BIHS is convening a UK-wide programme to support the safe, effective and scalable adoption of wearable blood pressure technologies in NHS care.
International standards remain an important reference for technical validation, but the UK challenge is how evidence translates into real clinical pathways. Our three workstreams focus on the evaluation framework, data integration and workflow, and the research and implementation route needed to move from early evidence to real-world NHS use.
The programme is now moving from kick-off discussions into active development. Across the three workstreams, there is strong alignment around the need for a staged, use-case-based route to evidence generation and adoption, rather than a single universal standard or a binary pass/fail model.
Workstream 1 - Evaluation Framework and Clinical Use
Lead: Professor Phil Chowienczyk
Purpose
To develop a proportionate UK evaluation framework for wearable blood pressure technologies, linked to intended use.
Focus
This workstream is considering how evidence should be interpreted for defined clinical use cases, recognising that wearable technologies cannot simply be treated in the same way as conventional cuff-based devices. Its role is to help define what “ready for evaluation” and, in time, “ready for supported clinical use” should mean in practice.
Current priorities
- define a staged, use-case-based evaluation framework
- clarify evidence maturity and readiness for controlled evaluation
- distinguish clearly between regulatory status, technical validation, clinical evaluation and BIHS endorsement
Workstream 2 - Data Integration and Clinical Workflow
Leads: Professor Alun Hughes and Dr Eduard Shantsila
Purpose
To define how wearable blood pressure data should flow safely and usefully into NHS-facing pathways.
Focus
This workstream is developing the data and workflow model needed to ensure clinicians receive clear, coded and clinically actionable outputs rather than raw data streams or static PDFs. It is also considering the governance boundaries between research-grade data, evaluation environments and information that should enter the clinical record.
Current priorities
- define the minimum clinically useful summary output for practice use
- explore coding and interoperability requirements, including future SNOMED alignment
- set out a safe pathway for information flow into GP and NHS systems
- support a neutral, single point of entry approach that can standardise outputs across devices and use cases
Workstream 3 - Research and Implementation Pilots
Lead: Dr Manish Saxena
Purpose
To design and test the first practical route from early evidence generation to real-world NHS implementation.
Focus
This workstream is shaping an initial pilot comparing wearable blood pressure technologies with ambulatory blood pressure monitoring in a realistic NHS-facing use case. The priority is clinical relevance: whether a wearable classifies patients correctly compared with ABPM, alongside operational learning about patient acceptability, clinician usability and implementation fit.
Current priorities
- scope the first focused diagnostic agreement study
- define the initial target population and primary endpoint
- identify suitable pilot settings and participating technologies
- support the transition from early research into broader service evaluation in practice
How the workstreams fit together
The three workstreams are designed to operate in parallel but with clear sequencing.
Workstream 1 defines what level of evidence is good enough for a given use case
Workstream 2 defines what data and clinical outputs need to look like
Workstream 3 applies both in a practical research and implementation pathway
Together, they provide the programme with three core building blocks:
- a proportionate evaluation framework
- a minimum clinically useful data model
- a phased route from early evidence generation to NHS service evaluation
Current programme emphasis
The BIHS Wearables Programme is not seeking to solve every aspect of adoption in one step. The current emphasis is on producing the practical building blocks needed to unlock funding, support credible pilot work and establish a safe route towards wider NHS use.
This includes:
- the development of an evaluation framework
- a focused research concept around diagnostic agreement versus ABPM
- an implementation pathway covering workflow, coding, summary outputs and service readiness
Important clarification
BIHS is not currently approving any wearable blood pressure device for routine clinical use.
Regulatory status, CE marking, technical validation, controlled evaluation and BIHS-supported clinical adoption are not the same thing. One of the programme’s key roles is to clarify those distinctions and support a transparent, evidence-led route for future NHS use.