures, audit and system management functions incorporated into the computer system [F3and compliant with the GPIT Operating Model] have been enabled; and

(c)the contractor is aware of, and has signed an undertaking that it will have regard to, the guidelines contained in “The Good Practice Guidelines for GP electronic patient records (Version 4)” published on 21st March 2011 M1.

(5) Where the patient's records are computerised records, the contractor must, as soon as possible following a request from [F1NHS England], allow [F1NHS England] to access the information recorded on the computer system on which those records are held by means of the audit function referred to in paragraph (4)(b) to the extent necessary for [F1NHS England] to confirm that the audit function is enabled and functioning correctly.

F4[F5(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6A) Where a patient on a contractor’s list of patients has registered with another provider of primary medical services and the contractor receives a request from that provider for the complete records relating to that patient, the contractor must send to [F1NHS England]—

(a)the complete records, or any part of the records, sent via the GP2GP facility in accordance with regulation 62 for which the contractor does not receive confirmation of safe and effective transfer via that facility; and

(b)any part of the records held by the contractor only in paper form.

(6B) Where a patient on a contractor’s list of patients—

(a)is removed from that list at that patient’s request under paragraph 22 of Schedule 2, or by reason of the application of any of paragraphs 23 to 30 of that Schedule; and

(b)the contractor has not received a request from another provider of medical services with which that patient has registered for the transfer of the complete records relating to that patient,

the contractor must send a copy of those records to [F1NHS England].

(6C) Where a contractor’s responsibility for a patient terminates in accordance with paragraph 31 of Schedule 2, the contractor must send any records relating to that patient that it holds to—

(a)if known, the provider of primary medical services with which that patient is registered; or

(b)in all other cases, [F1NHS England].

(6D) For the purposes of this regulation, “GP2GP facility” has the same meaning as in paragraph (2) of regulation 62.]

F6(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(9) A contractor whose patient records are computerised records must not disable, or attempt to disable, either the security measures or the audit system management functions referred to in paragraph (4)(b).

(10) In this regulation, “computerised records” means records created by way of entries on a computer.

[F8Record of ethnicity informationE+W

60A.—(1) This regulation applies if a contractor, or a person acting on behalf of a contractor, makes a request to a patient (“P”) for P to disclose their ethnicity to the contractor so that information can be recorded in P’s medical record (a “relevant request”).

(2) If P, or where P is a person to whom paragraph (4) applies, an appropriate person [F9acting on behalf of P], discloses P’s ethnicity in response to the relevant request, the contractor must record P’s ethnicity in P’s medical record.

(3) If P, or where P is a person to whom paragraph (4) applies, an appropriate person [F10acting on behalf of P], indicates that they would prefer not to disclose P’s ethnicity in response to the relevant request, the contractor must record that response in P’s medical record.

(4) This paragraph applies to a person if they—

(a)are a child, or

(b)lack the capacity to respond to the relevant request.

(5) Any information recorded in accordance with this regulation may only be processed if the processing is necessary for medical purposes.

(6) Nothing in this regulation authorises the processing of personal data in a manner inconsistent with any provision of the data protection legislation.

(7) In this regulation—

F11...

“data protection legislation”, “personal data” and “processing” have the same meanings as in the Data Protection Act 2018 (see section 3 of that Act);

“medical purposes” has the meaning given for the purposes of section 251 of the Act.]

Summary Care RecordE+W

61.—(1) A contractor which provides essential services must, in any case where there is a change to the information included in a patient's medical record, enable the automated upload of summary information to the Summary Care Record, [F12when the change occurs], using approved systems provided to it by [F1NHS England].

(2) In this regulation—

“Summary Care Record” means the system approved by [F1NHS England] for the automated uploading, storing and displaying of patient data relating to medications, allergies, adverse reactions and, where agreed with the contractor and subject to the patient's consent, any other data [F13(other than any information recorded in accordance with regulation 60A)] [F14or any information about ethnicity provided under regulation 64C] taken from the patient's electronic record; and

“summary information” means items of patient data that comprise the Summary Care Record.

