PAS 277-2015 PDF

Full title and description

STB PAS 277-2015 — Health and wellness apps. Quality criteria across the life cycle. Code of practice. This entry represents the STB (national) adoption/availability listing of the BSI Publicly Available Specification PAS 277:2015, a code of practice giving quality criteria and lifecycle guidance for health and wellness mobile and web applications (including native, hybrid and web-based apps and apps associated with wearables and other health equipment).

Abstract

PAS 277:2015 provides recommended quality criteria and practical guidance to developers, assessors and procurers of health and wellness apps. It covers the full app project life cycle — planning, development, testing, release, maintenance and monitoring — and addresses functionality, usability, accessibility, data protection, security, fitness for purpose and post-release monitoring. The PAS does not itself determine whether an app is a regulated medical device; developers remain responsible for checking applicable regulatory requirements.

General information

• Status: National STB listing shown as active; the originating BSI PAS 277:2015 was published in 2015 and was later withdrawn by BSI on 25 October 2023 (work has been taken forward at international level by ISO/TC 215 in ISO/TS 82304-2).
• Publication date: Original PAS publication: 30 April 2015 (PAS 277:2015). STB listing date: 2015 (adoption/listing identifies the 2015 edition).
• Publisher: British Standards Institution (BSI) — original PAS author; STB listing/availability recorded via national/third‑party distributors (STB designation indicates national availability/adoption listing).
• ICS / categories: 03.120.01 (Quality in general); 35.080 (Software); 35.240.80 (IT applications in health care).
• Edition / version: 2015 (PAS 277:2015).
• Number of pages: 36 pages (original PAS 277:2015).

Scope

The document applies to the development and life‑cycle management of health and wellness apps intended for patients, carers, health professionals and the wider public. It sets out quality criteria that can be applied irrespective of whether an app is commercially released or provided free of charge, and for apps linked to other systems or devices. It explicitly excludes guidance on how to determine whether an app is subject to medical device regulation or other specific legal/regulatory regimes; developers are expected to check and follow applicable regulations.

Key topics and requirements

• Quality criteria across the app life cycle: planning, requirements, design, development, verification and validation, release, maintenance and retirement.
• Usability and accessibility as critical quality properties (user stories, case studies and usability testing).
• Data protection, privacy-by-design and security considerations for user data and health information.
• Testing, verification and monitoring of fitness for purpose (including intermittent network conditions and device variability).
• Release management, versioning and user notification of updates; lifecycle support and post‑release monitoring.
• Guidance to help developers identify when additional regulatory/compliance steps may be needed (note: PAS itself does not substitute regulatory determinations).
• Compatibility considerations for native, hybrid, web apps and apps linked to wearables or other health equipment.

Typical use and users

Intended users are app developers, software quality managers, product owners, clinical safety leads, procurement officers, app assessment organisations, academic researchers and health service digital teams who need practical criteria and a lifecycle‑based approach to produce reliable, usable and secure health and wellness applications. It is also useful for organisations that assess or curate apps for recommendation or procurement.

Related standards

PAS 277 references and aligns with several software, medical device and quality management standards that are commonly used alongside it, for example: BS EN 62304 (medical device software lifecycle processes), BS EN 62366 (usability for medical devices), ISO 14971 (risk management for medical devices), ISO 13485 (medical device quality systems), ISO/IEC 25010 and ISO/IEC 25012 (software quality and data quality models), and ISO/IEC 90003 (application of ISO 9001 to software). It also informed the development of the international technical specification ISO/TS 82304‑2 (health and wellness apps — quality and reliability).

Keywords

health apps, wellness apps, mobile health, mHealth, app quality, software lifecycle, usability, accessibility, data protection, security, app monitoring, PAS 277, STB adoption, BSI, ISO/TS 82304‑2.

FAQ

Q: What is this standard?

A: STB PAS 277-2015 is the STB‑listed/adopted entry for PAS 277:2015 — a BSI Publicly Available Specification giving quality criteria and lifecycle guidance for health and wellness apps. It provides a code of practice for developers and assessors.

Q: What does it cover?

A: It covers quality criteria across the entire app lifecycle (planning, design, development, testing, release, maintenance and monitoring), addressing usability, accessibility, security, data protection and fitness for purpose. It does not itself determine whether an app is a regulated medical device.

Q: Who typically uses it?

A: App developers, product and quality managers, clinical safety leads, procurement teams, app assessors and organisations involved in recommending or curating health apps. It is intended to be practical and developer‑focused.

Q: Is it current or superseded?

A: The original PAS 277:2015 was published in 2015; BSI recorded that PAS 277:2015 was withdrawn on 25 October 2023. At the international level, the subject was progressed into ISO/TS 82304‑2 (published July 2021) which provides an international technical specification for health and wellness app quality and a quality‑label approach. Users should prefer ISO/TS 82304‑2 for current international guidance and check national status of STB listings before relying on a withdrawn national copy.

Q: Is it part of a series?

A: PAS 277 is a standalone PAS from BSI but sits in the broader ecosystem of health‑software standards and influenced ISO/TS 82304‑2. Implementers commonly use it alongside device‑software and quality management standards (e.g., EN/ISO 62304, ISO 14971, ISO 13485 and ISO/IEC 25010).

Q: What are the key keywords?

A: health apps, wellness apps, mHealth, app quality, software lifecycle, usability, accessibility, data protection, security, ISO/TS 82304‑2, PAS 277.