Clinical safety and regulatory information (including intended use)

Gro Health is a world-leading behavioural change platform that is used to self-manage physical and mental health and wellbeing. The app is a Medical Device (Class I MDD; Class IIa MDR awaiting notified body approval) in the UK and Europe with CE mark. Our MHRA number is 8939.

The app and its contents has been co-developed with behavioural change experts (led by award-winning researcher Charlotte Summers), clinicians and healthcare professionals to ensure it meets the needs of service users. The contents of the app have been approved by QISMET for the provision of self-management structured education (QIS 2020 and SS2Q).

Intended use

Gro Health is intended for use by adults aged 18 or over with any of the following approved indications:

  • Weight management (behavioural and specialist) including those with cardiometabolic risk factors, with PCOS, requiring menopause-related weight management and post-bariatric surgery weight maintenance
  • Prediabetes
  • Type 2 diabetes
  • Non-alcoholic fatty liver disease
  • Cardiovascular risk factor optimisation and cardiac rehabilitation

Gro Health HeartBuddy intended for adults aged 18 years or older who are enrolled in a structured cardiac rehabilitation pathway and remain under the care of a registered cardiac rehabilitation service or appropriately qualified clinician.

HeartBuddy provides structured cardiac-rehabilitation-specific education, activity progression, symptomtracking and adherence support. It is delivered in conjunction with, and under the supervision of, the patient's cardiac rehabilitation team.

Eligible patients may include adults with or following:

  • Acute coronary syndrome, including ST-elevation myocardial infarction, non-ST-elevation myocardialinfarction or unstable angina
  • Coronary revascularisation, including percutaneous coronary intervention or coronary artery bypassgraft surgery
  • Chronic heart failure, where clinically stable and receiving appropriate medical therapy
  • Stable angina
  • Atrial fibrillation, where cardiac rehabilitation forms part of the agreed clinical pathway
  • Heart-valve repair or replacement
  • Electrophysiology procedures, including cardiac pacing, device implantation or catheter ablation
  • Other clinically recognised indications for cardiac rehabilitation, where inclusion is considered appropriate by the responsible clinical team

As part of the programme, HeartBuddy may also support the management of relevant cardiovascular and cardiometabolic risk factors, including:

  • Prediabetes and type 2 diabetes
  • Blood pressure monitoring and hypertension risk-factor optimisation
  • Lipid monitoring and dyslipidaemia management support
  • Smoking cessation
  • Weight, nutrition and physical activity optimisation
  • Medication adherence and other recommended self-care behaviours

Contraindications (who should not use the app)

Gro Health is not intended for and must not be used for:

  • Diagnosis of any medical condition
  • Autonomous clinical decision-making
  • Treatment of Type 1 Diabetes Mellitus
  • Management of Long COVID / Post-COVID conditions
  • Emergency medical care
  • Management of any condition outside the approved indications listed above
  • Diagnosis of any cardiac or non-cardiac condition
  • Emergency or acute cardiac care
  • Continuous or real-time physiological monitoring
  • Autonomous clinical decision-making, diagnosis, risk stratification or treatment recommendations
  • Interpretation of electrocardiograms, cardiac rhythms, arrhythmias or suspected acute cardiac events
  • Autonomous initiation, discontinuation, adjustment or titration of cardiac medication - any medication changes must be directed by an appropriately qualified healthcare professional
  • Use in clinically unstable patients who require immediate assessment, continuous monitoring or moreintensive clinical supervision than the programme can provide

Clinical and technical safety

We are committed to clinical and technical excellence. DDM’s services are delivered in compliance with clinical safety requirements: NHS Data Security & Protection Toolkit , DSCN 14/2009, DCB0129 and DCB0160. Effective application of clinical risk management, clinical risk and safety is managed by the DDM'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 nationally accepted guidelines. Citations for all claims are available on request.

The app has been evaluated, approved and validated by the Clinical Team, led by the Clinical Safety Officer.

