This review appeared last week:
No longer sci-fi: our bodies as computers
In an era of wrist worn wearables and other emerging wearable technologies, the American Bar Association has published an article examining some of their legal ramifications.
The rise of ambient computing
AI-powered wearables include smart watches, fitness trackers, glasses, headsets, knee braces, ear buds, implanted devices, rings and other patient-centred wearable health devices. For example, Apple Watch has a built-in electrocardiogram monitoring heart rhythms and atrial fibrillation. Smart sweat sensors can detect dehydration and inflammation biomarkers in patients.
Digital health implications
Wearable health devices are useful in empowering users to monitor their own health and to broaden access to medical knowledge. They can be a relevant and helpful input in telemedicine enabling doctors to download information from patients. As the functions in wearables continue to expand, the interplay between wearables and digital health is facing increased regulatory scrutiny.
Some legal issues to consider arising from wearable technology include:
- Liability: Wearable manufacturers failing to detect a health risk could become liable if the user becomes ill or suffers harm. Software programs were previously considered a service or good rather than a product, so benefited from a lower liability than product liability. However, if wearable AI software programs cause injury – such as with autonomous vehicles and robotic surgeries – if there is a product defect it will likely be subject to product liability. Wearable manufacturers could be held liable for insufficient warning labels, punitive damages and class actions. Apart from wearable manufacturers, a physician receiving data from a patient’s wearable could also be liable under medical malpractice if s/he fails to provide reasonable care to mitigate a pending health problem indicated in the patient’s data. To date there is minimal case law on a physician’s duty to monitor a patient’s wearable data.
- Privacy: wearable AI devices rely on large datasets. In the US, the Health Insurance Portability and Accountability Act (HIPAA) is a federal law mandating national standards on privacy (and security) to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. HIPAA, however, only covers data streamed to the patient’s physician. Data not sent to the physician is not protected by HIPAA and therefore not afforded the same privacy protections.
- Security: Cybercriminals and hackers can target data storage. Wearable devices usually have fewer security protections and updated firewalls compared to a laptop, smartphone or web-based storage site. For example, MyFitness Pal was hacked in 2018, exposing the data of up to 150 million users subsequently sold on the dark web.
- Data accuracy: Data needs to be accurate to be reliable especially in digital health. False positives can lead to unnecessary testing and overtreatment and mislead physicians when making a diagnosis. In 2017, a Stanford study found seven wearable fitness trackers poorly estimated calories burned. FDA approval is not currently required for most wearables. FDA approval is only required for wearables used to diagnose or treat specific, identified diseases.
- Bias: AI-based algorithms used in healthcare, facial recognition systems, criminal sentencing and employment can produce discriminatory results when data collected and used to train algorithms are biased.
Wearable devices as medical devices
The more pertinent issue is arguably the regulatory classification of wearables. FDA approval is not currently required for most wearables. FDA approval is only required for wearables used to diagnose or treat specific, identified diseases. The FDA has cybersecurity guidance for wearables classified as medical devices: a device manufacturer must implement a risk management program.
The ABA paper suggests that the FDA should explore implementing regulatory approvals and monitoring for a wider range of wearables including those that measure wellness or lifestyle factors. But the ABA also suggests a more ‘light handed’ approach where wearable manufacturers would self-certify by answering questions about their product and make them available for consumers and physicians.
The regulatory position could be much stricter in Australia. The Therapeutic Goods Administration (TGA) is responsible for classifying and regulating medical devices. Earlier this year the TGA consulted on amending classification rules for software-based products. Whilst the TGA does not regulate merely health and lifestyle apps or wellness devices, software products become a medical device when they are intended to perform a medical function such as providing information to monitor a disease, specifying a treatment or are controlling a hardware medical device.
More here:
Almost at the same time this detailed review of where one manifestation is going:
Withings ScanWatch focuses on health insights
Withings has released a stylish smartwatch that could be massively attractive to older Australians. That’s because the Withings ScanWatch measures a swag of metrics such as heart rate around the clock, along with irregular low and high heart rates over time, and purports to detect atrial fibrillation (AFib). It also has a blood oxygen (SpO2) monitor that helps detect breathing irregularities and sleep apnoea, and monitors sleep.
Like some of the French company’s earlier digital watches, it looks like an old-fashioned analog watch with regular hands and a crown. The giveaway that it’s no ordinary watch is the small digital window near the top that is surprisingly useful. You can view basic metrics such as heart rate, steps, distance moved, height gained by rotating the crown.
You can initiate ECG and oxygen saturation measurements by placing your hand over the side of the watch, set an alarm and timer, and select from a variety of workouts for tracking via that window.
The watch tells you when your phone receives a call, and SMSs and emails appears in the small window as a horizontally scrolling ticker. You need to read it attentively because once it’s displayed, it’s gone. You can’t make phone calls from the watch.
Most of your health data is accessed through the Withings’ Health Mate app on your phone, which connects to the watch by Bluetooth. You can also access you data through the web.
Scrolling through the app, I can see my steps, whether my latest ECG reading and oxygen saturation reading is normal, my sleep score from last night, whether there is evidence of breathing disturbances, and an assessment of my fitness level.
You can select these categories to view more granular data, although for me the summary is often enough. It’s a human equivalent of a daily roadworthy certificate for your car and you are not dumped unaided into a fire hose of never ending data.
Withings offers useful indications of trends. Today, it said my ECG was normal and there are no days of signs of AFib. You will be told about changes in sleep time.
Unlike some rivals, Withings has obtained formal medical approval from the Australian Therapeutic Goods Administration.
Lots more here:
Reading quietly through this material it seems that what has been an emerging technology is now really coming of age and becoming genuinely useful. While it has taken a while what is offered by the latest versions of watches from Withings and Apple are pretty much unimaginable in capability just a decade ago.
It is a pity the Withings offering seems to lack some more traditional functions of a smartwatch, but it does surely take the health focus to a new level!
The future will be very interesting indeed!
David.
No comments:
Post a Comment