Regulatory Requirements

Revised 2022-12-16

MEDICAL DEVICE STATUS OF THE API

The API is a medical device class I on the EU and UK markets and can therefore be integrated only with services that constitute class I medical device (if any) and not higher. The developer needs to consider regulatory requirements of the Licensee API Service, namely the Developer Service with the API integrated and ensure compliance. The API is not a medical device on the US market. Healthily is not a HIPAA covered entity. The Developer is obligated to inform Healthily in case the Developer is a HIPAA covered entity.

HEALTHILY CERTIFICATIONS

CE Mark Version 1.0, Date of Manufacture 2/04/18, Manufacture contact details
Your.MD Ltd, 167-169 Great Portland Street 5th Floor, London, England, United Kingdom, W1W 5PF [email protected]

Use: This App (Healthily Services) is intended for use via a website, an App for the Android and iOS smartphone platforms, web-based application (Web App). Components of this service enable the following functionalities ‘Symptom Checker’ and ‘Health Library’.

Warnings: Please read before starting to use our services
Your.MD Services are designed and intended to be used as an adjunct to the diagnostic and/or triaging process of a doctor and does not provide diagnoses, medical advice or treatment. Our Services cannot be used for information about babies, children under the age of 16, pregnant women, people on immunosuppressive treatment and people with long term conditions.

Please see the Developer Licence Agreement and our Safe Use Instructions for further information.
ePrivacyApp
https://www.eprivacy.eu/en/customers/awarded-seals/company/yourmd-ltd
Healthily
Version: 4.03.15 iOS and 4.03.13 Android
Validity: 03.06.2022 - 02.06.2023

COMPLIANCE

Healthily is responsible for regulatory compliance of the API only as a standalone service according to the intended use, as described below. The Developer acknowledges that embedding the API to its service creates a new product or service, namely the Licensee API Service. The Developer is obligated to consider regulatory requirements of such new product or service and ensure regulatory compliance relating to medical devices regulation, data processing regulation, consumer protection regulation as well any other applicable legislation depending on the nature of the new product or service on the applicable territory. The Developer is solely responsible for the new service/product created by embedding the Healthily API to its service, including but not limited to the regulatory compliance and any accompanying end user relationships, namely, to implement and/or acquire any necessary permits, certifications, and approvals applicable for such new service/product (for example medical device certification, end user consents for the data processing, exercising end users’ legislative rights etc.).

INTENDED USE OF THE API

The Developer acknowledges that Healthily API is not a diagnostic tool, and the consultation outcome/report does not constitute a diagnosis, medical advice, or treatment recommendation.
The fundamental aim of the Healthily API is to support a user to decide if there is a need to see a healthcare professional. It is intended to add supplemental information to help the user make an informed decision about his health by providing:

medically safe information about the most probable condition/s that match self-reported symptoms and reported health data (‘’possible causes’’);
a summary with safety message for the red flag symptom/s - namely any symptom, or symptom combination that could indicate a serious underlying condition, along with the list of possible conditions (‘’summary’’);
short information on each of the most likely conditions.

The possible cause or causes is/are the most probable condition/s that match the self-reported symptoms without considering any other circumstances that a real doctor can consider. The safety summary message is based on both the most concerning condition and the most concerning symptom or combination of symptoms which could indicate a serious underlying condition, even when the probability of such a condition is less likely than the possible cause/s.
Possible causes don’t mean that the end user has that condition or that it doesn’t have any other serious condition which Healthily API wasn’t able to identify. Healthily API isn't a real-life doctor, which means it can't: a) consider all the information a doctor can when interacting with the end user; b) identify every possible condition or symptom the user might have; c) always understand the information provided by the user. Users should therefore be always instructed to visit a doctor if they’re in doubt, their symptoms get worse or don’t improve.

Healthily API can only be used by users who are generally healthy and don’t have any ongoing or rare medical conditions. Healthily API can’t be used to get information about babies, children under the age of 16, pregnant women, people who are immunosuppressed or on immunosuppressive treatment, and people with complex or long-term conditions.