  • The Clinical Safety Officer for this intervention is Dr Amit Kaura.
  • The Caldicott Guardian is Michaela de la Fosse.
  • The Data Protection Officer is Amar Singh.

All can be contacted here.

Communications and peer support

All peer-to-peer communications (community, 1-to-1 coaching, comments) are moderated to ensure a safe, inclusive, 24/7 peer-to-peer community. A team of human operators are moderators of the forum. There are also algorithms/filters to prevent spam and/or offensive content. All communications within the platform are logged at event level and audited weekly. Some posts may be removed or hidden to ensure continuity of the service.

Risk and hazard management process

DDM is committed to clinical and technical safety. As ISO27001 and ISO20000 accredited providers, DDM 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 utilising AES-256 encryption in-transit and at-rest in the country of participant signup. The transfer of data is via network only Transfer Layer Security (TLS) 1.2 only. This includes the transmission of data from DDM services to its hosts (Microsoft Azure). Remote access to infrastructure holding data is monitored on a daily basis.

DDM has a clinical risk measurement, evaluation and management process overseen by the Clinical Safety Officer. The risk/hazard assessment process follows DDM’s standard Clinical Risk Management System approach. Risks may also be identified in other ways during the development and use of the Gro Health such as discovery during design of a solution by supplier or NHS Organisation; participant engagement; feedback; in-app message; testing of amended functionality; ad-hoc testing of live service functionality; reporting of an incident or problem within the live service; and identification by a member of staff within the supplier or NHS Organisation.  A full Hazard Log is maintained and updated by the Clinical Safety Team.

For each identified hazard, the following information will be defined and recorded as: hazard number; name and description; potential clinical impact, possible causes and existing controls – these are identified existing controls or measures that are currently in place and will remain in place post-implementation that provide mitigation again the hazard, i.e. will be used as part of the initial Hazard Risk Assessment. Each Hazard is reviewed by the Clinical Safety Team and appropriate stakeholders to estimate and evaluate clinical risk and controls, and record the outcome. For each identified hazard, estimation is made of the clinical risk. The estimation process follows that established by the safety processes defined in SCCI 0129. All and any apps and/or products belonging to third parties that are included within a release must be assessed thoroughly.

DDM continually monitors its services. The contents of the app are reviewed every month by the Clinical Safety Team, or as peer-reviewed evidence emerges. In-app telemetry and feedback sent to our support team (in-app or on the web) helps us to identify and address inequities and inequalities in engagement and/or health outcomes.

If you would like to raise a risk or hazard, please contact us.

Risks associated with the app

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

Unless you have been referred to the app by a qualified healthcare professional, do not use the app if you are diagnosed with any of the conditions listed under Contraindications.

Please consult your doctor before using this app. The app is not intended to replace the relationship with your doctor/physician. Follow the advice of your doctor.

Risks associated with the use of the app for participants with type 2 diabetes taking medications are hypoglycemia and tiredness. People with hypertension (high blood pressure) taking hypertensive medications may experience dizziness. Do not use the app if you are at risk of problems resulting from changes to your diet or activity. Risks identified by participants with polycystic ovarian syndrome are pregnancy. Risks identified for participants with long COVID are tiredness and fatigue; please go at your own pace and consult your doctor if you feel unusually tired.

If you become pregnant while using the app, there may be implications on the way the app could help you. Please consult your healthcare professional.

Blue light from phones and tablets can cause eye strain and speed up blindness. It's also not advised to stare at your phone in the dark. Try not to use your phone before bed. The blue light emitted by your phone can affect the production of the hormone which controls your sleep-wake cycle, or circadian rhythm. This can disrupt your sleep. Find more information in the Sleep area of the Gro Health app.

Be aware that by using a mobile phone and holding it consistently in your hand, and when moving the thumb rapidly over the keypad can put a great deal of strain on tendons in the arm and cause repetitive strain injury (RSI).