Clinical safety and regulatory information (including intended use)

Introduction

MyWay Health is a world-leading platform to self-manage and education around various long-term conditions.
The app is a Medical Device Class I UK MDR (going through approval to become a Class IIa EU MDR) in the UK
with a UKCA mark. Our MHRA number is 9595; and GMDN Code for the product is 44106.

The app and its contents have been developed by co-founders, Dr Debbie Wake (a consultant diabetologist and expert on use of data to support patients)
and Dr Scott Cunningham (an academic and expert on data analysis, interoperability and safe managemengt of NHS data at scale),
along with a multi-disciplinary education team including an educational expert, two additional diabetes consultants,
a diabetes specialist nurse and a patient user. Included and consulted on an ad-hoc basis are diabetes specialist dieticians
with significant experience supporting multi-ethnic communities.

The platform uses behaviour change tools (such as goal setting, pre and post course and pre-clinical questionnaires)
which is closely aligned with the Health Belief model described in a NICE paper –
PH6: https://www.nice.org.uk/guidance/ph6/resources/behaviour-change-taylor-et-al-models-review2 and is aligned to the year of care personalised care approaches.

Evidence of the app’s use and benefits

The Platform is designed to assist in supporting the management of long-term conditions, optimising care pathways,
promoting behaviour change, and improving clinical outcomes through personalised decision support and self-management tools:

  • Personal health record
  • Risk calculation tool
  • Education materials and courses

MyWay Health is NHS Digital Technology Assessment Criteria (DTAC) certified and the highest-ever Orcha rated Diabetes health app.

Intended use

MyWay Health is a personalised health tool to help prevent, monitor, educate and advise on the long-term management of diabetes mellitus,
cardiovascular disease and associated cardio-metabolic conditions.

Contraindications (who should not use the app)

Please speak to a healthcare professional before starting any change you your lifestyle.
Please do not use the app if you are:

  • Individuals under 18 years of age
  • Having a sudden medical emergency
  • Have, or are at risk of, medical conditions that are not diabetes, cardiovascular disease or associated conditions
    (including but not limited to living with overweight or obesity, some forms of kidney disease, some forms of liver disease).

Users should consult a healthcare professional before making any changes to treatment or lifestyle.

Evidence base for the app

The MyWay platform is supported by a substantial body of peer-reviewed research demonstrating its usability,
clinical impact, and effectiveness in supporting diabetes self-management and education.
Below is the consolidated list of published evidence for the platform.

Key References

  • Baxter M et al (2025) Impact on diabetes-related health outcomes using a digitally-enabled diabetes self-management platform
    in Somerset, UK: An interrupted time-series analysis. DOI: 10.1186/s12938-019-0635-4
  • Cunningham, S et al (2021) Cost-utility of an online education platform and diabetes personal health record:
    analysis over ten years accepted for Journal of Diabetes Science and Technology. DOI: 10.1177/19322968211069172
  • Conway NT et al (2018) My Diabetes My Way: User Experiences of an Electronic Personal Health Record. Jn of Diab Sci and Techn. DOI:
    10.1177/1932296818818837
  • Gardner C et al (2023) Evaluation of prototype risk prediction tools for clinicians and people living with type 2 diabetes
    in North West London using the think aloud method. Digital Health; DOI: 10.1177/20552076221128677

These papers demonstrate:

  • Patient Reported Outcomes including: knowledge, confidence, quality of life and ability to management their long-term conditions (p<0.01)
  • Metabolic outcomes including: HbA1C, Cholesterol, Weight, Blood Glucose (p<0.01)

And reductions in

  • Acute Admissions/ Complications/ emergency visits
  • Clinic Appointments
  • Long Term Complications such as Heart Disease, Amputations, Strokes,
  • Medication requirements

Other references

The MyWay platform patient-facing element has been evaluated through a large number of peer reviewed research studies to ensure it is useful, safe, effective, and delivers benefits.

In summary, the features/ tools have been shown to improve patient reported outcomes such as quality of life, knowledge, self-confidence to self-manage and improve metabolic health outcomes (including HbA1C, Cholesterol, Weight, Blood pressure), reduces clinic appointments and acute admission and save health services money; through efficiencies, reductions in clinical visits and a reduction in major complications such as heart attacks and other major health events. An evidence summary is represented at www.mwdh.co.uk/evidence and some key publications explaining the evolution and outcomes of the MyWay product are highlighted below.

