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Clinical safety and the NHS App

An overview of clinical risk management relevant to the NHS App.

The NHS App has been designed, built, tested and clinically reviewed with patient safety at its heart, in accordance with mandated safety standards DCB0129 and DCB0160. As part of this commitment to safety we need to be kept informed of any clinical incidents that may occur from use of the NHS App. This is so we can learn from them and prevent recurrence wherever possible. 

If a clinical incident occurs, in addition to following standard operating procedures at practice level, incidents should be logged with the NHS Digital National Service Desk.

Email: [email protected]

Tel: 0300 303 5035


NHS App Clinical Safety Case

The NHS App Clinical Safety Case (CSC) contains the following live documents:

  • Hazard Log
  • Clinical Safety Case Report (CSCR)

Existing risks are reviewed alongside new features being assessed and added. 

All integrations and developments for the NHS App are clinically reviewed by multi-disciplinary teams via hazard assessment workshops. Information about each feature and/ or supplier integration is updated and approved by the NHS App clinical safety team made up of a Clinical Safety Officer and Clinical Safety Engineer. 

The context and premise of the feature/integration is condensed and provided in the supplementary approval document known as the Clinical Authority to Release (CATR) following Clinical Safety Group (CSG) approval. As a live document the CATR is kept under review. 

The NHS App CATR on this page will be the most up to date version available for the product and is subject to regular review and update from the Clinical Safety Team.


Clinical Risk Management

Before any functions or features go live on the NHS App, NHS Digital undertakes a formal review of the clinical risk management activities. This is to ensure the requirements for the clinical safety management system have been addressed. This review is conducted by the Clinical Safety Group (CSG). 

This review is consistent with the scale of the overarching clinical risk management process. 

The review demonstrates that:

  • the NHS App clinical risk management plan has been implemented and the outcomes recorded
  • any remaining clinical risk for each hazard is acceptable
  • appropriate methods are in place to make sure relevant post-deployment information is captured in the NHS App clinical risk management system

The CSG also needs to be satisfied that any outstanding defects that remain unresolved at release have been reviewed by the operational Clinical Safety Officer (CSO) and that the potential impact on clinical safety has been assessed.

If the risk of any outstanding defects remains unacceptable, the NHS App must consider implementing additional risk control measures. Where further risk control measures are considered impractical a clinical risk benefits analysis will be carried out to establish whether the benefits of the release outweigh the remaining clinical risk.

Once satisfied with the review, a Clinical Authority to Release (CATR) is issued. 


Clinical Authority to Release (CATR) for the NHS App

(Issue 24.0) National Booking Service Integration with the NHS App

Issue 24.0 of this CATR captures the clinical risk management activities undertaken in support of the NBS Integration and onboarding to NHS App.

The NHS App Clinical Team has issued a Safety Case Report (CSCR) addendum, capturing the scope:

  • NHS App Users are able to book an appointment for COVID-19 vaccination via the NHS App
  • the NHS App User has an authenticated booking journey for COVID-19 via NHS App
  • a booking journey for NHS login P9 verified users
  • login authentication in front of NBS's web application
  • the user receiving their booking notifications via NHS App
  • the user receiving push notifications to book an appointment based on their eligibility

Date issued: 23 November 2022

(Issue 23.0) Secure Inbox within the NHS App

Issue 23.0 of this CATR captures the clinical risk management activities undertaken in support of the secure inbox within the NHS App. 

‘Secure inbox’ gives the ability for a patient to receive push notifications and messages on their personal device regarding the following:

  • appointments
  • correspondence
  • public health information

The ability for suppliers to send messages to individual patients, allowing them to reply is not in scope for Minimum Viable Product (MVP) but is in development for future releases. The Secure Inbox is another channel that can be used by GP practices to communicate with their patients instead of the traditional SMS. This might include messages that pertain to the services the practice offers to its patients. The service will only be available for P9 verified users.

Date issued: 21 September 2022

(Issue 22.0) Uplift to the CSCR related to the Wayfinder Service

Issue 22.0 of this CATR reflects a minor uplift to the CSCR related to the Wayfinder Service CATR version 21.0.

Date issued: 16 September 2022

(Issue 21.0) Wayfinder Service

Issue 21.0 of this CATR captures the clinical risk management activities undertaken in support of the new Wayfinder service, specifically the additional capability within the NHS App. 

The overarching Wayfinder solution is developed to support a patient engagement portal within the NHS App to identify national interventions that would support patients waiting for treatment, and to mitigate the impact for longer waits on patients and the NHS itself. 

To support this goal, a third-party supplier (Servita) was commissioned to build an aggregator layer to collate the patient data (appointments, referrals) from both eRS and Portal Provider systems and present these results on the NHS App in the form of a 'deep link'. 

Deep links sit underneath a button in the App or a jump off link. The purpose of these deep links is to take the user directly to an individual appointment/referral without having to navigate through other screens. This deep link will then take the user to the third-party portal provider. When a button is clicked, the user would see a notification page that they are being taken out of the app to the provider. 

