FDA Regulation of Mobile Health 2013

FDA Brad ThompsonFDA at last has published its final guidance on mobile medical apps. Further, the mHealth industry has morphed several times over the last couple years. Consequently, in this second edition, more than 80 percent of the content is new. Download here Not only have I updated the regulatory analysis, but I’m also covering a few new topics like FDA regulation of pharmaceutical apps.  More

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Ethics and HIT

Challenges...
http://jamia.bmj.com/site/icons/amiajnl8946.pdf
  • patient safety should trump all other values; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations;
  • transparency and a commitment to patient safety should govern vendor contracts;
  • institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and
  • vendors, system purchasers, and users should encourage and assist in each others’ efforts to adopt best practices.

e-Behaviorial Health


Benefit from new technologies... enable people to have remote access to CBT

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