• Cunningham S G, et al (2013) Patients’ expectations of electronic record access. British Journal of Diabetes and Vascular Disease.

• Cunningham SG, et al. (2013) My Diabetes My Way: an electronic personal health record for diabetes. British Journal of Diabetes and Vascular Disease 13(3), 143-49. DOI: 10.1177/1474651413493336– https://diabetesonthenet.com/diabetes-primary-care/my-diabetes-my-way

• Cunningham SG et al(2014) My Diabetes My Way: Providing online support for diabetes self-care in Scotland Diabetes & Primary Care, 16(3), 123–128[GU1]

• Cunningham SG, et al (2015) My Diabetes My Way: supporting online diabetes self-management. Diabetic Medicine; 32:3-3 DOI: 10.1186/s12938-019-0635-4

• Wake D.J et al (2016) My Diabetes My Way: An Evolving National Data Driven Diabetes Self-Management Platform. Journal of Diabetes Science and Technology Aug 22;10(5):1050-8. DOI: 10.1177/1932296816648168

• Wake D.J, et al (2016) MyDiabetesMyWay: An Evolving National Data Driven Diabetes Self Management Platform Jn of Diab Sci and Techn;10(5):1050-8. DOI: 10.1177/1932296816648168

• Cunningham SG et al (2019) My Diabetes My Way: supporting online diabetes self-management – progress and analysis from 2016″ (BMEO-D-17-00369R3) BioMedical Engineering OnLine; 18 (13) DOI: 10.1186/s12938-019-0635-4

• Mackenzie S et al (2020) Massive open online course for type 2 diabetes self-management: adapting education in the COVID-19 era. BMJ-Innovations: DOI: 10.1136/bmjinnov-2020-000526

• Mackenzie SC et al (2021), Follow-Up of a Massive Open Online Course in Type 2 Diabetes Self-Management Education. J Diabetes Sci Technol.; 15(4):976-977 DOI: 10.1177/1932296821997178

• Mackenzie SC et al (2022) Education at Scale: Improvements in Type 1 Diabetes Self-Management Following a Massive Open Online Course (MOOC). Diabetic Medicine 39(8):e14842. DOI: 10.1111/dme.14842

• Shields C et al. (2022) User-centered design of a novel risk prediction behaviour change tool augmented with an Artificial Intelligence engine (MyDiabetesIQ): A sociotechnical systems approach. JMIR; 8;9(1):e29973 DOI: 10.2196/29973

• Shield S. et al (2023) Continuing the quality improvement of an electronic personal health record and interactive website for people with diabetes in Scotland (My Diabetes My Way) Diabetic Medicine DOI: 10.1111/dme.15085

• Mackenzie SC et al (2024). Digitising diabetes education for a safer Ramadan: Design, delivery, and evaluation of massive open online courses in Ramadan-focused diabetes education. Primary Care Diabetes; 18(3):340-346 PCD-D-24-00003R1; DOI: 10.1016/j.pcd.2024.03.002

• Kirkwood JR et al (2024) The User-Centered Design of a Clinical Dashboard and Patient-Facing App for Gestational Diabetes. Jrn Diab Sci Tech (in submission) DOI: 10.1177/19322968241301792

Clinical and technical safety

We are committed to clinical and technical excellence. Effective application of clinical risk management, clinical risk and safety is managed by MWDH’s Clinical Safety Officer, an appropriate, practicing physician skilled and experienced to provide safety and governance. All Clinical guidance and references within the platform are aligned to National Institution for Health and Care Excellence (NICE), and/or aligned to UK government standards on health living, and/or aligned to the World Health Organisation (WHO) or Scottish Intercollegiate Guidelines Network (SIGN) in Scotland.

The app and all education resources have been evaluated, approved and validated by the Clinical Team, led by the Clinical Safety Officer.

