Monday, January 30, 2017

Are those Mobile Health Apps reliable ?

The line between pharma and health information technology is blurring. SAAD (Software as a Device) stands alongside  SAAS (Software as a Service)

The progress is punctuated by the FDA which will require vetting of health software when it is linked to treatments.  No such requirement has been proposed for electronic health records, but is now being required for mobile health applications and/or remote monitoring.

In the past the FDA (Food and Drug Administration) was responsible for the safety of food stuffs. It is also responsible for the safety and efficacy of pharmaceuticals, and medical devices.  The vetting of pharmaceuticals is complex and very expensive.  The cost of new drug development is quoted as between 450 million dollars and 900 million dollars.  Pharma uses these figures to justify the cost of new proprietary formulations. The patents are valid for 16 years.  When a new drug makes the 16 year mark it becomes available to other pharmaceutical companies to be sold as generic drugs,  and the cost drops significantly.

If and when SAAD becomes available for diagnosis and treatment some SAMD will require FDA approval. Usually this takes at least 12 to 24 months, unless there are urgent medical considerations.  I would expect a price increase for SAAS.

FDA floats new draft guidance, created by international group, on software as a medical device

Therefore it is not at all a guaranteed win.

Finally, mHealth is the winner : Software as a drug? - Health Files by Rajendra Pratap Gupta | ET HealthWorld

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