Resources
We have collated the most recent resources for anyone seeking to understand the steps to getting your digital, technology or medical device solution to the health and social care market in the UK. These help you to understand the required standards, evidence to show effectiveness and other steps needed to sell to the NHS and social care.
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For grant funding opportunities for innovations within healthcare check the following routes:
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NICE, the National Institute for Clinical Excellence has developed a set of evidence standards for digital health technologies.
The Department of Health and Social care has produced useful guidance on using a budget Impact analysis to evaluate your digital health solution.
NICE have produced a guide to describe the two main forms of economic analyses specific by NICE for producingcost consequences and budget impact analyses.
Evaluation toolkit created by NHS and research organisations in the West of England to help anyone better understand how to devise and develop an evaluation or evidence gathering within healthcare projects.
NIHR’s Research Design Service provides advice and support for anyone seeking to design a research project including feasibility studies and clinical trials.
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To understand regulatory approvals for medical devices to be placed on the UK and EU markets see the government guidance and find more information on the Medicines & Healthcare Regulatory Agency MHRA website.
You may need to register with Care Quality Commission (CQC) if you provide, or intend to provide, health or adult social care activities in England even if the activity is delivered remotely or online. This is a legal requirement under the Health and Social Care Act 2008.
For artificial intelligence technologies this guidance issued by Department for Science, Innovation & Technology in February 2024 for regulators is useful to understand the current position.
NHS England have developed a self-assessment tool Digital Technology Assessment Centre (DTAC) which demonstrates to NHS stakeholders that digital and technology solutions meet clinical safety, data protection, technical security, interoperability and usability and accessibility standards.
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If your technology solution will collect and store any patient data, you'll need to meet data protection and data security standards. A number of quality assurance standards help to meet the requirements:
ISO/IEC 27001 information security, cybersecurity and private protection.
ISO/IEC 27002 builds upon 27001 to provide further guidelines for selecting and implementing security controls.
Cyber Essentials Scheme is a government backed self-assessment certification that helps to protect your organisation against cyber-attack. Certain types of public contracts require organisations to hold Cyber Essentials or Cyber Essentials Plus certification.
The NHS Data Security and Protection Toolkit is an online self-assessment tool that enables companies to measure and publish their performance against the National Data Guardian’s ten data security standards.
Undertaking a Data Protection Impact Assessment (DPIA) involves systematically identifying and mitigating against potential data protection risks to an acceptable level before using or sharing (processing) data that identifies individuals (personal data). Under the General Data Protection Regulations (GDPR) there is an obligation that a DPIA must be completed before carrying out data processing that is likely to result in high risk to personal data. Usually, health and social care organisations will have their own DPIA template that once completed is reviewed and signed off by assigned approver within the organisation.
The NHS Health Research Authority has provided guidance from a research perspective in the development of data-driven technologies and outlines the legal requirements for using health and care data.
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Read this article about this 2022 research which outlines the potential implicit bias, under-representation and inequalities within digital health and technology solutions.
Health Innovation Kent, Surrey and Sussex have produced a guide to help innovators consider how to ensure health equity in designing, developing and deploying their innovation.
Read about the findings and recommendations of the independent review into racial, ethnic and other factors leading to unfair biases in the design and use of medical devices.
Another way to reduce digital exclusion is by meeting the Web Content Accessibility Guidelines these are an internationally recognised set of recommendations for improving web accessibility.
NHS England have produced a framework for inclusive digital healthcare to give advice on designing and implementing inclusive digital approaches and technologies within NHS services
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In the UK, procurement frameworks are pre-established agreements or contracts between one or more suppliers and a public sector body including NHS organisations. These buyers can use these frameworks to purchase products or services without going through a full tender process each time.
Suppliers are pre-approved for inclusion in the framework, based on a competitive tendering process that evaluates quality, capability, price etc. Public sector buyers can award contracts directly to suppliers within the framework or run a mini-competition between the listed suppliers to ensure the best fit for specific needs.
Dynamic Purchasing Systems – open at any time for unlimited number of supplier to join. Whereas other procurement frameworks are open for applications every few years.
The most relevant for digital and technology solutions for health and social care include:
London Procurement Partnership DPS
One London Local Health and Care Record DPS
NHS England Health Systems Support Framework
Contracts Finder is a free UK government website designed to help businesses, particularly smaller businesses, find and bid for public sector procurement opportunities. It provides a central hub where public sector organisations post information about contract opportunities, contract awards, and pipeline opportunities.