Note: This CATR supports the risk management and approval of the NHS App Wayfinder layer only. All other components which include Aggregator, eRS and Portal Providers are out of scope of this certificate.

Date issued: 17 August 2022

(Issue 20.0) Covid Booster Broadcast Communication

Issue 20.0 of this CATR captures the risk assessment completed and approved for the Covid Booster Broadcast Communication. 

Date issued: 7 December 2021

(Issue 19.0) Availability of Patient Knows Best (PKB) test results in the NHS App

Issue 19.0 of this CATR is for PKB test results feature to be available in the NHS App. 

Date issued: 3 August 2020

(Issue 18.0) In App Messaging

Issue 18.0 of this CATR is for in App Messaging. 

In App messaging will be available on version 1.31 of the NHS App. The messages will be available to all NHS App users with at least mid-level authentication (also known as P5). This is one-way messaging only, with the message being sent from the NHS App to all users. There will be no personal data within the messages. Initially, messages sent by the service will only be related to:

  • public health content, for example updated coronavirus advice
  • NHS App release content, or content related to operational issue

Date issued: 4 May 2020

(Issue 17.0) TPP Secure Messaging

Issue 17.0 of this CATR is for TPP Secure Messaging. 

Secure messaging for TPP will go live on version 1.31 of the NHS App; this will be limited to 400 practices initially and monitored by the NHS App programme.

Secure messaging will:

  • allow a patient to send a message to a member of staff at the GP surgery
  • allow a member of staff to reply to the patient
  • allow a member of staff at the GP surgery to send a message with a document attachment
  • display a list of messages the patient has sent to the GP
  • view details of a sent message and any associated replies sent from the GP
  • display an unread message count on the message list view and clearly label unread message in the message details view
  • mean that for TPP practices the care provider can initiate a message to the patient

Date issued: 19 April 2020

(Issue 16.0) Further roll out of PKB and additional features

Issue 16.0 of this CATR is for further roll out of PKB and additional features.

PKB is currently rolled out at 4 practices within Nottinghamshire CCG. NHS App roll out will continue across the remaining 120 Nottingham CCG sites. The programme will liaise with the clinical safety team regarding further roll out based on the progress with Nottingham CCG.

For Phase 2 additional features will be rolled out to the practices, these include launch:

  • ‘Care plans’ from the Health records hub
  • ‘Medicines’ from Prescriptions hub
  • ‘Appointments’ from Appointments hub
  • library/shared links from the More menu

Date issued: 27 April 2020

(Issue 15.0) TPP Proxy access

Issue 15.0 of this CATR is for TPP Proxy access. 

TPP Proxy Access will go live on v1.31 of the NHS App, this will allow a user to get access to another patient’s GP services, including appointments, repeat prescriptions and patient record access; an example of access may be a parent’s access to a child’s record.

The intended roll out is to around 3% of TPP practices that already have proxy access enabled. There will be a gradual roll out past the 3% of practices, this will be monitored by the NHS App programme and clinical safety will be updated on the progress.

Date issued: 27 April 2020

(Issue 14.0) CSG approval of EMIS documents

Issue 14.0 of this CATR reflects the previous CSG approval of EMIS documents. 

It was decided that due to documents being part of the patient record this did not need a new CATR issuing, this position has now changed so the CATR will be uplifted. 

EMIS documents has been in the App for 6 months.

TPP documents does not use Docman. Evidence has been submitted by TPP that confirms that they implemented a change which ensures all documents are reviewed by a care provider prior to being uploaded to the patient record.

Date issued: 23 October 2019

(Issue 13.0) Further roll out of eConsult within the NHS App

Issue 13.0 of this Clinical Authority to Release (CATR) is to support further roll out of eConsult within the NHS App. 

The programme has provided an update on the eConsult roll out and stated that there have been no incidents reported during this time. eConsult has been rolled out to 8 practices. eConsult is to be rolled out to 1,300 practices, this is to support primary care patients in communicating with GPs and health professionals online.

Date issued: 27 March 2020

(Issue 12.0) NHS App integration with Patient Knows Best (PKB)

Issue 12.0 of this Clinical Authority to Release (CATR) is to support NHS App integration with Patient Knows Best (PKB). 

PKB have onboarded the NHS App by completing the Supplier Conformance Assessment List (SCAL) they have stated that they are compliant with DCB 0129 and have a safety case report and hazard log. Their CSO has been named within the SCAL.

Initial roll out will be at the following practices:

  • Roundwood Surgery - NHS Mansfield and Ashfield CCG
  • Trentside Medical Group - Nottingham North and East CCG
  • Forest Medical Group - Nottingham City CCG
  • Elmswood Surgery - Nottingham City CCG
  • Cripps Health Centre - Nottingham City CCG
  • Willowbrook Medical Practice - Mansfield and Ashfield CCG
  • Middleton Lodge - Newark and Sherwood CCG

Date issued: 27 March 2020

(Issue 11.0) NHS App Nominated Pharmacy Phase 2

Issue 11.0 of this Clinical Authority to Release (CATR) is to support NHS App Nominated Pharmacy Phase 2.

