About
The OBR (ORCHA Baseline Review)
The OBR 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 OBR are:
- CQC – Care Quality Commission
The independent regulator of all health and social care services in England. If an App provides a health service to the user, it may need to be registered with the CQC. - Caldicott Principles
We assess whether Apps comply with the NHS Data Standards. The Caldicott Principles ensure that any patient information which could identify them is protected, and is only used and shared when it is appropriate to do so.
The Review Process
ORCHA is one of the leading providers of Health and Care App evaluations and reviews.
It provides an objective and independent assessment of health and medical Apps. This is an advisory not regulatory service, but we do advise whereregulatory issues may be important and should be consideredfurther. It is however ultimately the responsibility of thedevelopers and/or publishers of an App to ascertain itscompliance with all relevant regulatory standards.The ORCHABaseline Review ('OBR') is ORCHA's first level of assessment andinvolves a detailed 'desktop' analysis of Digital Healthsolutions looking across all of the key areas of regulation andcompliance. The OBR is largely undertaken proactively as part ofORCHA's ongoing assessment and monitoring of the whole DigitalHealth market place and we review the most downloaded and mostrecently updated Apps and related Digital Health solutionsacross over 250 health and care categories and conditions.
Scoring
The OBR seeks to assess an App`s performance through its compliance with these Standards. Our Review is regularly updated to reflect changes in these Standards. The higher the ORCHA Score achieved the more compliant the App is with these Standards and vice versa.
Whilst 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 health and care, we believe that developers should take compliance with Standards extremely seriously.
Some Apps are technically medical devices and for class iia, iib and iii devices, require full assessment and Approval in the EU through processes overseen by the national regulatory bodies such as the MHRA in the UK and HPRA in Ireland and in other jurisdictions by similar regulatory bodies. An App of this nature should not be made available to the general public until it has been assessed and appropriately certified and any that we identify as being a non uncertified medical device is excluded from our general search.