Wednesday, October 3, 2012

ON NOTICE: Medical consent forms include device tracking, reports to FDA

BTC -  The great thing about the Internet is that one can publish pertinent information with little to no analysis and others may draw conclusions, make assessments and determine the meaning of events on their own.  Use of personal judgement and critical thinking skills are encouraged by readers finding content of interest on this blog.

Today on a routine visit to a dermatology office I was asked to sign a boilerplate Consent for Treatment  form.


One important item of note on this boilerplate was an opt-out item in the consent for treatment:

"The following information has been explained to me to the degree that I wish to have it discussed:...
*Possible recognized alternative methods of treatment, including non-treatment;" 

The most relevant information to make this a blogworthy item is the item number 3.

3.  Federal Regulations ( 21 CFR Part 821) require manufacturers to track certain medical devices, and assist the U.S. Food & Drug Administration (FDA) with notification to individuals in the event that a certain medical device presents serious health risks.  I authorize and agree to the release of my contact information to the manufacturer:___________________________________________ for the this tracking purpose only.  I understand that the manufacturer may notify me, if necessary, of important safety information about my medical device, and may release my information to the FDA if ordered to do so.  I understand that this consent is valid for the life of the medical device. 

I had no need of this clause at the time of my personal treatment and did not consent to medical device tracking. Since there is no device for the FDA to track inside my person for medical treatment or any other purpose, I signed the form. It was non-applicable.

This is a live medical consent form being signed by hundreds of people every day seeking treatment for any number of ailments. It cites Federal Regulatory requirements for tracking medical devices. It did pique my curiosities about subcutaneous device implants during my visit to this Dermatology office. RFID tags have been approved for internal and subcutaneous use, and in this regulatory case, medical tracking of human beings and animals by the FDA. 

As this regulation exists live on this form, I see concerns about this may have been massaged away prematurely by advocates who might believe overt threat of internal RFID tracking is "over". Fights were won to ensure medical device tracking was not baked into US national healthcare laws passed in 2010. It was a victory indeed.

However, the public often forgets or misses information about how Administrative fiat in federal agencies is a strong second option for those lobbying for widely administered rules or regulations in public and private sectors. A strong bureaucratic incentive is what lobbys may lead with to create a regulation they could not get passed by way of US Congress. A good example of this would be the Executive branch using Executive Orders to compell public agencies to administer regulations, or even policy, executing items exactly as they would a law.

A consent form like this serves as a flag or a marker to those of us who know governments and corporations live by rules and consequently die, or suffer consequence, of breaking those rules.  The rule will apply today to those who have pacemakers, diabetics with unique conditions, epileptics and other critical health problems solved by the graces of modern technology.  Unfortunately, we also live in a society today which rewards surveillance and data mining contractors handsomely for watching the public in predatory ways counter to human rights, the US Constitution, State Constitutions and the natural will of the public.

I am far more concerned about manufacturers monitoring patients or given a de-facto surveillance license by the FDA for non-health purposes, because they can. Consent forms like this give them the power to do so.  Regulatory compliance holds threat of litigation against device manufacturers for NOT monitoring patients.

Meanwhile, patients maintain hold of the ultimate power: consent. Unless, of course, they sign that away.

Thankfully, there is a way to opt out.  Medical implants are voluntary. They may seem involuntary for those who may need them to survive.  However, most moderately healthy people have no medical need for an RFID implant.  They would never give consent to an arbitrary medical manufacturer to track them.


Subcutaneous RFID adoption is still a novelty item for screwball hackers resistent to living in the woods without being wired in.  By rule of thumb, the .03% of 1% of RFID implant volunteers aren't going to lobby government to do what they do on their own, even by Andy Greenberg's standards.  It's okay to tell the RFID Toys author, who proseletyzes RFID chip adoption, "Go ahead.  It's still America. Do what you want.  It's your body."

Voluntary internalized RFID is not going to catch on with parents or responsible parties in the 1st, 2nd, 3rd or any world unless there is a nefarious and ubiquitous economic or government mandate. They won't be volunteering up for it. Even if Texas and Florida education systems may compulsively encourage dressing kids with an RFID tag. Parents generally don't want Institutions to have more power to watch their children than they do.  They will challenge this or put their kids in another education system.

The rule of consent is the way the public Beats The Chip.

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