Recently, I participated in the evaluation of a "smart bed" for a post-acute care entity here in St Petersburg. After the evaluation was completed, it became apparent to me that we had no formal evaluation process that we could use to assure that any IoHT device that came our way would fulfill our requirements for patient safety and organizational fit. Therefore, I decided to prepare a checklist, which could be used by any care provider to evaluate an IoHT device, be it a smartwatch, a portable EKG, or any one of the myriad wearables which are now coming to market.
1. Does use of the device/wearable fit within the organization's values and culture?
2. Impact on care and quality of life for patients, residents, and families?
3. Will it enhance caregiver productivity? How?
4. Is it HIPAA compliant?
5. Has it been cleared by the FDA? When? Approved by the FDA? When?
6. What are the privacy and security protections?
7. Is the device/wearable interoperable with the organization's Electronic Health Record?
8. With respect to user experience-is the device easy to understand and use? Is there an operating manual readily available? Is there a help desk at the manufacturer?
9. Can you access proof of concept studies?
10. Installation issues and ongoing maintenance and support? How will upgrades/improvements be handled?
11. Smartphone app for iPhone and Android?
12. Device/wearable website access available?
13. Performance compared to comparable devices/wearables?
14. Are there daily or weekly use reports? Dashboards?
15. Does the device/wearable pass muster with State and Federal laws and regulations?
16. Is the device? When? Note: The Continua Compliance and Certification programs help organizations to validate both compliance and interoperability for personal connected health devices and services in accordance to the Continua Design Guidelines (CDG)