What’s Up With the National Medical Device Registry?


I’ve seen where people believe this is some sort of plot to implant devices into our bodies. While I don’t think it goes that far, it is a bit Orwellian, nonetheless. The part of the health care bill I’m referring to is page 1013 to 1020. There’s some pretty creepy language. A few examples:

The Secretary shall establish a national medical device registry (in this subsection referred to as the‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that—

‘‘(A) is or has been used in or on a patient; and

‘‘(B) is—

‘‘(i) a class III device; or

‘‘(ii) a class II device that is implantable,

life-supporting, or life-sustaining.

‘‘(2) In developing the registry, the Secretary shall,

in consultation with the Commissioner of Food and Drugs,

the Administrator of the Centers for Medicare & Medicaid

Services, the head of the Office of the National Coordinator for Health Information Technology, and the Sec-retary of Veterans Affairs, determine the best methods

for …

Does that sound a tad bit creepy to you? Yeah, me, too. But then there’s this on page 1015.

‘‘(iii) other postmarket device surveillance
activities of the Secretary authorized by this

What’s up with that? Device surveillance? But it gets creepier still. (Page 1018)

‘‘(D) shall establish requirements for regular
and timely reports to the Secretary
, which shall be
included in the registry, concerning adverse event
trends, adverse event patterns, incidence and preva-
lence of adverse events, and other information the
Secretary determines appropriate
, which may include
data on comparative safety and outcomes trends;
and …

That’s all I can take. If you have some time on your hands, feel free to pour through the bill. Let me know what else you find. I don’t know, the lefties out there scream about “privacy” but why don’t they have a problem with this? Sounds like a big invasion of privacy to me. Does the federal government need a HIPAA release to garner this information? Or, once they nationalize health care are our medical records there at their beck and call?

Reconciliation HR 4872 Full Text