Article: Establishing Trust in Wearable Medical Devices

Many of the topics covered in this article I have covered in this blog. Most recently, my discussion of signal detection and the Apple Watch (https://medicalremoteprogramming.blogspot.com/2019/12/signal-detection-and-apple-watch.html) that I suggest that you read after reading this article from Machine Design.

Here's the link to the article: https://www.machinedesign.com/medical-design/article/21122718/establishing-trust-in-healthcare-wearables?utm_source=MN+MD+Medical+Design&utm_medium=email&utm_campaign=CPS200206038&o_eid=7596G0176945B2B&rdx.ident%5Bpull%5D=omeda%7C7596G0176945B2B&oly_enc_id=7596G0176945B2B

Here are a few quotes from the article.

To say that we can get personal health insight from continuous monitoring presumes a “chain of trust.” In other words: 

• The interpretation of any data must not only be accurate but reliable. The challenge lies in handling “borderline” data. Any interpreting strategy or algorithm faces data sets that it finds ambiguous. For an algorithm to be reliable, users must be able to quantitatively understand its detection limits and error characteristics.

• The data and/or its interpretation must reliably reach the decision-maker for it to become actionable.

• The data must be correctly associated with historical records of the patient for it to have context.

• The data must be proven to be authentic to trigger any meaningful action.

However, using clinical equipment to capture vital signs that are representative of the wearable use cases is often difficult and sometimes inaccurate. To avoid a rash of false positives or false negatives, one must carefully select the population of test subjects and carefully develop the representative use cases. It’s also important to compare data from the patient’s own history or baseline, keeping in mind that this baseline isn’t static as the patient ages and undergoes other changes.