Updated SOFTWARE Act: Still Too Ambiguous For Industry?

While some industry experts say the updated version of the SOFTWARE Act strikes a tenable balance between industry's need for certainty and FDA's need to ensure patient safety, others argue it does not go far enough to explicitly state what kinds of health IT software the agency will not regulate.

While Rep. Marsha Blackburn's most recent version of the SOFTWARE Act reduces criteria FDA could consider when deciding if a health IT software should be regulated compared to previous versions it still gives the agency overarching authority to determine what health software poses higher risk to patients which has some experts conflicted over its significance.

Three days before the House Energy and Commerce Subcommittee unanimously approved the 21st Century Cures bill that includes the measure,...

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