Electronic transfer of patient records between GP practicesE+W

62.—(1) A contractor which provides essential services must use the facility known as “GP2GP” for the safe and effective transfer of any patient records—

(a)in a case where a new patient registers with the contractor's practice, to the contractor's practice from another provider of primary medical services (if any) with which the patient was previously registered; or

(b)in a case where the contractor receives a request from another provider of primary medical services with which the patient has registered, in order to respond to that request.

(2) In this regulation, “GP2GP facility” means the facility provided by [F1NHS England] to a contractor's practice which enables the electronic health records of a registered patient which are held on the computerised clinical systems of the contractor's practice to be transferred securely and directly to another provider of primary medical services with which the patient has registered.

(3) The requirements of this regulation do not apply in the case of a temporary resident.

[F15Transfer of patient records between GP practices: time limitsE+W

62A.—(1) This regulation applies where—

(a)a patient on a contractor’s list of patients has registered with another provider of primary medical services, and

(b)the contractor receives a request from that provider for the complete records relating to that patient.

(2) The contractor must, before the end of the period of 28 days beginning with the day on which it receives the request from the provider—

(a)send the complete records (other than any part of the records held only in paper form) to the provider via the GP2GP facility in accordance with regulation 62, and

(b)send to [F1NHS England] in accordance with regulation 60(6A), the complete records, or any part of the records—

(i)for which the contractor does not receive a confirmation, or

(ii)held only in paper form.

(3) In this regulation—

“confirmation”, in relation to records sent via the GP2GP facility, means confirmation of safe and effective transfer via that facility;

“GP2P facility” has the same meaning as in paragraph (2) of regulation 62.]

Clinical correspondence: requirement for NHS numberE+W

63.—(1) A contractor must include the NHS number of a registered patient as the primary identifier in all clinical correspondence issued by the contractor which relates to that patient.

(2) The requirement in paragraph (1) does not apply where, in exceptional circumstances outside of the contractor's control, it is not possible for the contractor to ascertain the patient's NHS number.

(3) In this regulation—

“clinical correspondence” means all correspondence in writing, whether in electronic form or otherwise, between the contractor and other health service providers concerning or arising out of [F16the provision of a remote service or] patient attendance and treatment at practice premises including referrals made by letter or by any other means; and

“NHS number”, in relation to a registered patient, means the number, consisting of ten numeric digits, which serves as the national unique identifier used for the purpose of safely, efficiently and accurately sharing information relating to that patient across the whole of the health service in England.

[F17Use of fax machinesE+W

63A.—(1) Where a contractor can transmit information by electronic means (other than facsimile transmission) securely and directly to a relevant person, the contractor must not—

(a)transmit any information to that person by facsimile transmission, or

(b)agree to receive any information from that person by facsimile transmission.

(2) Paragraph (1) does not apply to any information which relates solely to the provision of clinical services or treatment to a patient under a private arrangement.

(3) In this regulation, “relevant person” means—

(a)an NHS body,

(b)another health service provider,

(c)a patient, or

(d)a person acting on behalf of a patient.]

Patient online services [F18: appointments and prescriptions] E+W

64.—(1) A contractor which provides essential services must promote and offer to its registered patients the facility for a patient to—

(a)book, view, amend, cancel and print appointments online;

(b)order repeat prescriptions for drugs, medicines or appliances online; and

(c)view and print a list of any drugs, medicines or appliances in respect of which the patient has a repeat prescription,

in a manner which is capable of being electronically integrated with the computerised clinical systems of the contractor's practice using appropriate systems authorised by [F1NHS England].

(2) The requirements in paragraph (1) do not apply where the contractor does not have access to computer systems and software which would enable it to offer the online services described in that paragraph to its registered patients.

[F19(3) A contractor must when complying with the requirements in paragraph (1)(a)—

(a)ensure that [F20all of its directly bookable appointments] are made available for online booking, whether or not those appointments are booked online, by telephone or in person, to include all appointments which must be made available for direct booking by NHS 111 in accordance with paragraph 16B of Part 2 of Schedule 2 to these Regulations; and

(b)consider whether it is necessary, in order to meet the needs of its registered patients, to increase the proportion of appointments which are available for its registered patients to book online and, if so, increase that number.