Phase 2 will allow patients to nominate a distance selling pharmacy, also known as an online pharmacy. There are an additional 25 practices in scope for phase 2, this gives a total of up to 50 practices for P1 and 2.

Date issued: 9 February 2020

(Issue 10.0) NHS App Secure Messaging (Patient to Practice Messaging)

Issue 10.0 of this Clinical Authority to Release (CATR) is to support NHS App Secure Messaging (Patient to Practice Messaging). 

Secure messaging is the ability to send patient to practice messages, the patient can select a member of staff at the practice to message. The NHS App reminds the patient that messaging should not be used for urgent advice, additional information can be found in the safety case report. The scope of secure messaging is restricted to 7% of EMIS practices; these are the practices that are already using the secure messaging functionality. 

Restricted to EMIS practices already using secure messaging.

Date issued: 17 February 2020

(Issue 9.0) NHS App Proxy Access

Issue 9.0 of this Clinical Authority to Release (CATR) is to support NHS App Proxy Access. 

Proxy access enables a parent, family member or carer to act on behalf of the patient with their access tailored accordingly by the patient and GP practice. Appointment booking, repeat medication requests and, where applicable, access to medical records, can easily be accessed by the proxy once a relative or person has been linked. The scope includes EMIS practices. Only patients at the same EMIS practice will be able to get proxy access during the initial release, currently only 1% of EMIS patients have proxy access.

The request and approval for proxy access is completed outside of the NHS App, therefore it is out of scope of this CATR.

Date issued: 12 December 2019

(Issue 8.0) NHS App Desktop version

Issue 8.0 of this Clinical Authority to Release (CATR) is to support NHS App Desktop version. 

Date issued: 2 December 2019

(Issue 7.0) NHS App Online Consultation

Issue 7.0 of this Clinical Authority to Release (CATR) is to support NHS App Online Consultation. 

Date issued: 13 November 2019

(Issue 6.0) NHS App Nominated Pharmacy function being added

Issue 6.0 of this Clinical Authority to Release (CATR) is to support the NHS App Nominated Pharmacy function being added. This CATR is for phase one of nominated pharmacy. 

The scope of phase one includes:

  • view exiting pharmacy nominations within the NHS App.
  • create new community pharmacy nomination
  • change nominations (to community pharmacy only)

Patients will not be able to nominate distance selling pharmacies, namely online pharmacies, until phase 2.

Date issued: 6 November 2019

(Issue 5.0) NHS App private beta pilot being extended to Microtest GP practices

Issue 5.0 of this Clinical Authority to Release (CATR) is to support the NHS App private beta pilot being extended to Microtest GP practices. 

Date issued: 19 October 2019

(Issue 4.0) NHS App private beta pilot being extended to Vision GP Practices

Issue 4.0 of this Clinical Authority to Release (CATR) is to support the NHS App private beta pilot being extended to Vision GP practices. 

Date issued: 7 February 2019

(Issue 3.0) NHS App private beta pilots extended scope

Issue 3.0 of this Clinical Authority to Release (CATR) is in support of NHS App private beta pilots extended scope to include a reduced age restriction to 13 and restricted availability of the NHS App on the app stores. 

Date issued: 12 December 2018

(Issue 2.0) NHS App private beta pilot being extended to TPP GP practices

Issue 2.0 of this Clinical Authority to Release (CATR) is to support the NHS App private beta pilot being extended to TPP GP practices. 

Date issued: 14 November 2018

(Issue 1.0) NHS App private beta pilot with EMIS only GP practices

Issue 1.0 of this Clinical Authority to Release (CATR), is in support of the NHS App private beta pilot with EMIS only GP practices. 

The NHS App private beta is on version 0.1.0 of the App, it will commence on 27 of September 2018 and run for a period of 3 months. The NHS App will not be available as a web version during the private beta pilot.

During the Clinical Risk Management activities, a medical device assessment was undertaken for the NHS App considering all online services within the App. The assessment determined that the surfacing of the webpage for 111 online, as a seamless workflow, meant the NHS App should be categorised as a class 1 medical device. Self-certification of the NHS App as a class 1 medical device will run in parallel with the NHS App private beta pilot.

Date issued: 21 September 2018


Disclaimer

The CATR has been approved by NHS Digital Clinical Safety Group. The approval is limited to the product defined by the name NHS App and the functionality defined within the safety case for the product. 

Unless specified otherwise within the supplier safety case and approval given by NHS Digital Clinical Safety Group, this endorsement must not be used beyond the scope of product functionality. 

Where common elements of an approved product form part of a different product offered by the supplier, a separate or updated safety case is required.


Further information

Last edited: 30 March 2023 9:45 am