Newfoundland & Labrador and ORCHA Health Ltd. Terms of Service
Intellectual Property
All text, graphics, user interfaces, visual interfaces, photographs, trademarks, logos, sounds, music, artwork and computer code (collectively, “Content”), including but not limited to the design, structure, selection, coordination, expression, “look and feel” and arrangement of such Content, contained on the Site is owned, controlled or licensed by or to Newfoundland & Labrador, Mental Health Commission of Canada (MHCC) a national non-profit organization created by the Canadian government, and ORCHA Healthcare Ltd (ORCHA), a company registered in England, and is protected by trade dress, copyright, patent and trademark laws, and various other intellectual property rights and unfair competition laws.
Except as expressly provided in these Terms of Use, no part of the Site and no Content may be copied, reproduced, republished, uploaded, posted, publicly displayed, encoded, translated, transmitted or distributed in any way (including “mirroring”) to any other computer, server, Web site or other medium for publication or distribution or for any commercial enterprise, without Newfoundland & Labrador and ORCHA express prior written consent.
Any extracts from the website that are reproduced for non-commercial purposes should be supported by a full acknowledgement and reference to Newfoundland & Labrador and ORCHA.
The publishing of hyperlinks to external websites is for information and reference purposes. It does not imply any Approval of their contents or commercial affiliation. Newfoundland & Labrador and ORCHA are not responsible for the accuracy, timeliness or relevance of such linked websites.
The MHCC Assessment and Service
The assessment process for the Mental Health Commission of Canada’s Assessment Framework for Mental Health Apps begins with the Organization for the Review of Care and Health Apps (ORCHA) Baseline Review (OBR). As the OBR is based only on publicly available empirical and non-empirical evidence, this can take place without any interaction with the developer unless specific access details or demo data are required. The OBR is carried out by the assessment team, using ORCHA’s Review Engine. The ORCHA review engine is a web-based application that facilitates assessors in carrying out the dynamic and responsive assessments of apps. This is a crucial tool that automates the assessment workflow, queues apps, allows assessors to input answers and manages the complex scoring mechanism and decision process. In conclusion, the ORCHA Review Engine fuses human expert analysis with technological and data driven integration methods.
Once the OBR has taken place, the assessor can then carry out the MHCC Assessment which requires the developer to upload evidence via SharePoint. ORCHA provides the developer with guidance surrounding exactly what they are required to submit. Examples of the evidence a developer may be asked to submit include: a penetration test, risk management documentation, user acceptance testing, and evidence to demonstrate compliance with EGAP and OCAP if race-based/ethnicity and/or Indigenous-identity data is collected.
Once the developer has submitted the evidence for their mental health intervention, answers to any criteria that overlap between the OBR and MHCC Assessment Framework are automatically imported into the MHCC Assessment to save duplication. An assessor will then use a combination of the developer submission, and publicly available information, to assess against the remaining MHCC criteria. Each assessment is initially assessed by one assessor, and then checked or 'signed off' by a second assessor before it is completed. If the application reaches the minimum 'pass' threshold for the MHCC Assessment Framework, it will surface on the Compliance Portal. The MHCC Assessment is primarily an assessment of an Apps compliance with current standards, regulation and good practice (together 'Standards').
A standard is an agreed way of doing something. It could be about making a product, managing a process, delivering a service or supplying materials – standards can cover a huge range of activities undertaken by organizations and used by their customers.
'Standards are the distilled wisdom of people with expertise in their subject matter and who know the needs of the organizations they represent – people such as manufacturers, sellers, buyers, customers, trade associations, users or regulators.' (British Standards Institute)
They can be of regulatory significance or form non regulatory requirements or required best practice in a given jurisdiction or area.
The Standards we currently look at in the MHCC Assessment are:
Data
The Personal Information Protection and Electronic Documents Act (PIPEDA)
The Personal Information Protection Act (PIPA)
The Freedom of Information and Protection of Privacy Act (FIPPA)
Quebec's Privacy Act
DD ISO TS 25237, Health informatics – Pseudonymization
GSMA: Privacy Design Guidelines for Mobile Application Development.
GSMA: Mobile & Privacy Guideline TCC2, TCC3, DRS4
AQUA: Best Practice Guidelines for producing high quality mobile applications version 2.3 – June 2013
Technical Stability & Security
CyberSecure Canada
CIS Critical Security Controls Top 20
System and Organization Controls (SOC)-2
ISO 27001 - Information security management Systems
Clinical Evidence and Safety
BS EN ISO 14971, Medical devices – Application of risk management to medical devices
Medical Device Regulations (SOR/98-282)
CAN/CSA ISO 13485:2003 Medical devices - Quality management systems
PAS 277:2015: Health and wellness apps – Quality criteria across the life cycle – Code of practice and the Medical Devices Directive
NICE Evidence Standards Framework (ESF) for digital health technologies
User Experience
APP QUALITY ALLIANCE: Accessibility Testing Criteria for Android Applications version 1.2: July 2015
AQUA BEST PRACTICE GUIDANCE 2015
Apple Human Interface Guidelines (HIG). Available at https://developer.apple.com/app-store/review/guidelines/ Google’s Android App Quality Guidelines. Available at: https://play.google.com/about/developer-content-policy/
W3C guidance. Available at: https://www.w3.org/WAI/intro/usable
WCAG 2.0 AA and WCAG 2.1 AA Guidelines
ISO 9241-210: Human-centred design for interactive systems
mHealth Application Usability Questionnaire (MAUQ)
Americans with Disabilities Act (ADA)
Accessibility for Ontarians with Disabilities Act (AODA)
ISO 25062: Software product Quality Requirements and Evaluation (SQuaRE) — Common Industry Format (CIF) for usability test reports
Cultural Safety, Social Responsibility, and Equity Standards
The Cultural Safety, Social Responsibility and Equity Standards address the representation and inclusivity within the application, particularly for minority communities, incorporating
UN Convention on the Rights of Persons with Disabilities
Language that is aligned with recovery principles
Ownership, Control, Access and Possession (OCAP) for DHTs likely to be used by Indigenous populations.