(3A) In the case of appointments required to be made available for direct booking by NHS 111, in accordance with paragraph 16B of Part 2 of Schedule 2 to these Regulations, those appointments can be released to be booked by a contractor’s registered patients by any means in the two hour period within core hours prior to the appointment time, or such other period agreed pursuant to a local arrangement, if they have not been booked by NHS 111 prior to this time.]

F21(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F22(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F23(5A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F24(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F25(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) F26... The contractor must also promote and offer to its registered patients the facility referred to in paragraph (1)(a) and (b) on [F27the home page (or equivalent) of] [F28its practice website or online practice profile].

[F29(9) In this regulation—

(a)“local arrangement” means an arrangement between the contractor and [F1NHS England] as to the timeframe within which appointments not booked by NHS 111 can be released for booking by the contractor’s registered patients; and

F30(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

[F31[F32Patient online services: provision of online access to coded information in medical record and prospective medical recordsE+W

64ZA.—(1) Where the contractor holds the medical record of a registered patient (“P”) on its computerised clinical systems, the contractor must—

(a)provide P with the facility to access online information entered onto P’s medical record on or after the relevant date (the “prospective medical record”); and

(b)promote and offer to P, in accordance with paragraph (2), the facility to access online the information from P’s medical record held in coded form.

(2) For the purposes of paragraph (1)(b), the contractor is taken to be—

(a)promoting the facility to P where P is encouraged to utilise the practice’s digital services and to interact with the practice via online access;

(b)offering the facility to P where it is freely available to P if P shows interest in the facility or requests access in writing to their medical records held in coded form.

(3) Where a person (“R”) applies to become a registered patient of the contractor, the contractor must, as part of the registration process—

(a)make information available to R about the practice’s digital services and about how R may interact with the practice via online access; and

(b)inform R in writing that on becoming a registered patient, R will be provided with the facility to access R’s prospective medical record (unless R chooses not to be provided with that facility).

(4) The contractor must configure its computerised clinical systems so as to allow its registered patients the facility to access online information entered onto their medical record.

(5) In this regulation, “relevant date” means—

(a)if the contractor has not provided P with the facility to access online P’s prospective medical record under this regulation as in force immediately before 15th May 2023, the day on which the contractor does provide the facility under paragraph (1)(a); or

(b)31st October 2023,

whichever is the earlier.

(6) Where—

(a)the contractor has not, before 15th May 2023, provided P with the facility to access online P’s prospective medical record; and

(b)P makes a request in writing to the contractor on or after 15th May 2023 but before 31st October 2023, to be provided with that facility,

the contractor must provide that facility to P by the end of the compliance period or by 31st October 2023 whichever is the earlier.

(7) Where—

(a)the contractor has not, before 1st November 2023, for whatever reason, provided P with the facility to access online P’s prospective medical record; and

(b)P makes a request in writing to the contractor on or after 31st October 2023 to be provided with that facility,

the contractor must provide P with that facility by the end of the compliance period.

(8) Subject to paragraph (9), the contractor must not remove the facility of a registered patient to access online their medical record provided under—

(a)this regulation as in force immediately before 15th May 2023; or

(b)paragraph (1).

(9) Nothing in this regulation requires the contractor to provide P with the facility to access—

(a)online information entered onto the medical record where that information is excepted information;

(b)online information entered onto P’s prospective medical record where P has informed the contractor that they do not, or no longer, wish to be provided with that facility; or

(c)information referred to in paragraph (1)(b) which the contractor’s computerised systems cannot separate from any free-text entry in P’s medical record.

(10) For the purposes of this regulation and regulation 64ZB—

(a)“the compliance period” means the period specified in Article 12 of the UK GDPR for compliance with a request made in exercise of a right under Article 15 of the UK GDPR;

(b)information is “excepted information” if the contractor would not be required to disclose it in response to a request made in exercise of a right under Article 15 of the UK GDPR.