REGULATORY SUGGESTIONS

These regulatory suggestions are merely the guidelines for the regulatory compliance of the API as a standalone service and do not consider embedding the API to the Developer’s service and creating a new service, the Licensee API Service. The Developer should therefore not rely on the regulatory information provided herein alone and should always seek an opinion of a regulatory compliance expert to ensure compliance of the Licensee API Service. The Developer is obligated to ensure safe use of the Healthily API and therefore needs to inform the end users about the limitations of the Healthily API as stated in this section Regulatory Compliance. The Developer is not allowed to mislead the end users into thinking that the Healthily API provides diagnosis and should refrain from using unclear or misleading language or graphical presentations that imply diagnosis. The Developer is not allowed to use the word ‘’diagnosis’’ when using the API. The Developer is advised to use the exact wordings and graphical presentations (sequence of the information provided, page split etc.) as provided with the API to avoid any misrepresentation of the API’s intended use. The Developer is obligated to ensure clear separation of the information shown on the consultation report screen and on the next steps screen, these two screens should not be merged. The Developer is obligated to ensure that each end user actively accepts the disclaimer below before the consultation outcome is shown:

‘’We will analyse the information you have given us and show you a summary of the suggested next steps. Please note, this is not a diagnosis. Always visit a doctor if you are in doubt, or if your symptoms get worse or don’t improve. If your situation is serious, always call the emergency services. We are not liable for any decisions, acts or omissions you make. Please see how to use our services safely: link to safe use instructions for the Licensee API Service to be added’’
The Developer is obligated to add the disclaimer below to each consultation report:

‘’This is not a diagnosis, medical advice or treatment recommendation. The suggested next steps are based on a group of people with similar characteristic such as your age, sex and health background, who are generally healthy and don’t suffer from any chronic or rare medical conditions. We can’t consider all the information a doctor can, and we are not liable to identify all possible conditions or symptoms.’’

The developer is obligated to inform end users about the instructions for the safe use of the API, namely https://www.livehealthily.com/legal/safe-use in a clear and transparent manner.

DATA PROCESSING

By embedding the Healthily API Healthily will process the data that may qualify as personal data and health data relating to the end users of the Licensee API Service, namely the Developer Service with the API integrated. Healthily is the data processor and or service provider and the Developer is the data controller in relation to the processing of any data that is processed through the API (‘’Developer’s Data’’), including but not limited to personal and health data from the end users of the Licensee API Service.

The Developer is solely responsible for the lawfulness of the processing of the Developer Data and shall be required to store any data processed through the API in order to ensure regulatory compliance on the territory. The Developer is therefore obligated to ensure that each end user actively consents to the data processing done by Healthily before any data is shared with the API. This includes obtaining any end user consent the Developer is legally or contractually required to obtain from its end users also including Healthily data processing as well as ensuring the exercise of any other legislative rights (for example data retention, GDPR requests, UK Data Protection Act 2018 requests or any similar legislation on the applicable territory etc.). Healthily will process the Developer’s Data solely for the purpose of offering the API to the Developer and for internal analytics on aggregate level. Healthily and the Developer will enter into a Data processing Agreement ADD A LINK before any data is shared with the API.

LIMITATIONS ON LICENCE

The Developer Licence agreement includes an extensive list of limitations on licence that the Developer should adhere to. Here are just a few examples:

The Developer can integrate the API to its service as determined in the Developer Licence agreement, however it is not allowed to amend the API or Healthily Service in any way or use the API outside the Authorised Purpose as determined in the Developer Licence agreement. Licensee needs to acquire Licensor’s written consent in case it wants to use the API for any new service, product or technology and before it makes any material changes to the Licensee Service.
Licensee shall have no right to amend, distribute, licence (through multiple tiers or otherwise), sublicense or otherwise transfer the API, API Key or related documentation to any third party or incorporate the API into any (existing or new) software, product, service or technology that is not part of the Developer Licence agreement.
Implementation of features found in the chat API (for example Health Tests, BMI etc,) outside of the chat process is strictly forbidden.
Licensee is not allowed to integrate the API in case Licensee Service has a status of a medical device higher than class I.Licensor reserves the right to limit the number of calls to the API in order to prevent damage to its Service and terminate access at any time.
The Developer can offer the API solely to consumers, so non-commercial end users who sign up for the Licensee API Service, namely the Developer Service with the API integrated.
The use of the API by the Developer should always be white labelled.
The Developer should not use the API to create and/or offer a product or service similar to the Healthily Service either by itself or through a third party.
The Developer should not integrate the API with its service if this creates an uncompliant product or service and/or if the use of the API by the Developer constitutes a breach of the applicable legislation and/or creates a service that is not compliant with valid legislation.
The Developer should not integrate the API to its service if this constitutes a breach of any third party right.
The Developer shall not make any representations or public communication about Healthily or the API without Healthily’s prior written consent.