This appeared a few days ago:
Mobile messaging platforms: the clinical and regulatory risks explored
It is known that during the pandemic, mainstream consumer messaging apps were used by clinicians in order to manage very high activity levels, but what happens when Covid-19 related activity levels subside? A recent Digital Health webinar looked into the clinical and regulatory risks of mobile messaging platforms.
DHI News Team – 29 July 2021
Mobile messaging systems are a vital tool to enable busy clinicians to manage heavy caseloads, but there is increasing concern about the clinical and regulatory risk to which some systems can expose users and their employers. A recent Digital Health webinar explored this topic and found that more than half of the 130 or so participants were concerned that the messaging platform they used for clinical work did not comply with GDPR. In addition, more than a third of participants were worried that decisions made using their messaging system did not link to their organisation’s electronic patient record (EPR).
These concerns about regulatory and clinical governance compliance are likely to be well-founded. Solicitor Darryn Hale, a senior associate specialising in health information law at DAC Beachcroft, told the webinar that use of generic messaging applications like WhatsApp to discuss patients’ clinical treatment would be unlikely to meet all legal and regulatory requirements.
Regardless of what it was designed for, any software or system being used to help decide patient care is likely to be regarded as a diagnostic medical device and therefore has to meet standards set by the Medicines and Healthcare products Regulatory Agency.
As a result, he said, “it has to be the case that using non-regulated devices is a clear risk for an organisation”.
“If data were to be lost or if there was a suggestion in a clinical negligence claim that information was shared inappropriately or didn’t get to the right place, the fact that you have used a non-regulated piece of software in support of diagnostic decisions could be an additional risk; it could be an aggravating factor,” he added.
“If you’re using something which has not received appropriate regulatory approval then you open yourself up to the risk of enforcement action by the Information Commissioner’s Office, or other forms of claims, exacerbating the liability you are exposed to.”
Using personal accounts for clinical care
He also warned that regulations enforced by the Care Quality Commission (CQC) require that there is an “accurate, complete and contemporaneous” in respect of each , and so if key decisions and episodes of care were not stored in the electronic patient record – because they had been taken using a messaging system that does not link to the Electronic Patient Record – then that record is arguably not complete and accurate, putting a trust at risk of action from the regulator.
He added that there are a number of aspects of the UK General Data Protection Regulation that are likely to be difficult to meet if trusts allow individual clinicians to use personal messaging accounts for clinical care purposes, particularly in respect of data security and mandatory contractual governance.
More here:
Just as in the UK I am sure the use of mobile messaging has sky rocketed as the demands of the pandemic increased. With a little breather we now need to make sure we have not slipped into the use of things like WhatsApp without carefully considering the implications.
The summary paragraph says it all:
“Overall, the webinar highlighted how many of the most high-profile systems fell woefully short across important areas. It also clearly underlined the need for safe, secure and compliant clinical messaging platforms, which clinicians need, want and expect to use in the course of their work.”
Comments welcome of good and bad practice you have seen in this domain!
David.
1 comment:
The same issue that was being called out ten plus years ago. The need is was for clinical messaging, we got PcEHR/MyHR. We lost the good and retained to stubborn and ignorant as evident through ADHA webinars, product briefings and relics of that era.
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