Guidance

Health app developers: the assessment process

How developers can get their health app assessed and endorsed.

Introduction

If you design and build apps for public health or the health service, you’ll need to show how they meet a set of technical criteria set out in the Digital Assessment Questions. This is the process used for apps to be made available on the NHS Digital Tools Library and will eventually be required by any national health body commissioning your product or service. Public Health England (PHE) will use it to endorse public health digital products.

The 2 approaches which may be used are:

  • self-assessment followed by the commissioning body checking the responses
  • assessment by an independent organisation

Both will adhere to the same set of criteria, and will require the assessment to be submitted to the commissioning body at the end of the process.

Advice on where to get your health app assessed

If you are planning to do a self-assessment, you can complete the full set of assessment questions to see how your product fares.

Register your interest to be assessed by PHE by emailing the Digital team at Digital@phe.gov.uk.

You can engage any one of a number of independent assessment organisations to review your product. They will evaluate how your app has been built, provide feedback to improve your submission, and eventually validate your app for a commissioning organisation.

Email the PHE digital team to find out more about assessment organisations with the relevant experience.

The assessment process

Before your app is assessed you should:

  • ensure the app is functional and ready to be reviewed
  • identify the time and people you’ll need to devote to the process, including getting specialist input from technical, operational and clinical experts to respond to questions
  • make sure you have evidence to back up your answers - ideally from an independent or third-party source, such as an academic institution
  • if using an independent assessment organisation, understand the relationship you’ll have and your obligations to them

The first stage of your self-assessment is to register with your assessor and to check that your app is in scope - as a general rule, most apps and wearables are suitable for review.

Depending on what your app offers, you may also need to register with an external body before you can continue.

Apply for a CE mark from the Medicines and Healthcare products Regulatory Agency (MHRA) if your product is classed as a medical device.

Register with the Care Quality Commission (CQC) if the app is designed to be used as part of the delivery of a health and social care service.

You’ll then need to answer some questions, which will check how well the app meets a series of criteria. Answering these successfully will mean showing that the app:

  • is technically robust and meets standards on things like security, data protection, accessibility and usability - to make sure that it’s been developed in line with best practice
  • does what it claims, and that you have the evidence to prove it

Most of the questions are mandatory. Others are optional but are designed to help you demonstrate the quality of your app or the processes behind it, and will strengthen your overall offering.

To ensure that your Intellectual Property (IP) is protected as far as possible you can ask your app assessor to sign a non-disclosure agreement (NDA).

Everyone who reviews your app should keep your commercially sensitive data private and confidential.

Content review

If your app passes the digital assessment, it will be examined in more detail to ensure the quality of any health or behaviour change content being used. They will work with a team of specialists and subject matter experts to do this. Expect them to ask you detailed questions about your initial assessment and the evidence you’ve provided to support it: you should allow time and resources for this.

You may also need to commission evidence from independent experts in specialist areas, such as penetration testing or user acceptance testing. You must complete this stage before your app can be used by the health system.

Reviewers will need to see good quality evidence that your app delivers the results you claim. If you can’t provide this, your app won’t be considered. Evidence provided by an independent evaluating body will carry more weight than your own findings.

After approval

The app must be re-assessed if you make significant changes or upgrades to its interface, look and feel, technology or audience. You must do this before public release or risk having your app withdrawn.

Contact

Email digital@phe.gov.uk for more information.

Published 9 October 2017