(11) For the purposes of paragraph (10), “UK GDPR” has the meaning given in section 3(10) of the Data Protection Act 2018.]

Patient online services: provision of online access to full digital medical recordE+W

64ZB.—(1) A contractor must provide a registered patient (“P”) with the facility to access online relevant medical information if—

(a)its computerised clinical systems F33... allow it to do so, and

(b)P requests, in writing, that it provide that facility.

[F34(1A) Where P makes a request under paragraph (1)(b), the contractor must provide P with the facility by the end of the compliance period.

(1B) The contractor must configure its computerised clinical systems so as to allow its registered patients the facility to access online their relevant medical information.]

(2) In this regulation “relevant medical information” means any information entered on P’s medical record other than—

(a)any information which P can access online via a facility [F35provided in accordance with regulation 64ZA(1)], or

(b)any excepted information.]

[F36Patient online services: providing and updating personal or contact informationE+W

64ZC.—(1) A contractor must offer and promote to its registered patients a facility for providing their personal or contact information, or informing the contractor of a change to that information, which meets the condition in paragraph (2).

(2) A facility meets the condition in this paragraph if it enables—

(a)P, or

(b)where P is a person to whom paragraph (3) applies, an appropriate person acting on behalf of P,

to provide the contractor with, or inform it of any change to, P’s personal or contact information in P’s medical record, either online or by other electronic means.

(3) This paragraph applies to a person if they—

(a)are a child, or

(b)lack the capacity to provide the contractor with their personal or contact information or to authorise a person to provide such information on their behalf.

(4) For the purposes of this regulation, P’s personal and contact information is—

(a)their name;

(b)their ethnicity;

(c)their address;

(d)their telephone number or mobile telephone number (if any);

(e)their electronic mail address (if any).

Patient online services: provision of an online consultation toolE+W

64ZD.—(1) A contractor must offer and promote an online consultation tool to its registered patients.

(2) An “online consultation tool” is an online facility provided using appropriate software—

(a)through which—

(i)a patient, or

(ii)where the patient is a person to whom paragraph (4) applies, an appropriate person acting on behalf of the patient,

may, in writing in electronic form, seek advice or information related to the patient’s health or make a clinical or administrative request, but

(b)which does not require the response to be given by the contractor in real time.

(3) An online consultation tool may incorporate—

(a)any of the facilities which the contractor is required to offer [F37, promote or, as the case may be, provide] under regulations 64 to 64ZC, or

(b)the communication method which the contractor is required to offer [F38and promote] under regulation 64ZE.

(4) This paragraph applies to a person if they—

(a)are a child, or

(b)lack the capacity to communicate with the contractor through an online facility or to authorise a person to communicate with the contractor through such a facility on their behalf.

Secure electronic communicationsE+W

64ZE.—(1) A contractor must—

(a)offer and promote to its registered patients a relevant electronic communication method, and

(b)use the relevant electronic communication method to communicate with—

(i)a registered patient, or

(ii)where the registered patient is a person to whom paragraph (4) applies, an appropriate person acting on behalf of the patient.

(2) But paragraph (1)(b) does not require the contractor to use the relevant electronic communication method where—

(a)it would not be clinically appropriate to do so for the patient on that occasion, or

(b)it is otherwise not appropriate to the needs or circumstances of the patient.

(3) For the purposes of this regulation, a “relevant electronic communication method” is a method of electronic communication which is provided using appropriate software and which can be used—

(a)by the contractor to respond, in writing in electronic form, to requests made through the online consultation tool, and

(b)by the contractor and its registered patients or appropriate persons acting on behalf of registered patients (as the case may be) to otherwise communicate with each other, in writing in electronic form.

(4) This paragraph applies to a person if they—

(a)are a child, or

(b)lack the capacity to communicate with the contractor using the relevant electronic communication method or to authorise a person to do so on their behalf.

