Last week Apple launched their Hypertension Notification Feature (HTNF) on Apple Watch Series 9 or later and Apple Watch Ultra 2 or later (excluding Apple Watch SE). According to Apple the feature is intended for people over 22 years of age who have not been diagnosed with hypertension. It is not intended to be used during pregnancy. The watch uses photoplethysmography (PPG) which is a 14 letter word (44 Scrabble points) which means that the watch looks at blood volume changes through the skin and uses that information to predict who has hypertension. The watch records 60-second segments of PPG signals as inputs. These signals are collected roughly every two hours throughout discreet 30-day evaluation windows. The watch uses the accelerometer to assure that only PPG signals collecting during rest are used are used to assess for hypertension. A blood pressure score is created for each segment. Segments scored during sleep are ignored. While creating the model, the actual blood pressure was assessed by home blood pressure measurement.
Apple’s white paper about the system provides a classic Table 1 of demographic information on training, validation, and testing cohorts:

I was not familiar The Fitzpatrick Scale. It is an assessment of skin color, V and VI are described by Wikipedia as “dark or brown” and “very dark or black” respectively. Pulse oximetry over estimates oxygen saturation in people with darker skin. Apple prospectively assessed hypertension detection for similar problems.
When determining who to alert for hypertension Apple decided to value specificity over sensitiviy to minimize false positives. From the white paper:
A receiver operating characteristic (ROC) curve was generated based on thedevelopment data, and an operating point was selected to prioritize high specificity — minimizing false positives — while also notifying a significant portion of people with hypertension
After the system was complete, Apple did an additional clinical validation study. They enrolled 2,229 people from two cohorts, all-comers without known hypertension risk factors and those at risk of hypertension based on historical blood pressure values and other risk factors. Each person was sent an Omron Evolv Wireless BP cuff (which scored very high in this review) and instructed to measure their blood pressure twice a day as well as wear the Apple Watch at least 12 hours a day.





Blood pressures were scored using the 2017 ACC/AHA hypetension guidelines:

The cohort for this part of the study was admirably diverse

The full set analysis is the original cohort. The Notification Analysis set only includes people who performed the home blood pressure assessments and wore the watch as instructed. They look reasonably similar except for the higher fraction of women in the Notification Analysis Set.
The investigators found that roughly a third of the Notification Set had hypertension and the watch notified about 40% of them. Only 99 of the 1,278 people without hypertension were given notices that they may have hypertension.

Here is how the test performed using a two-way table:

I feel a little bit out of my element since this is a test being being done in the background on people with no pre-test suspicion of disease. This is unlike any test I have ever ordered or really thought about. It is not a screening situation, where you want to maximize sensitivity at the expense of specificity in order to move a disease enriched population to more specific downstream studies. I think Apple’s description for their rational for tuning the ROC curves is appropriate. They want to capture people with hypertension while minimizing any unnecessary alarm and inconvenience for their customers with false positives.
The FDA application includes information from a 2-year study that is not further described. But it describes that specificity remains high month after month and that almost all of the false positives occur only in the first month.

I am curious, but the data is not provided, if the Hypertension Detection System increases sensitivity over the two years? Does it pick up additional cases of true positives? That would be cool if it did.
If you want to turn hypertension detection on for your Apple Watch, go into the Health App and scroll down to hypertension detection and answer the two questions and then follow through the four panels which describe how it works and to do home BP monitoring for more accurate diagnosis and then a generic warning that hypertension is not a heart attack. The last panel is not from the onboarding flow, but is another panel about hypertension that the health app provides. Nice.






I have hypertension, but I want to play with the warning system so I lied during set up regarding this diagnosis.
Apple received FDA approval for Hypertension Detection. You can read the regulatory filing and response here.









