Part 7 of 8

Governance

Voluntary adoption, organisational application, the relationship to existing regulations and the status of MHTS as a public standard.

MHTS is an open public standard intended for voluntary adoption. Its requirements can be considered by developers, organisations and technology evaluators alongside existing professional, technical and legal responsibilities.

Voluntary Adoption

The MHTS v1.0 publication describes adoption as voluntary. Developers and organisations may choose to apply the seven standards to relevant technologies and examine whether their current practices meet those requirements. Adoption may involve reviewing:

  • Product architecture.
  • User identification requirements.
  • Data collection and tracking.
  • Accessibility during distress.
  • Intervention sequencing.
  • Engagement mechanisms.
  • Human-support pathways.
  • Public effectiveness and impact information.

Voluntary adoption does not mean that every aspect of a technology's operation is legally optional. Applicable laws and regulations remain binding independently of MHTS.

The purpose of voluntary adoption is to establish an additional commitment to the safeguards defined by the standard.

Organisational Adoption

Organisations may use MHTS in several ways.

Technology Development
Companies developing emotional-support technologies can incorporate the published requirements into product specifications and development reviews.
Internal Governance
Organisations can consider the standards when establishing policies concerning acceptable technology design and data practices.
Technology Procurement
Procurement teams may ask providers whether relevant technologies satisfy MHTS requirements and request supporting evidence.
Healthcare Evaluation
Healthcare organisations and professionals may consider MHTS safeguards alongside clinical evidence, medical-device requirements and other digital-health evaluation criteria.
Education
Educational institutions may use the standards when reviewing mental-health technologies intended for students or staff.
Research
Researchers may examine whether adoption of particular safeguards affects accessibility, trust, engagement or other relevant outcomes.

The use of MHTS within an organisation should reflect the actual scope and purpose of the technology being evaluated.

Relationship to Existing Frameworks

MHTS operates alongside established digital-health, professional and regulatory frameworks.

ISO/TS 82304-2

ISO/TS 82304-2:2021 addresses quality and reliability requirements for health and wellness applications.1

MHTS adds a distinct set of requirements focused on anonymity, behavioural surveillance, immediate distress access, dependency engineering, human escalation and public accountability. The frameworks address overlapping but different considerations.

American Psychiatric Association App Evaluation Model

The APA's App Evaluation Model helps professionals and users examine relevant app characteristics, including accessibility, privacy, security, clinical foundations and usability.2

MHTS focuses on a defined set of structural and ethical requirements rather than providing the same broader app-selection framework.

NICE Evidence Standards Framework

NICE provides an evidence framework for evaluating digital-health technologies. Its purpose concerns the evidence expected to support different types of digital-health functions.3

MHTS does not replace those evidence requirements.

Psychological First Aid Guidance

The World Health Organization's Psychological First Aid guidance establishes principles for humane, supportive and practical assistance following highly distressing events.4

MHTS concerns the design and operation of technologies, including relevant technologies applying Psychological First Aid teachings or methods. The two address different aspects of support.

Data Protection

Applicable privacy legislation governs the lawful processing of personal information.5

MHTS establishes additional technology requirements, including the prohibition on identifiable personal data capture and behavioural surveillance. Compliance with privacy law does not automatically establish conformance with MHTS.

Medical-Device Regulation

Certain digital mental-health technologies may qualify as medical devices. Their classification depends on applicable jurisdictional rules, intended purpose and functionality.6

MHTS does not replace the resulting regulatory obligations.

MHTS is published as a voluntary public standard. It should not be represented as legislation or as a universal regulatory requirement.

An organisation's legal responsibilities depend on the jurisdictions in which it operates, the purposes of its technology and the activities it performs. For example:

  • A product intended to diagnose or treat a medical condition may fall within medical-device regulations.
  • A service processing personal health information may be subject to specific privacy and data-protection requirements.
  • Marketing claims may also be subject to consumer-protection law.

These obligations exist independently of MHTS.

  • Adopting the MHTS requirements does not establish compliance with every applicable law.
  • Equally, compliance with applicable law does not automatically mean that a technology meets the additional requirements of MHTS.

Organisations should evaluate both separately.

Standard Ownership & Governance

MHTS is an initiative of the International Mental Health Infrastructures (IMHI) Group. IMHI publishes the standards through the official MHTS website.

The publication provides the authoritative wording of the seven requirements and identifies the current version. The standards are publicly accessible, allowing developers, researchers, organisations and other interested parties to examine them.

The published materials should be used as the reference for determining what MHTS requires.

No independent certification or accreditation process should be assumed solely from the existence of the public standard or its self-assessment tool.

For the current official publication, visit: mhts.org

Published Version

The published version documented here is MHTS v1.0. It contains seven standards:

  1. Anonymous by Design
  2. No Behavioural Surveillance
  3. Frictionless Access in Distress
  4. Stabilisation Before Interpretation
  5. No Dependency Engineering
  6. Human Escalation Supremacy
  7. Public Accountability

The version is identified on the official standards page. Readers should consult that publication when confirming the currently applicable wording.

This documentation does not presume the existence of unannounced revision, certification or governance procedures.