Tag Archives: Class II

Healthcare, RFID and Medical Devices: Worry or Not?

Kaye Beach

July 10, 2011

In this post I raise two issues related to RFID and medical devices.  RFID is a generic term for technologies that use radio waves to automatically identify people or objects.

One of these issues you shouldn’t worry about but the other might be cause for concern.

Although the assertion that the Affordable Care Act mandates that the majority of people receive a RFID chip implant has been soundly debunked but there has been a resurgence in the hoax.  It is concerning to see that otherwise cautious and credible people are falling for it and perpetuating this disinformation.  As I have stated elsewhere, creditability is essential and it is an all or nothing kind of a deal.

Here is the basic claim being made;

The Obama Health care bill under Class II (Paragraph 1, Section B) specifically includes ‘‘(ii) a class II device that is implantable.” Then on page 1004 it describes what the term “data” means in paragraph 1, section B:

‘‘(B) In this paragraph, the term ‘data’ refers to in
formation respecting a device described in paragraph (1),  including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of  data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary”

What exactly is a class II device that is implantable? Lets see…

Approved by the FDA, a class II implantable device is a “implantable radiofrequency transponder system for patient identification and health information.” The purpose of a class II device is to collect data in medical patients such as “claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary.”

This sort of device would be implanted in the majority of people who opt to become covered by the public health care option.


The claim is faulty from the get go.  Although implantable RFID chips are a Class II device, the  aren’t the only implantable device that is a Class II medical device.

In the United States, medical devices are regulated by the FED, the Food and Drug Administration. Medical devices can be defined as any physical item useful for diagnostic, monitoring, or therapeutic purposes.

There are three classes of medical devices.  Devices are regulated according to their intended use and by level of risk posed to the patient with a Class I device being the most lightly regulated due their non invasive nature and slimmer possibility for harming a person and Class III being the most heavily regulated.  link Examples of Class I devices  include bandages and  hand held surgical instruments. Examples of Class II medical devices includes dental fillings, sutures, and yes, RFID implantable chips.

RFID chips are only one example of a Class II implantable device. 

What is a Class II medical device?

Class II devices have a higher potential to cause harm and require both general and special controls, such as special labeling, mandatory performance standards, and postmarket surveillance. These devices are typically nonimplanted, although some are partially invasive. Examples include x-ray machines, wheelchairs, infusion pumps, and surgical needles. Link

Also, the original (HR 3200)  bill did not mandate that anyone must have anything implanted. the language was actually proposing a national registry of medical devices  and furthermore this language was not included in the version (HR 3590) of the bill that actually passed into law.  A registry of medical devices certainly could be something to worry about but that is not what is being addressed by the above claims that are being passed  from person to person around like a bad rash.

Mark Lerner, co-founder of the Constitutional Alliance, researched the issue and provides this statement on his findings regarding the matter;

I have been asked if RFID (chips) implants are mandated as part of the Patient Protection and Affordable Care Act (HR3590, Public Law 111-148) often referred to as “Obamacare”. The answer is “No”.

An earlier version of the legislation (HR3200, 111th Congress) did allow for class II devices that are “implantable” but that legislation never made it out of the House of Representatives.

Do not take my word for it; visit http://thomas.loc.gov/home/LegislativeData.php and select “advanced search”, then select 111th Congress (2009-2010) and enter the bill number HR3590.

You can do the same for HR3200 and find out that HR3200 never was passed, much less signed into law. If you follow the directions I have provided you will be able to read and do a word search for the word “implantable”in both of the pieces of legislation and determine the last Congressional action taken.

I want to say unequivocally there are times when incorrect information is shared not because people intentionally are attempting to mislead others but rather because we do not always do our homework before passing on emails and other information. Let the man or woman or has never shared erroneous information come forward today and you will find nobody including myself that has not committed this error.”

Now here is an issue that involves RFID and medical device that may warrant some legitimate concern;

Published July 10, 2012 in the RFiD Journal

FDA Issues Proposed Rules for Unique Identification System for Medical Devices

The medical manufacturing and health-care industries have 120 days to comment on the new rules, which will require many medical devices to carry a printed text identification number and bar-code label or RFID tag ID that would be stored on an FDA database.

Read more

The concern is that medical devices that are either worn or implanted into a person that carry a unique identification number whether it be by bar code, RFID or simply text printed on the device-is traceable and could be combined with other personal data.  I find the idea, on its face, to be worrisome and will be doing some addition reading on this issue.

For more information on the privacy  problems with item level RFID tagging, read;

Bye Bye Wal-Mart: Wal-Mart Radio Tags to Track Clothing