Governance

NHS Apps Library

The ORCHA Baseline Review (‘OBR’) is ORCHA’s first level of assessment and involves a detailed ‘desktop’ analysis of Digital Health solutions looking across all of the key areas of regulation and compliance. The OBR is largely undertaken proactively as part of ORCHA’s ongoing assessment and monitoring of the whole Digital Health market place and we review the most downloaded and most recently updated Apps and related Digital Health solutions across over 250 health and care categories and conditions.

What is DTAC

The Digital Technology Assessment Criteria for health and social care (DTAC) gives staff, patients and citizens confidence that the digital health tools they use meet our clinical safety, data protection, technical security, interoperability and usability and accessibility standards.The DTAC brings together legislation and good practice in these areas. It is the new national baseline criteria for digital health technologies entering into the NHS and social care.The DTAC is designed to be used by healthcare organisations to assess suppliers at the point of procurement or as part of a due diligence process, to make sure new digital technologies meet our minimum baseline standards. For developers, it sets out what is expected for entry into the NHS and social care.

Clinical Safety Case Standards

Our understanding is that the Clinical Safety Case standards do not apply to the EP mobile application or eCare platform.

Indeed, these standards are a set of requirements to ensure the effective application of clinical risk management by those organisations that are responsible for the development and maintenance of ‘Health IT Systems’ for use within the health and care environment. Health IT Systems are products used to provide electronic information for health or social care purposes. The scope of these standards includes the provision of health services, NHS services or adult social care.

It comprehends:

• all clinical functionality which could potentially cause harm to patients
• operational use and potential misuse of the clinical functionality and its potential to cause harm to patients
• all Health IT Systems including those that are also controlled by medical devices regulations. Medical devices include any instrument, appliance, software, implant, reagent, material intended by the manufacturer to be used for human beings for diagnosis, prevention, monitoring, treatment of disease, injury or disability.

The overall purpose is to make sure that manufacturers of such Health IT System do not compromise patient safety and to reduce the existing clinical risk.

In the setting of EP’s operations, the App is to be used for informational purposes only and does not provide healthcare services. Its Terms of Use state that the information on the App does not constitute professional medical advice, diagnosis or treatment. On the other hand, the eCare platform provides a content library of resources delivered virtually and allows health practitioners to send parenting advice via email.

EP solutions are not meant to be used as medical devices but offer quality expert information. Therefore, the platform itself does not intend to serve any medical purposes.

As a result, our interpretation is that these standards don’t apply. Disclaimers are in place to make clear that the information provided is not a medical opinion. Access to eCare is granted by the health team of the parents.

With regards to the parents’ digital records, we assume they would be integrated for the parents and the health practitioners to access it more easily and have all their information in one place. It would not change the purpose of EP solutions. In such a case, the scenario stays the same and the standards do not apply.