While your humble correspondent continues to delight in the emerging science of “mHealth” as a newly minted start-up Chief Medical Officer, he ran across this interesting article on risk and patient safety.
Authors Thomas Lewis and Jeremy Wyatt worry that “apps” can lead to patient harm.
They posit that the likelihood of harm is mainly a function of 1) the nature of the mistake itself (miscalculating a body mass index is far less problematic than miscalculating a drug dose) and 2) its severity (overdosing on a cupcake versus a narcotic). When you include other “inherent and external variables,” including the display, the user interface, network issues, information storage, informational complexity and the number of patients using it, the risks can grow from a simple case of developer embarrassment to catastrophic patient loss of life.
In response, they propose that app developers think about this “two dimensional app space” that relies on a risk assessment coupled to a staggered regulation model. That regulation can range from simple clinical self assessment to a more complex and formal approval process.
What’s clear to your correspondent is that hidebound mainframe entities like the Food and Drug Administration are no match for the app “ecosystem“. Rather than try to formulate a one-size-fits-all “not function as intended” model like this, maybe it should triage its oversight using the Lewis and Wyatt framework.
In addition, I agree with Lewis and Wyatt that safety is also a function of clinician input. Docs and nurses can assess possible mistakes, their downside severity and the impact of all those variables.
I couldn’t have put it better myself:
“…. many app developers have little or no formal medical training and do not involve clinicians in the development process and may therefore be unaware of patient safety issues raised by inappropriate app content or functioning.”
Without the insights of seasoned real-world doctors and nurses, apps could end up with the same safety issues that are plaguing electronic health records, many of which were also developed with little regard to physician or nurse input.
In other words, just because it’s a “health” app doesn’t mean its necessarily so.
Jaan Sidorov is Chief Medical Officer at MedSolis.
Categories: Uncategorized
Thank you a further amazing article. The place more may possibly any one get that sort of details in this particular excellent way of publishing? I own a demonstration next 7 days, that i’m for the search for similarly info http://www.fildenaonline.com.
Seems to me that apps need to be usable, useful, and safe.
Usable is determined by the patient, caregivers, and clinicians, all of whom will have to make some use of a medical app and its data. So usable can’t be determined by doctors on their own.
Useful is another term that tends to be in the eye of the beholder. I think we do best on useful when we bring the stakeholders together and figure out how to work towards our mutually agreed upon goals. EHRs notoriously did not go through this process, and hence are not useful for much of what clinicians are conventionally trying to do. (Nevermind for those clinicians who are trying to take partnering with patients to the next step.)
Now how to define safe…this is the part I’ve thought about the least so far, mainly because conventional outpatient care strikes me as pretty unsafe already. But of course we have more tolerance for errors of omission (what? nobody addressed your pain and depression all this time? And no one told you benzos increase the risk of Alzheimers?) than of commission. And we’re especially leery of commission that involves using some new fangled approach that isn’t already being used by many of our colleagues. (Because the “accepted standard of care” feels protective to us.)
I do agree overall w Jaan Sidorov: clinicians who practice on the front line tend to have a good sense of what practical problems might arise, and should be more involved in the app development process. This is necessary, but probably not in itself sufficient to create apps that are usable, useful, and safe.
I agree that doctors are in the best position to evaluate whether or not a health app is medically accurate and useful. We asked 65,000+ doctors in our expert network to review 10’s of thousands of the most popular health apps to create the “Top Health and Medical Apps report” showing the top 100 apps in iOS and Android, plus the top 10 apps in each of 30 categories. Tens of thousands of health apps are rated already, and doctors continue to review and rate new apps in “AppRx.” The report is free. healthtap.comhttps://www.healthtap.com/top_health_apps_2014
As a doctor and software developer myself, I completely agree that there is a distinct lack of doctors and healthcare professionals in the web and smartphone app industry. I really feel that the future of medical software lies in the tech-minded doctors.
The staggered regulation model is an interesting idea. I’d love to hear more about how this works from somebody who has been following the conversation around this one.