Online Roundtable Discussion Among Clinical Doctors 【Part 2】

Facilitator:            In this session, we will ask some questions to the doctor's opinions at the previous roundtable discussion. We would like to have an exchange of opinions on these questions.

Facilitator:            Let’s get started. First question. I have heard that diagnoses using AI,, including diagnostic imaging, have become a black box and physicians are unable to explain them. We discussed who is responsible for the diagnosis. Is this also a challenge for the spread of AI diagnosis? It seems that several AI algorithmic diagnostics have received FDA approval in the U.S. Is there a difference in thinking between Japan and the U.S.?

Dr. Shinpaku: 　 I think another issue is that doctors themselves do not have knowledge of AI algorithms. On the other hand, there is also the background that engineers do not know about medicine, so I think it would be better to develop and operate while leaning on each other....

DIO:　　　　　　In this regard, for example, there are still diseases for which the mechanism cannot be explained, and drugs for which the mechanism cannot be explained, although the number of such cases has decreased considerably. In medical research, there are studies that clarify the mechanisms of such things, and there are also observational studies, which are things like, “We looked at the results of intervention A and B, and A seems to be more effective, although we don't know why.” So, not knowing the mechanism leading to the diagnosis by Deep Leaning is probably not a major issue, isn’t it? I think it's going to be an active study to clarify that (laughs).
The question of “who is responsible for the diagnosis” may be a difficult one, but I think the current trend is basically that the diagnosing physician should be responsible.... At this point, the discussion has not reached that level, and I feel that the issue of utilizing Deep Leaning has not yet been discussed in Japan.

Facilitator:            Is the reason why it has not been discussed in Japan yet because there is currently no need for it?

DIO:　　　　　　It is not so much that there is no need, but rather that we don't know much about the application of  Deep Learning to medicine, including myself. As Dr. Shinpaku mentioned earlier, I think the connection between medical professionals and technicians will be important.

Facilitator:            I see, that is an issue that we should pay attention to in the future. Technicians and doctors need to communicate and understand each other.
Now, We will move on to another question.

Facilitator:            Medication adherence is a challenge for pharmaceutical companies and for improving the effectiveness of drugs. Several medication adherence apps are on the market in the U.S. and are also the business of pharmaceutical companies. Several non-pharmaceutical companies have started medication adherence support services in Japan, partly because it became mandatory last year for pharmacists to follow up with patients on their medications. Are there any digital tools for medication adherence being talked about within hospitals?

Dr. Shinpaku: 　 I have actually never heard of medication adherence support using digital tools... I have the impression that more patients have recently added their medication data to the app, but I'm not sure if that's the only thing yet... I would think CureApp, the app for smoking cessation treatment, works between smoking cessation visits to keep patients motivated, but that is quite cutting edge so far.

Facilitator:            I see, there would be not many cases where apps are being incorporated into treatment.

Dr. Shinpaku: 　 Perhaps CureApp is the first nicotine addiction therapeutics app receives regulatory approval in Japan.

Dr. KOTATSU:       There are very few (therapeutic app receives regulatory approval) yet. In the diabetes treatment, BlueStar seems to be following CureApp.

Dr. Shinpaku: 　 I heard that CureApp's app to treat hypertension had completed its clinical trial.
 (CureApp Hypertension Therapeutics App was approved by the Pharmaceutical Affairs and Food Sanitation Council's Program Medical Devices Investigation Committee on March 9, 2022, for this therapeutic application. *⁰) 
I think the (Digital Therapeutics for) diabetes field seems to be advancing.

Dr. KOTATSU:       There are several apps in the diabetes field that can be retrofitted to already approved medical devices. “OneTouch” series self-monitoring blood glucose meters from LifeScan Japan synchronize with the “OneTouch Reveal” app*⁷, tracking average blood glucose levels, dietary intake, medication doses, and exercise data. Similarly, Roche’s “AccuChek” series of blood glucose self-monitors*⁸ can be connected to the “mySugr” app*⁹. I think that Medtronic also had an app (“Guardian Connect” *¹⁰ app) linked. The image is docking a highly compatible app with a medical device already approved and gaining market recognition.

Facilitator:            If the app is used in healthcare by docking the app with an approved medical device, digital health for apps would be expanded.

Dr. KOTATSU:       Besides, there are lifestyle apps overseas such as MyFitnessPal*¹, Glucose Buddy*², Meal IQ*³, DiabetesConnect*⁴, Diabetes:M*⁵, BEATdiabetes*⁶ and so on. These are, roughly speaking, the exercise and diet coaching apps available with blood glucose recording. 
For “FreeStyle Libre,” there is an app called “LibreLink” that links to the sensor, and it is possible to see the patient's smartphone in the outpatient care. We used to get the patient's sensor connect it to the PC at the hospital and check it through the app on its PC. But that has become much easier now.

Dr. Shinpaku: 　 “FreeStyle Libre” is quite revolutionary.

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