Different digital therapeutics (reSET, reSET-O, Rejoyn) have been around for a bit but I have not seen them added as concepts in Vocabulary. Any thought on getting those added? They’re prescribed like drugs but are not traditional drugs as they are apps, so perhaps under device?
1 Like
Hi Leslie
Welcome to the Community
You made me google what these things are 
. A couple of thoughts:
- Definitely not drugs - they lack all drug attributes (e.g., ingredient, dose form, strength, etc.).
- Not a device - they are digital.
- They are prescribed as part of therapy, so maybe something like drug addiction therapy.
I don’t think there’s a strong use case for these therapies right now to add them urgently, so consider submitting them to SNOMED as new concepts and checking with the Psychiatry Working Group - they will help you.
Tagging @Dymshyts @TatianaSkugarevskaya
reSET-O, at least is a medical device. FDA cleared it under 510(k) number K173681 on 12/10/2018.
It has Product Code PWE which includes the description
Definition – The device is intended to provide cognitive behavioral therapy to treat substance use disorder.
Physical State – The device is a software-based mobile app downloaded onto a smartphone.
Since 2020 there has been one adverse event for Arrhythmia and one Class II recall descripbed by the manufacturer as, “Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin”.
1 Like
Hi!
We have the SNOMED procedures Computerized cognitive behavioral therapy and its descendants. They are not product-specific, but still.
It seems like Procedure may be a good domain for these therapeutics, as they are used for the behavioral therapy. Also, as they are FDA-approved, we may expect the respective CPT4/HCPCS codes to be introduced. What do you think?
1 Like
I would incline to device domain, because Procedure is an act of medical worker aimed to the patient.
Here is an object (piece of software), patient will use by himself (and maybe discuss it with the doctor, but the discussion will be coded separately).
So, I would request it to put it under device hierarchy in SNOMED, similarly to this one:
and actually all the software concepts are under Device hierarchy in SNOMED
@Leslie_SK can you please bring your use case, so think of the optimal process of adding these
I would agree with you and @Dymshyts here that these are Devices, and the process of prescribing them or consulting about them is a separate thing (often a Procedure).
The next step to adding concepts to the vocabularies would be to do a Community Contribution, so when the consensus is reached this page might help.
Thanks, all. Our use case would be to characterize patients who have been prescribed digital therapies. Typically in the EHR we’re finding these therapies listed in the medication/drug data.
As I stated above, these are devices cleared by FDA as Class II. They are Software as a Medical Device, SaMD.
Their use should be in the Device Exposure Table. However, this table may not have all the fields relevant to this type of device. I recommend you start a discussion with the OHDSI Device Working Group.