The FDA and IEC 80001-1 (Risk Management for Medical Device IT networks)

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#1
As hospitals continue to connect patient monitoring equipment, physician PDAs and laptops to wireless networks, and then collapse those data paths onto traditional IT networks, the closer the US Food and Drug Administration comes to regulating them, according to Computerworld. The focus of the FDA's regulation comes in its recently finalized IEC 80001-1 standard that established Risk Management practices for those networks, the adherence to which may be voluntary, but would determine Medicaid and Medicare reimbursements. 'If you don't comply, then you have two choices. You can have the federal government come in and inspect your hospital, or you can decide not to accept money from Medicare or Medicaid. Voluntary sometimes isn't exactly voluntary,' said Rick Hampton, wireless communications manager for Partners HealthCare System in Boston.
 
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Marcelo

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#3
Great to know FDA wants to use this standard (series in fact, as 3 additional guidance documents are being drafted right now).

We will begin drafting the Brazilian version this year and i was hoping Anvisa would want to work with this standard too..the fact that the FDA is going in this direction is a plus in convincing other regulatos to use it.
 
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