ISO TS 82304-2:2021

Overview

ISO/TS 82304-2:2021 - Health software - Part 2: Health and wellness apps - Quality and reliability provides a practical framework of quality requirements and assessment for health and wellness apps. Published as an ISO technical specification in collaboration with IEC, it covers the entire app life cycle and defines a health app quality label and a score calculation method to visualize and communicate an app’s quality and reliability to manufacturers, assessors and end users.

Key topics and technical requirements

The standard organizes requirements around five high-level themes and supporting processes:

• Product information
  • Clear metadata about the app and the app manufacturer required for assessment and transparency.
• Healthy and safe
  • Health-related requirements (effectiveness, clinical risks, ethics, health benefit and societal benefit).
• Easy to use
  • Accessibility and usability requirements to ensure apps can be used by diverse populations, including low health-literacy users.
• Secure data
  • Privacy and security requirements to protect personal and health data handled by the app.
• Robust build
  • Technical robustness and interoperability to support reliable operation and integration with health IT systems.

Supportive assessment elements:

• A defined health app assessment process (quality assessment, evidence pack, report and label).
• Annex A: specification for the health app quality label.
• Annex B: method for calculating the health app quality score.
• Informative annexes (C–G) covering scope rationale, lifecycle/process recommendations, profiles (e.g., contact tracing apps), ethics, and practical uses.

Note: ISO/TS 82304-2 is focused on quality and reliability and explicitly excludes guidance on complying with medical device regulation.

Applications and practical value

• App manufacturers: use the requirements to design, document and evidence the quality, privacy, safety and usability of health apps across the life cycle.
• App assessment organizations and libraries: adopt the assessment process, evidence pack and scoring to evaluate and publish app quality reports.
• Health providers, payers and procurers: use the quality label and report to select, recommend or contract apps for care pathways and reimbursement.
• Consumers, patients and carers: rely on the label and report to compare app quality and make informed choices.

Who should use this standard

• Health app developers and product teams
• App assessment bodies and evaluators
• Healthcare organizations, insurers and policymakers
• Digital health procurement and IT teams

Relevant keywords: ISO TS 82304-2:2021, health app quality label, health and wellness apps, health software, quality and reliability, app assessment, privacy, security, usability, interoperability.