By now most of us know that the Affordable Care Act, better known as "Obamacare" is nearly 3000 pages long, but the rules and regulations of the bill attached to it are approximately an additional 17,000 pages long . At this point we may be asking ourselves who has read this bill in its entirety and more importantly who has the proper interpretation of its contents? Senator Nancy Pelosi was under the impression that the "only" way to know what was in it was to pass the legislation meaning most of congress had to remain in the dark before deeming it into law? Informed consent being exampled in a new era?
But, before Americans get all railed up about the Employer Mandate, the Physician Mandate for EMR(electronic medical records), the Individual Mandate or the Caps of "out of pocket" limits ; we may have become temporarily diverted from an obscure section buried deeply in the new law. Section 2521 of the Affordable Care Act(H.R. 3962): The Creation of a National Medical Device Registry(NMDR). At first this section appears to be a rather insidious part of legalize until you begin to "put the pieces together" logically.
The Affordable Care Act was passed after the House Bill (H.R. 3200) was defeated and modified by the Senate into H.R. 3590. When both houses reconciled the health law, the President's Bill(H.R.3962) was approved. However, there is still an amended bill of HR.S 3962 that rests still in the House which is H.R. 4872.
Section 2521 which was admitted in H.R. 3200 has been modified a couple of times since its inception into more digestible language lately , but the original language reads that the Secretary of U.S.H.H.S is to create a "mandate" for establishing a NMDR to "facilitate analysis of postmarket safety outcome data on each (medical) device that is either class 2 or class 3". Class 2 devices are RFID transponders also known as micro-chips which were approved for human implantation by the U.S.F.D.A.
The Section on page 1000 later reads that Class 3 are devices used "on" or "in" a patient and Class 2 are those for life supporting or sustaining abilities. The FDA gave the classification for these devices and has also approved radio-frequency transponder systems to be included with such devices. On page 1004 the proposal for Mega-Data collection(data-mining) of all EMR is described. These devices are to be covered by all those signing on to ACA.
This obscure section(2521) is implementing the creation of a NMDR which is essentially what the EMR does and further states that any and all medical devices will have capability for "electronic tracking" and that these devices will be "implantable" . The Section previously read " class 2 and class 3 implantable devices in all patients...." This therefore allows the USHHS/USDHS to collect all viable data from medical devices inside or on a patient in real time. All real-time physiologic (biologic) events of a subject can and will be recorded in real-time. Why were "implantable" devices that are RFID being written into healthcare laws congruently even in earlier drafts of the law? Why was it also being "mandated"(covered) at the same time a NMDR is being created? Before there are too many wrong impressions growing out of this before it goes into effect, perhaps U.S.HHS needs to take time to interpret this law for the Americans who will be "covered" by ACA more precisely. Again the law has evolved since its inception from several bills submitted to the House and Senate and the language of "micro-chipping" all who subscribe to ACA has been redacted as of late, but you really won't find it in there now. It is creative legalize that is left to interpret and the "open-ended" feel that gives the Secretary of HHS unrestrained "discretion" to implement the NMDR to her liking.
Today, the new language in the bill is not exactly direct, but is suggestive of allowing or "mandating" futuristically RFID devices that could become implantable under some situation deemed necessary. The NMDR is merely a" prescriptive pretext" necessary to facilitating it to becoming. "Micro-chipping" , no matter how cost-effective and practical still makes Americans very nervous. "Mandated" RFID can not be rolled out until later under emergent scenarios(epidemics/loss or overload of paper files) or the extreme commercial and acceptable ease of consumer uses of being micro-chipped.
If one were to read this section today(NMDR/RFID) , the words "implantable" has been replaced by "sale and taxing" of Class 2 devices". But, if healthcare legislation is now considered a "tax", then it would also make perfect sense to replace that "lingo" with this new designation. The language needs to be examined either way and the questions need to be asked by constituents about defining "Implantable" bio-medical device uses termed Class 2 or Class 3 and how the NMDR will be utilized to gather data on its users by such devices. The new language is not "written in", it is more the "implied" notion of how technology will be utilized in the new world of healthcare extraction and extrapolation. More on that later.
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