# Safety at Healthily

__V1.0 - September 2020__
*Author: Professor Maureen Baker, CBE, Chief Medical Officer*

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At Healthily your safety is our primary concern. We’ve invested a great deal of time and resources to ensure that our products and services are medically assured and safe.

Our Smart Symptom Checker (SSC) is developed by our in-house team of  10 medically certified doctors who all practice medicine in the UK’s National Health Service and a team of data scientists who are experts in augmented intelligence. We do not use patient data to create the tool.

This team uses a combination of [decision trees](https://en.wikipedia.org/wiki/Decision_tree), [bayesian networks](https://en.wikipedia.org/wiki/Bayesian_network), [neural networks](https://en.wikipedia.org/wiki/Neural_network) and [natural language programming](https://en.wikipedia.org/wiki/Natural-language_programming) to create one of the safest self-assessment triage tools on the market. All the data on symptoms, conditions and prevalence is taken from reputable sources where available.

The purpose of Healithly’s SSC tool is to calculate probable outcomes based on your reported symptoms and then to guide you to your best next steps.
For example, if Healthily calculates the possible cause of your symptoms is worrying, it will suggest seeing a doctor within 12 or 48 hours, depending on the seriousness of the condition. If Healthily calculates you are safe to care for yourself we will also give you information on what to do if your symptoms change or get worse.

In healthcare this is called triage and should not be confused with diagnosis. Healthily cannot diagnose you and is not attempting to replace a doctor. Instead we are using mathematics to simulate the thought process of the doctor in order to provide you with information appropriate to your symptoms. Diagnosis requires testing, physical examination and observation.
Always consult with your doctor or other appropriate health professional before relying or making health or well-being decisions based on information provided.

Research suggests Healthily offers appropriate “next steps/triage” recommendations between 92% to 98% of the time. The independent studies this statement is based on have been conducted by Imperial College, London can be found [here](https://drive.google.com/file/d/1e5sT5s2rnDp6Vwgq3_s3izfY48Mb5F_T/view?usp=sharing) and the Brown University, USA, study can be found [here](https://drive.google.com/file/d/1D6wFGmKcWjrwgBXRvDf8SyVmoh6Mo9O-/view?usp=sharing).

Healthily has reached this standard by implementing rigorous clinical safety protocols, aligned with NHS safety standards, overseen by [Professor Maureen Baker, CBE](https://www.linkedin.com/in/maureen-baker-cbe-9a2b421/) FRCGP, Healthily’s Chief Medical Officer - who led the creation of the UK NHS’s digital safety standards.

Maureen is supported by [Stuart Harrison](https://www.linkedin.com/in/stuart-harrison-beng-hons-ceng-fiet-254b9a13/), Healthily’s independent clinical safety auditor and NHS Digital’s former Head of Safety Engineering.

The interests of our users are safeguarded by our Clinical Advisory Board. Information about its members can be found [here](https://www.your.md/blog/meet-your-mds-advisory-board).

This team of senior executives, independent advisors and practicing clinicians has supported Healthily to recive from the UK’s [Medicines Healthcare products Regulatory Authority (MHRA)](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency) a class I Medical Device certificate, meaning that our app complies with the European Union’s (EU)  Medical Device Directive and the EU’s new Medical Device Regulation (2020).

As part of this classification Healthily confirms it conforms to the recommendations of the following international standards:

- DCB0129 - Clinical Risk Management
- IS0 13845 (2016) - Medical devices - quality management systems - requirements for regulatory purposes
- ISO 14971 (2019) - Medical devices - application of risk management to medical devices

At its heart Healthily has a clinical safety management process which every employee is trained in and a safety incident reporting process. If you have any concerns about safety while using the app please contact us at [support@livehealthily.com](mailto:support@livehealthily).

Underpinning our standards and safety  approach is the rigorous documentation of our clinical source material. We have created a medical database that holds all the information used by our augmented intelligence and where the information was sourced from. This process is subject to regular audit and refinement.

The primary sources we use to inform our AI are:

- [BMJ Best Practice](https://bestpractice.bmj.com/info/)
- [Uptodate](https://www.uptodate.com/home)
- [NICE Clinical Knowledge Summaries](https://cks.nice.org.uk)
- [Dynamed](https://www.dynamed.com/home)
- Guidelines of international societies i.e. [World Health Organisation](https://www.who.int/publications/guidelines/en/)
- Reputable peer reviewed publications e.g. [JAMA](https://jamanetwork.com), [BMJ](https://www.bmj.com)

## Example methodology

Using this methodology a typical condition citation list looks like this:

__Condition name: Acute coronary syndrome__
*Source list for Symptoms:*

1. [Uptodate - Diagnosis of acute myocardial infarction](https://www.uptodate.com/contents/diagnosis-of-acute-myocardial-infarction?search=myocardial%20infarction&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2#H8)

2. [BMJ Best Practice - History exam](https://bestpractice.bmj.com/topics/en-us/150/history-exam)

3. [Patient UK - Acute Coronary Syndrome](https://patient.info/doctor/acute-coronary-syndrome-pro)

4. [E-medicine](https://emedicine.medscape.com/article/155919-clinical)

5. [Dynamed](https://www.dynamed.com/condition/st-elevation-myocardial-infarction-stemi#GUID-364DBE99-DB27-43E8-91DC-A2BBB07692B6)

6. [BMJ paper](https://bmjopen.bmj.com/content/9/2/e027081)

7. [NICE CKS](https://cks.nice.org.uk/chest-pain#!diagnosisAdditional)

8. JAMA - *Ferry, Amy V et al. “Presenting Symptoms in Men and Women Diagnosed With Myocardial Infarction Using Sex-Specific Criteria.” Journal of the American Heart Association vol. 8,17 (2019): e012307. doi:10.1161/JAHA.119.012307*

The majority of our medical content is supplied and indemnified by the UK’s NHS. It is checked by two practicing and written under the principles of the NHS Information Standard. Healthily’s own medical content follows the same standard and approach and is checked by at least two practicing doctors. 

For more information about our medical team and content team take a look at their biographies [here](https://www.your.md/blog/our-editorial-medical-team).

For more information about our editorial standards, policies and principles please see our guidelines [here](https://www.your.md/legal/editorial-policy-principles).

Healthily also has a quality management system that has been independently audited by [Professional Records Standards Body (PRSB)](https://theprsb.org). The PRSB has conducted an audit of all our internal processes to assess the safety of our operations. The report is available [here](https://drive.google.com/file/d/1ZDt8Vg7WNcVPTvJM460uJ4zrJSgDHSAU/view?usp=sharing).

ORCHA is an independent reviewer of medical apps working with the UK National Health Service. Our app was reviewed and achieved ORCHA’s app Quality Mark with a score of 76% (Level 4 - the highest). The ORCHA App review process is outlined [here](https://www.orcha.co.uk/our-solution/the-orcha-review/).

Our App has also received the [ePrivacyseal](https://www.eprivacy.eu/en/customers/awarded-seals/company/yourmd-ltd/) data protection seal of approval following an in-depth audit. The ePrivacyseal attests to a product’s compliance with the list of ePrivacyseal criteria, which reflects the security requirements imposed by EU data protection legislation in accordance to EU General Data protection Regulation.

We also follow the principles set out by the [NHS Information Standard](https://www.england.nhs.uk/tis/) for the creation of content.

We hope this information is helpful and reassures you that we are taking your safety seriously.

Thank you for using Healthily. See you soon.

At Healthily your safety is our primary concern. We’ve invested a great deal of time and resources to ensure that our products and services are medically assured and safe.