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In the last few years, many wearable devices have found widespread support amongst the public. Clinicians have also encouraged clients and patients to purchase wearable healthcare devices to monitor and detect changes in health. These products include blood pressure cuffs; pulse oximeters; heart rate variability devices such as the Oura ring or smartwatches with movement trackers made by Apple or Fitbit; smart home technology, and many other devices. Given the popularity of smartphones and clothing designed with properly-sized pockets to hold them, it could be argued that the smartphones themselves are healthcare wearable devices. However, smartphones are not traditionally included in the wearables category.
How to Use Wearable Devices in Healthcare
Wearables can often use smartphones to either collect or collect and transmit data from wearables, typically by a wireless sensor that connects to the smartphone using Bluetooth technology. Wearables can also connect sensors attached to the person’s body using a wire on a finger, earlobe, or adhesive pad on one end. The other end of that wire then connects to one or more of the “ports” found at the base of many phones, such as where one connects earbuds or charges the phone.
Once connected, readings can be seen, gathered, and sometimes transmitted using an app made by the wearable device manufacturer. A non-healthcare example would be a smartphone app designed to listen to music using earbuds to engage with iTunes or Apple Music on one’s smartphone.
Using Wearable Devices In Telehealth
The explosion in the use of wearable devices in healthcare is not limited to the medical field. Modern technology companies are also exploring the benefits of wearable health monitoring devices for health-conscious users. Most telehealth practitioners working with people using health monitoring devices to date have simply asked their clients and patients to share their digital measurements via telehealth video screens or telephones.
This simple process can allow medical and behavioral professionals to comment on readings or offer broad guidance related to devices that do not transmit digital information and therefore are not included in the definition of wearable devices. The danger is that the device is inaccurate. Assume, for example, that a blood pressure cuff gives a false negative reading. A patient could incorrectly assume they can safely engage in otherwise dangerous activities and have a heart attack. Lawsuits could ensue related to the faulty device. Clinicians encouraging the use of defective devices could also be held responsible.
Do Healthcare Wearable Devices Involve Telehealth?
Yes, wearable devices used in healthcare can involve telehealth if protected health information (PHI) is transmitted from the device to the clinician or, for example, to a clinician’s electronic health record (EHR). That means if an app collects data, de-identifies that data from the sender’s PHI, and sends it to a platform in Silicon Valley to create an easy-to-read chart, which then gets sent to the consumer’s smart device, it most often isn’t considered telehealth. When data leaves that device and is sent to a clinician or other covered entity, it most likely is considered PHI.
Clinicians expose themselves to HIPAA violations if they digitally receive PHI data in any form, including having a simple picture of that data sent to them electronically.
- For example, if an image of a de-identified sleep chart is texted to a practitioner via iMessage, then the practitioner is subject to HIPAA regulations because iMessage is not HIPAA-compliant. When sending this text, the transmission from a client or patient smartphone will add PHI. To properly transmit images with PHI would be to use a HIPAA-compliant texting service or EHR.
- Transmitting healthcare data from a wearable device to a covered entity legally meets the definition of telehealth in most states. It, therefore, is subject to all the restrictions imposed on practitioners obtaining and reading wearable device data over state lines. Clinicians may also want to proceed accordingly when users travel over state lines.
However, when the clinician recommends remote patient monitoring through wearable technology, many other factors come into play. The distinction between appropriate and inappropriate devices is unclear to many clinicians. The Federal Trade Commission offers an interactive tool to help stakeholders understand the laws related to such apps.
As increasingly more sophisticated wearable health monitoring devices are released into the marketplace. Wearable health monitoring devices also provide healthcare workers with a much more detailed database of patients’ physical conditions.
Other Considerations for Clinicians Suggesting The Use of Wearable Devices in Healthcare
Wearable devices pose many new opportunities for clients and patients to benefit by better understanding how to measure and optimize their health. Clinicians working with people who rely on healthcare devices or apps may wish to encourage looking into the scientific basis behind the technology. Areas of concern would include, at the very least, accuracy, reliability, and privacy.
- Accuracy. Are the device’s metrics meaningful? Are they being correctly measured?
- Reliability. Does the consistently measure behaviors over time?
- Privacy. Who can see the data being collected? Is the app password protected? Encourage the client to toggle off data sharing with developers of the device. Invitations for data sharing may seem innocuous, but they open the door for the developer to see and collect health data from unsuspecting users.
Practitioners would benefit by knowing that the HIPAA breach notification rules are the focus of increased attention by the Federal Trade Commission (FTC). That US government office is working in tandem with other requires that covered entities, including device manufacturers and users holding fertility, heart health, glucose levels, and other health data, must notify consumers in the event of a breach. Before recommending devices to clients and patients, understand basic cautions and proceed accordingly.
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