  • The Clinical Safety Officer is Dr Alex Bickerton
  • The Data Protection officer is Dr Scott Cunningham

They can be contacted through our Contact us form or by emailing support@mwdh.co.uk

Communications and peer support

All peer-to-peer communications (community, comments) are moderated to ensure a safe, inclusive, peer-to-peer community. A team of human operators are moderators of the comments. There are also algorithms and filters to remove spam and/or offensive content. All communications within the platform are logged, and audited weekly. Some posts may be removed or hidden to ensure continuity of the service.

Risk Hazard and Management Process

MWDH is committed to clinical and technical safety. As ISO27001 and ISO13485 certified and NHS DSPT compliant company, MWDH has embedded management and clinical risk systems in place to ensure the technical security, clinical safety and quality of its systems and the data within it.

All data collected, processed and stored is done so using AES-256 encryption in-transit and at-rest in the UK territory in accordance with applicable data protection and information security requirements, with appropriate technical and organisational controls in place to ensure confidentiality, integrity, and availability. Access to infrastructure is limited to named individuals, and their access is fully audited.

MWDH has a clinical risk measurement, evaluation and management process overseen by the Clinical Safety Officer. The risk/hazard assessment process follows MWDH’s standard Clinical risk Management System approach, which is compliant to DCB0129, DCB0160 and ISO 14971. Risks may also be identified during development and use of the MyWay Health such as discovery during design of features or enhancements, feedback, participant engagement, testing of amended functionality, ad-hoc testing of live service, or reporting of an incident or problem within the live service. The Risk Management File (RMF) that includes the Risk Plan, Hazard log, Risk Management Report and Clinical Safety Case Report is maintained and updated by the Clinical Safety Team at least annually or when the product undergoes substantial changes.

The risk management process is as follows:

For each identified Hazard, the following information will be defined and recorded:

  • hazard number; name and description
  • potential clinical impact
  • possible causes
  • existing controls – identified existing controls or measures currently in place and will remain in place post-implementation mitigating against the hazard.

Each Hazard is reviewed by the Clinical Safety Team and appropriate stakeholders to estimate and evaluate clinical risk and controls and record the outcome. The clinical risk for each identified hazard is estimated, based on the severity of potential harm and the likelihood of occurrence. Where residual risks remain and are above the acceptance criteria, they are evaluated against the expected user or clinical benefits of the platform to ensure an overall positive benefit–risk profile. The estimation process follows established and documented safety processes defined in MWDH’s QMS.

MWDH continually monitors its services as part of its post-market surveillance (PMS) activities to ensure ongoing safety and performance. This includes monitoring of incidents, user feedback, system performance, and emerging risks, with findings fed back into the risk management process where appropriate. Where required, corrective and preventive actions (CAPA) are initiated and tracked to resolution. The education resources are reviewed at appropriate intervals (every 1-3 years depending on clinical importance) to ensure they are up-to-date with latest developments, with additional ad hoc reviews, when changes are identified via NICE and other guidance updates or where new clinical evidence becomes available.

Users are encouraged to report any safety concerns, incidents, or unexpected outputs via the contact details provided. If you would like to raise a risk or hazard, please contact us on support@mwdh.co.uk. All reported issues are assessed and managed in line with MWDH’s incident management and clinical safety processes with relevant findings incorporated into ongoing risk management, CAPA and post-market surveillance activities.

Risks associated with the app

Safety of apps is a emerging issue. MWDH has conducted several studies and continues to research the benefits and risks related to app use.

Do not use the app if you meet any of the conditions in the contraindications.

Where data is sourced from external systems, delays or discrepancies may occur depending on the availability and quality of those systems.

The accuracy of outputs is dependent on the accuracy and completeness of input data, including data entered by users or received from connected systems.

Incorrect interpretation or use of information provided by the app may result in inappropriate self-management or delay in seeking appropriate medical care.

This app is not intended to replace the relationship with your doctor/Health Care professionals. Follow the advice of your doctor. If you become pregnant, then please consult your healthcare professional, as the advice within the app may no longer be applicable.

General wellbeing advice (non-product advisory): Use of mobile devices for prolonged periods may contribute to eye strain or sleep disturbance. Users are encouraged to take regular breaks and follow general screen-use best practices.

Contact Information

For questions, feedback, or to report a safety concern, please contact: support@mwdh.co.uk