Video consultationsE+W

64ZF.—(1) A contractor must offer and promote to its registered patients the facility of participating in their consultations with the contractor by video conference provided using appropriate software (“video consultations”).

(2) But paragraph (1) does not require the contractor to offer a patient a video consultation where—

(a)it would not be clinically appropriate to do so for the patient on that occasion, or

(b)it is otherwise not appropriate to the needs or circumstances of the patient.

(3) The contractor must not be party to a contract or other arrangement under which the software mentioned in paragraph (1) is provided unless—

(a)it is satisfied that any software which a patient needs to participate in a video consultation with the contractor’s practice is available free of charge to the patient, and

(b)it has taken reasonable steps, having regard to the arrangement as a whole and disregarding the costs of any software, to satisfy itself that patients will not have to pay more to participate in video consultations with the contractor’s practice than they would to participate in a meeting by video conference with any other person in the contractor’s area.

Meaning of “appropriate software” for the purposes of regulations 64ZD, 64ZE and 64ZFE+W

64ZG.—(1) For the purposes of regulations 64ZD, 64ZE and 64ZF software which is used to provide a method of communication or facility (as the case may be) is appropriate if the software meets—

(a)the requirements in the GPIT Operating Model relevant to that software, or

(b)requirements which are equivalent in their effect to the relevant requirements in the GPIT Operating Model.

F39(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

[F40Patient access to online servicesE+W

64A.—(1) This regulation applies to any contractor which has less than ten per cent of its registered patients registered with the contractor’s practice to use the online services which the contractor is required under regulation 64 [F41or regulation 64ZA(1) or (2)] to [F42promote, offer or, as the case may be, provide] to its registered patients (“patient online services”).

(2) A contractor to which this regulation applies must agree a plan with [F1NHS England] aimed at increasing the percentage of the contractor’s registered patients who are registered with the contractor’s practice to use patient online services.]

[F43Patient access: other availability of directly bookable appointmentsE+W

64B.  A contractor must ensure that all of its directly bookable appointments are made available for booking by telephone or in person.]

Confidentiality of personal data: nominated personE+W

65.  The contractor must nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it.

[F44Requirement to have and maintain an online presenceE+W

66.—(1) A contractor must have—

(a)a practice website, or

(b)an online practice profile.

(2) The contractor must publish on its practice website or profile (as the case may be) all the information which is required to be included in its practice leaflet.

(3) The contractor must publish that information otherwise than by making its practice leaflet available for viewing or downloading.

(4) The contractor must review the information available on its practice website or profile at least once in every period of 12 months.

(5) The contractor must make any amendments necessary to maintain the accuracy of the information on its website or profile following—

(a)a review under paragraph (4);

(b)a change to—

(i)the address of any of the contractor’s practice premises,

(ii)the contractor’s telephone number,

(iii)the contractor’s electronic-mail address (if made available on its website or profile), or

(iv)any other stated means by which a patient may contact the contractor to book or amend an appointment, or to order repeat prescriptions for drugs, medicines or appliances.

[F45(5A) The contractor must also ensure there are links on its website or profile which direct people to—

(a)its online consultation tool, and

(b)the symptom checker and self-care information available on the NHS website.

(5B) The links mentioned in paragraph (5A) must be displayed prominently on the home page (or equivalent) of its website or profile (as the case may be).]

(6) The requirements in this regulation are in addition to those in regulation 21 and paragraph 15(8) of Schedule 2.

(7) In these Regulations, “online practice profile” means a profile—

(a)which is on a website (other than the NHS website), or an online platform, provided by another person for use by a contractor, and

(b)through which the contractor advertises the primary medical services it provides.

Requirement to maintain profile page on NHS websiteE+W

66A.—(1) A contractor must review the information available on its profile page on the NHS website at least once in every period of 12 months.

(2) The contractor must make any amendments necessary to maintain the accuracy of the information its profile page following—

(a)a review under paragraph (1);

(b)a change to—

(i)the address of any of the contractor’s practice premises,

(ii)the contractor’s telephone number,

(iii)the contractor’s electronic-mail address (if made available on its profile page), or

(iv)any other stated means by which a patient may contact the contractor to book or amend an appointment, or to order repeat prescriptions for drugs, medicines or appliances.]

