A survey of over 1,200 insured (individual and employer plans) sponsored by research firm HealthMine and conducted by Survey Sampling International shows that only 30 percent of this group would participate in a payer-provided mobile app, despite 89 percent using a smartphone and/or tablet. Even worse, only 18 percent liked to learn health, wellness, and lifestyle information from a mobile app. It demonstrates that current apps are not compelling or engaging–and the huge paradox of payers make them less, not more, attractive. Perhaps this Editor goes out on a limb, but US insurers have a trust problem on multiple levels (as claim deniers, as impossible to deal with); apps they provide are perceived as capturing information an individual doesn’t really want them to see. Overall, users are not using their smartphones for health reference at all–well below 20 percent. The leading use is for tracking fitness (21 percent) and calorie counting (16 percent). Is it that real research on health is the province of the desktop PC, where it’s easier to find and read? They also aren’t using mobile to find their doctors, despite all the hype from ZocDoc and Vitals: 8 percent had used a doctor finder app in the past six months. Mobihealthnews, HealthITOutcomes
As anticipated, FDA issued final non-binding recommendations for guidance yesterday (Monday) that ease regulatory oversight of medical device data systems (MDDS), including image storage and communication devices, and mHealth devices.
In the MDDS guidance document, “(FDA) does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.” It defined MDDS as “a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) The electronic display of medical device data.” along with their hardware and software. It specifically excludes devices that are used in active patient monitoring.
Mobile health apps were covered in a separate and highly detailed guidance document, “Mobile Medical Applications”.
- FDA will regulate only “those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” (more…)