FDA final guidance on mHealth eases regulation of MDDS, mHealth (updated)

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…)

mHealth: too much to blog, too little time

As always the question is where to start? Perhaps with the FT headline ‘Powerhouse’ UK leads Europe app development, says research, a piece by Daniel Thomas on some research sponsored by Google & Tech City UK. A full version of the report is here. Key findings are that the UK:

  • Has become the largest tech hub in Europe for app development;
  • Received a third of revenues generated from mobile software in Europe last year;
  • Is the base for almost a fifth of European developers of smartphone applications;
  • is believed to be the world’s second most important tech hub after the US;
  • Has about 8,000 companies involved in app development, employing close to 400,000 people.

Apparently almost half of app developers and designers in the UK generate most of their income from apps, although a fifth generate no income from apps at all but rather see them as a hobby.

Staying with the FT, Prof Mike Short has kindly also pointed this editor to another article entitled (more…)