Provision of informationE+W

67.—(1) Subject to paragraph (2), the contractor must, at the request of [F1NHS England], produce to [F1NHS England], or to a person authorised in writing by [F1NHS England], or allow [F1NHS England], or a person authorised in writing by [F1NHS England], to access—

(a)any information which is reasonably required by [F1NHS England] for the purposes of or in connection with the agreement; and

(b)any other information which is reasonably required in connection with [F1NHS England’s] functions.

(2) The contractor is not be required to comply with any request made under paragraph (1) unless it has been made by [F1NHS England] in accordance with directions relating to the provision of information by contractors given to it by the Secretary of State under section 98A of the Act (exercise of functions).

(3) The contractor must produce the information requested, or, as the case may be, allow [F1NHS England], or a person authorised by [F1NHS England], access to such information—

(a)by such date as has been agreed as reasonable between the contractor and [F1NHS England]; or

(b)in the absence of such agreement, before the end of the period of 28 days beginning with the date on which the request is made.

Provision of information: GP access dataE+W

F4667A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F47National Diabetes AuditE+W

67B.—(1) A contractor must record any data required by [F1NHS England] for the purposes of the National Diabetes Audit in accordance with paragraph (2).

(2) The data recorded under paragraph (1) must be appropriately coded by the contractor and uploaded onto the contractor’s computerised clinical systems in accordance with the requirements of guidance published by NHS Employers for these purposes.

(3) The contractor must ensure that the coded data is uploaded onto its computerised clinical systems and available for collection by [F48NHS England] at such intervals during each financial year as are notified to the contractor by [F48NHS England].

Information relating to indicators no longer in the Quality and Outcomes FrameworkE+W

67C.  A contractor must allow the extraction from the contractor’s computerised clinical systems by [F49NHS England] of the information specified in the Table relating to clinical indicators which are no longer in the Quality and Outcomes Framework at such intervals during each financial year as are notified to the contractor by [F49NHS England].

Information relating to alcohol related risk reduction and dementia diagnosis and treatmentE+W

67D.—(1) A contractor must allow the extraction by [F54NHS England] of the information specified in—

(a)paragraph (2) in relation to alcohol related risk reduction; and

(b)paragraph (3) in relation to dementia diagnosis and treatment,

from the record that the contractor is required to keep in respect of each registered patient under regulation 60 by such means, and at such intervals during each financial year, as are notified to the contractor by [F54NHS England].

(2) The information specified in this paragraph is information required in connection with the requirements under paragraph 14 of Schedule 2.

(3) The information specified in this paragraph is information relating to any clinical interventions provided by the contractor in the preceding 12 months in respect of a patient who is suffering from, or who is at risk of suffering from, dementia.

[F55[F56NHS England] Workforce Collection]E

67E.—(1) A contractor must record and submit any data required by [F57NHS England] for the purposes of the [F58NHS Workforce Collection] (known as the “Workforce Minimum Data Set”) in accordance with paragraph (2).

[F59(2) The data referred to in paragraph (1) must be appropriately coded by the contractor in line with agreed standards set out in guidance published by [F57NHS England], and must be submitted to [F57NHS England] using the data entry module on the National Workforce Reporting System, which is a facility provided by [F57NHS England] to the contractor for this purpose.]

(3) The contractor must ensure that the coded data is available for collection by [F57NHS England] at such intervals during each financial year as are notified to the contractor by [F57NHS England].

