Press Release

Digital health technology company ‘bares all’ to standards body to help assure quality and safety

19 October 2020

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October 19, 2020 - Global self-care platform Healthily has joined forces with the UK standard setter for health and social care records to develop a new methodology for assessing the way digital providers manage personal health data safely.

Your.MD - the creators of Healthily - approached the Professional Record Standards Body (PRSB) earlier this year to help ensure that the rapid growth of the business was not compromising the safety of their users. PRSB helps define the standards needed for good care records including in digital care.

Former chief executive at the NHS Institute for Innovation and Improvement and a leading advisor to the PRSB, Professor Bernard Crump, agreed to take on the challenge. He recognised that the benefits of the project lay beyond Healthily and extended to other digital platforms. The findings have just been published.

Your.MD commissioned the review as part of their commitment to assuring quality and safety in the fast-moving and fragmented digital health technology landscape.

Commenting on the project, CEO and co-founder of Your.MD, Matteo Berlucchi, said:

“For too long, multiple agencies — all with different standards and perspectives — have taken a back seat when it comes to interrogating the safety, quality and culture of emerging digital healthcare.

“At Your.MD, we have always put quality and safety first, so we decided to put our money where our mouth is and ask the experts to take a look.”

Professor Crump added, “PRSB members understand the rapid increase in the potential use of digital apps in health and social care. They also know that end users can find this arena confusing in terms of what they can rely on and how much faith they can place in what’s offered.

“Working with Your.MD and Healthily gave us an opportunity to think about what framework could be useful in addressing these questions and then try it out in a real-world situation.”

Professor Crump and the consultancy team from the PRSB are very encouraged by the results.

“We were looking at Healthily’s quality management system (QMS) – a series of policies, procedures and mechanisms, which included security of data, handling of confidentiality, how the system responds to new guidance that might emerge and the process for handling the updating process.”

As part of the review, Professor Crump’s team constructed a number of scenarios that might arise: “For instance, if the organisation were approached with concerns about any aspect of the app, what would be the process to handle that and decide what its appropriate course of action might be?”

“We could see the organisation was growing rapidly in terms of its scope and user base. We thought it was appropriate for them to reflect through our report on where they were in that journey and the additional features they wanted to include.

“We encouraged Your.MD to look at introducing some greater formality in some aspects of the way they operated, in order to reflect the fact that it was now a significantly larger organisation than it had been a year before.

“It’s to the organisation’s credit that it’s collaborating with organisations to help reflect on the quality of work that it does. The review should be deemed as successful for both parties.”

The review found Your.MD to be in a strong position with respect to quality and safety for a digital health technology company. In particular, Healthily was found to be compliant in 96% of the applicable standards laid out in DCB 0129 Clinical Risk Management: its Application in the Manufacture of Health IT Systems.

PRSB concluded that the establishment of the Your.MD clinical advisory board, the commissioning of the review itself, the commissioning of external academic work to examine the validity of the symptom checker, the high calibre of those appointed to senior roles, and the adoption of a new and improved QMS were all testament to an organisation wanting to develop and look critically at its role.

Your.MD will now be looking at the recommendations and delivering on the findings before inviting the PRSB back for a follow-up review.

ENDS

Contact: Helen Mooney, ZPB Associates: helen.mooney@zpb-associates.com, 07849 089456
Notes to editors

Review Findings

The review findings present an overall good position with respect to quality and safety for a digital health technology company. This means that there has been overall compliance to the standards originally agreed within scope. Implementation of report recommendations should lead to comprehensive compliance, which will be assured by an annual review.

Key Recommendations:
A process or standard operating procedure (SOP) to encompass third party assessment, that includes commercial onboarding arrangements or agreements should be considered. This is specifically aimed at those third-party systems or services that fall within scope of the clinical safety standards
The clinical advisory board should be given ultimate responsibility for clinical safety and should no longer be considered as ‘advisory’
The organisation should consider a more systematic corporate management of risk, and a transition of governance to that of a mature, established organisation
The organisation should introduce the role of a person responsible for regulatory compliance
Once the QMS is embedded, a subsequent review should assess whether this comprehensively meets the management of quality and clinical safety within the organisation, evidenced by how challenges have been met

About Your.MD and Healthily
Healthily is a digital health platform committed to helping everyone in the world find their health through informed self-care, bringing together the tools you need to look after your all-round health. Your.MD is the creator of Healthily, a free app that helps you assess, learn, track, discuss, find and manage your way to better health.
The only self-care app registered as a Class 1 Medical Device, Healthily aims to help a billion people find their health through informed self-care.
Healthily platform tools:
ASSESS: Our friendly chatbot helps you decide if you need to see a doctor. Tell it how you feel and its Augmented Intelligence recommends the best next steps for your symptoms – including self-care for issues you can treat at home.
LEARN: Our Health Library, sourced from the UK’s National Health Service, completed by our own medical team, is the simplest, safest and most comprehensive in the world. Includes the up-to-date guidance and information on coronavirus (COVID-19).
TRACK: Our user-friendly, secure health journal and symptom trackers help you keep track of your health and store notes, in complete privacy.
FIND: We’ve created OneStop Health™ Marketplace, the first vetted directory of health-related products and services offered by other companies. So you can speak to a doctor, find a medicine or discover the best apps for you.
MANAGE: We’re also building self-care hubs to help you manage and improve specific health areas or conditions. Our first 2 hubs, on sleep and general wellbeing, put together by our medical team, are completely free.

About Bernard Crump
Professor Crump is currently an advisor to the Professional Record Standards Body. Before that, he practised clinical medicine and clinical research before specialist training in Public Health. He was a director of public health for more than a decade before being appointed chief executive of a strategic health authority and the NHS Institute for Innovation and Improvement.

About the PRSB
The Professional Records Standards Body aims to produce better records for better care. PRSB develops standards for the content of digital health and care records and promotes their use so that information can be shared whenever and wherever it is needed to ensure people can always receive safe, effective care.
PRSB represents a membership of over 2.5m medical professionals, as well as royal colleges, patient organisations and social care organisations. https://theprsb.org/

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