Regulatory updates on digital mental health technologies

Regulatory updates on digital mental health technologies

Digital mental health technologies (DMHT) are a growing market, with mental health applications being capable of providing relief for both patients and practitioners. 

DMHTs are software and digital products that support mental health and wellbeing. They include AI-powered assessments, mental health apps and virtual reality therapy; all of which are increasingly being used by the NHS and individuals.

The technologies can have a broader reach, through using interactive and text-based tools that develop through artificial intelligence and machine learning and reduce the need for practitioner input. 

With the increasing demand for and popularity of DMHTs, both the Medicines and Healthcare products Regulatory Agency (MHRA) and NHS England (NHSE) have recently published guidance on these technologies.

MHRA guidance

The MHRA published new guidance on 3 February 2024 applicable to digital mental health technologies placed on the UK market. 

This guidance was developed as part of a Welcome funded project, led by the MHRA in partnership with NICE, which launched in May 2023. This project consists of four work packages: Scoping and stakeholder engagement (which has now concluded), Qualification, and Clinical evaluation and post market surveillance. Future works will include a continuation of extensive national and international engagement with subject matter experts, international regulators and approved bodies. Currently market research exploring how users identify and report adverse events specific to the use of DMHTs is underway. The results of the Wellcome funded project will then include various published guidance documents, such as this guidance. 

The digital mental health technologies guidance seeks to help manufacturers meet UK medical devices regulations, as well as ensuring the technologies are effective and acceptably safe to improve outcomes for people with mental health conditions.

This new guidance forms part of the MHRA’s programme of regulatory change to improve patient safety, improve patient access to medical devices and to ensure the UK remains an attractive market for medical technology innovators.

Before bringing their technologies to market, manufacturers should review the guidance to ensure they are compliant. 

The guidance focuses on three main areas:

1. Defining the intended purpose and functionality of DMHT: The intended purpose and functionality are important in characterising the device and thereafter important in determining qualification as a Software as a Medical Device (SaMD), risk assessment, evidence generation and market adoption. 

2. Which types of DMHT qualify as Software as a Medical Device (SaMD) under the UK law: Considering whether the device has a medical purpose (performs a clinical task and targets clinical conditions/symptoms) and sufficient functionality will determine whether the DMHT qualifies as a SAMD. Note the guidance states that even if a product is intended for a medical purpose, if it has “low functionality” then it will not qualify as a medical device. If the DMHT does qualify as a SaMD it is required to meet the requirements of the medical device regulations. 

3. Classification of DHMT: If the device is a SaMD, then the DHMT must be classified.  Classification is based on risk, with Class I being for the lowest risk medical devices and Class III for the highest. 

NHSE’s principles for using digital technologies

NHSE has published eight principles to guide decision-making on procurement, implementation and use of digital technologies in mental health inpatient settings. The principles are to be applied across all NHS-funded mental health inpatient service types, including but not limited to children, older adults, patients with learning disabilities and specialised mental health inpatient services.

The principles are:

1. Human rights approach: Any use of digital technology will support a human rights approach to care

2. Consent and capacity: Any decision to use digital technologies and to collect and store patient data from the use of such technologies must be based on consent from the patient (or a person lawfully acting on their behalf) or be taken following a best interests decision-making process

3. Equity of Access: Patients’ opportunities to access available digital technologies to enhance their care and treatment must be equitable

4. Co-production: Co-production must occur at procurement, testing, implementation and evaluation of all digital technologies

5. Therapeutic and personalised care: Digital technologies for care, treatment and safety must enable inpatient settings to provide therapeutic and personalised care as set out in the culture of care standards

6. Safety planning: Safety planning for patients must always be personalised and co-produced; digital technologies must only be used to help manage safety risks if deemed to be proportionate to the need

7. Evidence base: Providers must adopt a process for assessing the evidence base of any digital technology prior to procurement and implementation, and must be able to demonstrate how the evidence base was taken into account in any decision made to procure and implement the technology

8. Treatment outcomes: Providers must have a process of regularly measuring the impact and benefit of the use of any digital technology on patients’ care and treatment outcomes

The purpose of these principles is to assist clinicians in considering whether use of DMHTs is the “most appropriate, effective and least restrictive” method of treatment, and therefore whether to implement such technologies, with a focus being on the need to balance patient care with human rights.

Our team are able to support you with regulatory guidance on these and other medical devices, whether you are looking to take your product to market or procure new technologies into your healthcare practice. Please contact us today to discuss any queries you may have.