Information relating to overseas visitorsE+W

67F.—(1) A contractor must—

(a)record the information specified in paragraph (2) relating to overseas visitors, where that information has been provided to it by a newly registered patient on a form supplied to the contractor by [F1NHS England] for this purpose; and

[F60(b)where applicable in the case of a patient, record the fact that the patient is the holder of a document—

(i)which is—

(aa)a European Health Insurance Card;

(bb)an S1 Healthcare Certificate; or

(cc)a document which, for the purposes of a listed healthcare arrangement as defined in regulation 1(3) of the Healthcare (European Economic Area and Switzerland Arrangements) (EU Exit) Regulations 2019, is treated as equivalent to a document referred to in sub-paragraph (aa) (“EHIC equivalent document”) or (bb) (“S1 equivalent document”); and

(ii)which has not been issued to or in respect of the patient by the United Kingdom,]

in the medical record that the contractor is required to keep under regulation 60 in respect of the patient.

(2) The information specified in this paragraph is—

(a)in the case of a patient who holds a European Health Insurance Card [F61or EHIC equivalent document] which has not been issued to the patient by the United Kingdom, the information contained on that card [F62or document] in respect of the patient; and

(b)in the case of a patient who holds a Provisional Replacement Certificate issued in respect of the patient’s European Health Insurance Card, the information contained on that certificate in respect of the patient.

(3) The information referred to in paragraph (2) must be submitted by the contractor to [F63NHS England]—

[F64(a)electronically at nhsdigital.costrecovery@nhs.net;]

(b)by post in hard copy form to EHIC, PDS NBO, NHS Digital, Smedley Hydro, Trafalgar Road, Southport, Merseyside, PR8 2HH.

(4) Where the patient is the holder of an S1 Healthcare Certificate [F65or S1 equivalent document], the contractor must send that certificate [F66or document], or a copy of that certificate [F66or document], to the [F67the NHS Business Services Authority]—

[F68(a)electronically to nhsbsa.faregistrationsohs@nhs.net, or]

[F68(b)by post in hard copy form to Cost Recovery, Overseas Healthcare Service, Bridge House, 152 Pilgrim Street, Newcastle Upon Tyne, NE1 6SN.]]

[F69Medicines and Healthcare products Regulatory Agency Central Alerting SystemE+W

67G.  A contractor must—

(a)provide to the Medicines and Healthcare products Regulatory Agency (“the MHRA”) on request, an electronic mail address which is registered to the contractor’s practice;

(b)monitor that address;

(c)if that address ceases to be registered to the practice, notify the MHRA immediately of its new electronic mail address; and

(d)provide to the MHRA on request, one or more mobile telephone numbers for use in the event the contractor is unable to receive electronic mail.]

[F70Collection of data relating to appointments in general practiceE

67H.—(1) A contractor must participate in the collection of anonymised data relating to appointments for its registered patients (“GP practice data”) in accordance with the “GP Appointments Data Collection in Support of Winter Pressures” referred to in the Health and Social Care Information Centre (Establishment of Information Systems for NHS Services: General Practice Appointments Data Collection in Support of Winter Pressures) Directions 2017 [F71(the functions of the Health and Social Care Information Centre under the Directions were transferred to NHS England by the Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023)].

(2) The contractor must ensure that all GP practice data relating to the provision of primary medical services under its contract is recorded within the appointment book in accordance with the guidance.

(3) The contractor must ensure that the GP practice data is uploaded onto its computerised clinical systems and available for collection by [F72NHS England] at such intervals during each financial year as notified to the contractor by [F72NHS England].

(4) For the purposes of this regulation, “appointment book” means a capability provided by the contractor’s computerised clinical systems and software supplier which supports the administration, scheduling, resourcing and reporting of appointments.]

[F73Collection of data concerning use of online consultation tools and video consultationsE+W

67I.  A contractor must submit to [F1NHS England] such anonymised data relating to the use of its online consultation tool and video consultation facility as [F1NHS England] may require.]

Inquiries about prescriptions and referralsE+W

68.—(1) The contractor must, subject to paragraphs (2) and (3), sufficiently answer any inquiries, whether oral or in writing, from [F1NHS England] concerning—

(a)any prescription form or repeatable prescription form issued or created by a prescriber;

(b)the considerations by reference to which prescribers issue such forms;

(c)the referral by or on behalf of the contractor of any patient to any other services provided under the Act; or

(d)the considerations by which the contractor makes such referrals or provides for them to be made on its behalf.