Enhanced Data Sovereignty
Engagement, Governance, Access and Protection (EGAP)
Ownership, Control, Access, Protection (OCAP)
Guidance on the Use of Standards for Race-Based and Indigenous Identity Data Collection and Health Reporting in Canada (Canadian Institute for Health Information (CIHI))
The MHCC Assessment seeks to assess an Apps performance through its compliance with these Standards. Our Review is regularly updated to reflect changes in these Standards. The higher the MHCC Assessment Score achieved the more compliant the App is with these Standards and vice versa.
While a high scoring app is not guaranteed to be effective or safe, or a poorly scoring app is not necessarily ineffective or unsafe, it does mean that the relevant Developer has taken more or less care over the apps compliance with these key Standards than other similar apps. In the critical area of healthcare, we believe that developers should take compliance with Standards extremely seriously.
Some apps are technically medical devices and would require registration with Medical Devices Establishment License (MDEL) Listing for class I devices, or Medical Devices Active License Listing (MDALL) for class II – class IV devices . Apps of this nature should not be made available to the general public until they have been assessed and appropriately registered/licensed and any apps that we identify as being an unregistered/unlicensed medical device is excluded from our general search.
If you become aware of any inaccuracy in the information presented in our Reviews or have any other concerns, please report this to us immediately at hello@orchahealth.com. MHCC and ORCHA are not promoting or recommending any particular apps through this process but are providing impartial information about an apps compliance with standards and a mechanism for end users to easily identify those Apps that best meet those Standards and to check which ones don’t.
Inaccurate or misleading information
MHCC Assessments are based on the information provided by app developers the app itself and/or available in the public domain via a connected website or the relevant ‘app store’. We are reliant on this information in undertaking our reviews and are not responsible for inaccuracies or errors in the information provided. App Developers are governed in most jurisdictions by laws that require them not to make misleading or inaccurate statements about their products and if you believe that any information provided via our reviews is inaccurate or misleading, please contact us at hello@orchahealth.com and we will immediately investigate this.
Even where the information provided is accurate, our review cannot guarantee that an app will perform as promised in any specific circumstances or that the app is free now or in the future from any bugs or issues that might affect its performance. We accept no responsibility for any adverse effects of the app or Digital Health solution in question.
Data & Privacy
All data is held in accordance with the terms of the Personal Information Protection and Electronic Documents Act (PIPEDA)and all associated national and provincial Data Protection laws within Canada.
All the purposes and the legitimate bases, for ORCHA data collection is laid out within our Privacy Policy and no personal data is collected or processed without the user consent, which is an opt-in model, or outside of the legitimate bases upon which we have described. How we use data, the nature of the data we collect and our policies around retention and portability can all be found via the ORCHA Privacy Policy.
Medical/Professional Care and Advice
The content on our website is not intended to be a substitute for professional medical care by a qualified doctor or other suitable healthcare professional (“Professional“). You should always check with your Professional if you have any concerns about your health, your condition or any treatment you may be taking or planning to take. If you receive an App Recommendation from a Professional via an ORCHA powered platform, the Recommendation is being made based on that Professionals judgement about the suitability of an App for your specific needs and the information provided by MHCC and ORCHA upon which the Professional is relying upon. The MHCC Assessment and Score is in turn reliant on the accuracy of the information provided by the App Developer themselves.
Neither the Professional, MHCC or ORCHA are responsible for inaccuracies or errors in that information. Even where the information provided is accurate, the MHCC Assessment cannot guarantee that an App will perform as promised in any specific circumstances or that the app is free now or in the future from any bugs or issues that might affect its performance and neither the Professional, MHCC nor ORCHA can be held responsible for issues arising in these circumstances.
If you are a healthcare professional, this website is intended to support and enhance, but not to replace your own judgment and knowledge.
General
You may not use this website for unlawful purposes, in any way that breaches Applicable law or regulation. You may not use our content fraudulently or for the purposes of generating unsolicited spam emails or computer viruses.
These Terms and Conditions are governed by Canadian law. We reserve the right to change our Terms and Conditions at any time, as they are updated to meet changing needs and any new legislation.