FDA’s Clinical Decision Support Guidelines

The FDA admitted “regulatory ambiguity” is hampering technology innovation in healthcare. The agency released three guidance docs last week in an effort to clarify. Developers have waited six years for one: FDA will generally not regulate “clinical decision support tools that allow the provider to independently review the basis for the recommendations.” But some feel the agency didn’t go far enough. There was no mention of how they plan toregulate AI nor hint of adopting a risk-based approach, for example.

Meanwhile, FCC’s Ajit Pai says net neutrality will help telemedicine. But industry insidersshot back saying tiered access would create complications, especially for rural healthcare.

Headlines

After 6-Year Wait, FDA’s Clinical Decision Support Guidelines Get Mixed Reaction
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Amazon Cancels Pharmaceutical License Application In Maine, Raising Questions
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No, Google’s AI Program Can’t Build Your Genome Sequence
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Investors Finally See Big Money In Infertility. And They’re Transforming The Industry
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Should This Massive AI Company Have Your Health Records?
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