(2) An inquiry referred to in paragraph (1) may only be made for the purpose of obtaining information to assist [F1NHS England] to discharge its functions, or of assisting the contractor in the discharge of its obligations, under the agreement.

(3) The contractor is not obliged to answer any inquiry referred to in paragraph (1) unless it is made—

(a)in the case of paragraph (1)(a) or (b), by an appropriately qualified health care professional; or

(b)in the case of paragraph (1)(c) or (d), by an appropriately qualified medical practitioner.

(4) The appropriately qualified person referred to in paragraph (3)(a) or (b) must —

(a)be appointed by [F1NHS England] to assist it in the exercise of [F1NHS England’s] functions under this regulation; and

(b)produce on request, written evidence that they are authorised by [F1NHS England] to make such an inquiry on [F1NHS England’s] behalf.

Provision of information to a medical officer etc.E+W

69.—(1) The contractor must, if satisfied that the patient consents—

(a)supply in writing to any person specified in paragraph (3), (a “relevant person”), before the end of such reasonable period as that person may specify, such clinical information as any of the persons mentioned in paragraph (3)(a) to (d) considers relevant about a patient to whom the contractor, or a person acting on behalf of the contractor, has issued or has refused to issue a medical certificate; and

(b)answer any inquiries by a relevant person about—

(i)a prescription form or medical certificate issued or created by, or on behalf of, the contractor; or

(ii)any statement which the contractor, or a person acting on behalf of the contractor, has made in a report.

(2) For the purposes of being satisfied that a patient consents, a contractor may rely on an assurance in writing from a relevant person that the consent of the patient has been obtained, unless the contractor has reason to believe that the patient does not consent.

(3) For the purposes of this regulation, a “relevant person” is—

(a)a medical officer;

(b)a nursing officer;

(c)an occupational therapist;

(d)a physiotherapist; or

(e)an officer of the Department for Work and Pensions who is acting on behalf of, and at the direction of, any person specified in sub-paragraphs (a) to (d).

(4) In this regulation—

“medical officer” means a medical practitioner who is—

“nursing officer” means a health care professional who is registered on the Nursing and Midwifery Register and who is—

“occupational therapist” means a health care professional who is registered in the part of the register maintained by the Health Professions Council under article 5 of the [F74Health Professions Order 2001]M2 (establishment and maintenance of register) relating to occupational therapists and who is—

“physiotherapist” means a health care professional who is registered in the part of the register maintained by the Health Professions Council under article 5 of the [F75Health Professions Order 2001] (establishment and maintenance of register) relating to physiotherapists and who is—

Annual return and reviewE+W

70.—(1) The contractor must submit to [F1NHS England] an annual return relating to the agreement which must require the same categories of information to be provided by all persons who hold agreements with [F1NHS England].

(2) [F1NHS England] may request a return relating to the agreement at any time during each financial year in relation to such period (not including any period covered by a previous annual return) as may be specified in the request.

(3) The contractor must submit the completed return to [F1NHS England]—

(a)by such date as has been agreed as reasonable between the contractor and [F1NHS England]; or

(b)in the absence of such agreement, before the end of the period of 28 days beginning with the date on which the request was made.

(4) Following receipt of the return referred to in paragraph (1), [F1NHS England] must arrange with the contractor an annual review of its performance in relation to the agreement.

(5) [F1NHS England] must prepare a draft record of the review referred to in paragraph (2) for comment by the contractor and, having regard to such comments, must produce a final written record of the review.

(6) [F1NHS England] must send a copy of the final record of the review referred to in paragraph (5) to the contractor.

Practice leafletE+W

71.—(1) A contractor which provides essential services must compile a document (a “practice leaflet”) which must include the information specified in Part 6 of Schedule 2.

(2) The contractor must review its practice leaflet at least once in every period of 12 months and make any amendments necessary to maintain its accuracy.

(3) The contractor must make available a copy of the leaflet, and any subsequent updates, to its patients and prospective patients.