RFID Law Blog

Several states, including California and Florida, are pursuing ePedigree requirements that may include RFID. There are also more than 20 states considering legislation to regulate RFID in some capacity. The role of the federal government versus that of the states is important for those in the RFID space to understand and determine how best to address their public policy interests. 

If you’re going to be in Washington, DC on Tuesday, June 17^th, you’ll want to check out “Congress vs. the States,” a business regulatory discussion being held at the McKenna Long & Aldridge LLP office at 1900 K Street NW. The event will be chaired by Lawrence Ebner, a partner at McKenna and presenters will include:

• S. William Becker, Executive Director, National Association of Clean Air Agencies
• Ronald A. Cass, Chairman of the Center For the Rule of Law and Dean Emeritus,Boston University School of Law
• Robin S. Conrad, Executive Vice President, National Chamber Litigation Center
• Michael S. Greve, John G. Searle Scholar, American Enterprise Institute for Public Policy Research
• Douglas T. Nelson, Executive Vice President and General Counsel, CropLife America
• Raymond C. Scheppach, Executive Director, National Governors Association
• David C. Shonka, Principal Deputy General Counsel, Federal Trade Commission

Registration is free, but make sure to RSVP here by June 9^th, as space is limited. You can view the complete agenda here.

| Posted By RFIDblogger In Drug Chain Security , Federal Legislation , Government Usage of RFID , State Legislation | Permalink | 0 Comments

Legislation was introduced this week to require that all US passports be made with only US-manufactured technology, including the RFID-chip.  The text of the bill reads as follows...

| Posted By RFIDblogger In Federal Legislation , Federal Legislation | Permalink | 0 Comments

McKenna Long & Aldridge recently published an advisory on the updated rules governing the SAFETY Act titled "New FAR Provisions Mandate Consideration of the SAFETY Act in Federal Procurements."  To read more about the SAFETY Act, revisit our past posts: Experts Discuss RFID's Role in Securing America's Ports, How the SAFETY Act affects the RFID Industry and Presentations from RFID Journal Live! 2007.

| Posted By RFIDblogger In Federal Legislation | Permalink | 0 Comments

Last Thursday, the US Congress approved new legislation concerning the Food and Drug Administration and passed it on to President Bush for ratification. The FDA bill included among other things, provisions that tasked various industry segments and department of government with ensuring effective tracking standards for pharmaceutical products. The bill’s language includes the following:

| Posted By RFIDblogger In Federal Legislation | Permalink | 1 Comments

Ray Biagini, partner in Product Liability defense at McKenna Long & Aldridge LLP, recently gave an interview with RFID Connections regarding the SAFETY Act and how it relates to the RFID business.  The SAFETY Act is an important peice of legislation from 2002 that was passed to protect private companies selling anti-terror technology to the government.

The interview can be accessed in text or podcast here. 

| Posted By RFIDblogger In Federal Legislation | Permalink | 0 Comments

On June 14, 2007 Rep. Dan Burton (R-IN) introduced a bill to the House that would mandate anti-counterfeiting technology in prescription drug packages, primarily highlighting RFID technology or "similar trace and track technologies that have an equivalent function." In addition to mandating an e-pedigree for the drug shipments, the drug packaging would also be required to have a feature that would visibly indicate if a drug package had been tampered with. The bill, H.R. 2716, charges the Secretary of Health and Human Services, which oversees the FDA, to implement this task.

H.R. 2716 also includes a Privacy Protection clause, which prohibits any personal information on the user of the prescription drug or the health care practitioner from being contained on the tag. Advertising would also not be allowed to be contained on or transmitted from the tag.

The bill has so far been referred to the House Committee on Energy and Commerce.

Continuing with the previous discussion on this blog about new pharma legislation, the debate in Congress over how best to utilize technology to address epedigree and anti-counterfeiting interests has now migrated to the House.

Those interested in the outcome of this debate -- whether RFID vendors, pharma manufacturers, wholesalers, retailers, etc -- the opportunity to influence the outcome is at hand.

| Posted By RFIDblogger In Federal Legislation | Permalink | 1 Comments

In response to several questions about my previous post:

The Amendment language doesn't "prohibit" the use of RFID by the pharmaceutical industry.

But the language specifies that manufacturers must use an anti-counterfeiting technology that is visible with the naked eye and does not require a scanner or reader to function. That is not RFID, obviously.

Now I can see the argument that a company could use both -- RFID to satisfy the requirement to provide a unique identifier and another technology to visually authenticate the drug without needing a reader or scanner. But that could be redundant and expensive.

There are lots of conceivable ways to put a unique ID number on a package of drugs besides RFID -- printed serial numbers on a lable, laser etching on the bottle, etc. There are IT pros and cons to each, obviously.

To the degree that some complain that the Pharma industry has been too slow to adopt RFID as a solution, the uncertainty about what the Secretary might adopt as the anti-counterfeiting technology standard will not speed RFID adoption along -- that's for certain.

The bigger issue though is that the US Congress, via legislation that has already passed the Senate, is making decisions that may dramatically shape the future of the RFID industry in this market -- facilitate it, direct it, or kill it.

And until I posted it on this blog site, no one in the industry seemed to notice. And they certainly are not organized to make their case to Congress about a preferred outcome that will benefit RFID adoption. Somebody is bending the Senate's ear about anti-counterfeiting technology for drugs -- and it's not the RFID crowd.

Remember this when Congress turns to food safety issues, or tracking hazardous chemicals, or facilitating product recalls, or debating personal authentication technologies for immigrants seeking jobs in the United States. Are those in the RFID space making their voices heard?

| Posted By RFIDblogger In Federal Legislation | Permalink | 0 Comments

Last week, the US Senate passed legislation that reauthorized the federal user fees on pharmaceuticals that help fund the FDA. Buried in the legislation was a provision -- posted earlier on this blog site -- authored by Senator Judd Gregg of New Hampshire, that would require Internet pharmacies selling to US citizens to use tracking technology to minimize the risk of counterfeiting.
An amendment to that language, offered by Senator Michael Enzi of Wyoming, legislates a specific technology solution - and it's not RFID. Indeed, it specifically excludes anti-counterfeiting technologies like RFID or barcodes that require readers, scanners or other devices to verify authenticity -- replacing the FDA's preferred tools with anti-counterfeiting technologies akin to those used on US currency.
This is yet another example of where those interested in RFID are missing the boat -- RFID providers are finding that other technology competitors are using the government process to exclude them from the pharma market. And those in the pharma space -- drug manufacturers, distributors, wholesalers, etc -- who have been spending time and money on RFID solutions may find that they need to accommodate two systems. RFID and this optical technology.

Get in the game, folks.

| Posted By RFIDblogger In Federal Legislation | Permalink | 6 Comments

The US Senate RFID Caucus held its first event of 2007 on Capitol Hill yesterday called "RFID and Innovation: America's Competitive Edge". RFID industry experts held a general discussion on what RFID is and how it is currently being used. The speakers chose to keep their topics broad, and did not delve too specifically into any of the particular public policy challenges that RFID technology faces today. In the audience were dozens of attendees, mostly from industry or industry representatives like lobbyists and government affairs people, but only a handful of Senate legislative staff.  Making future events tied to pending legislation or Federal policy decisions might make it more relevant to the target audience.

This event marked the first of four planned Senate RFID Caucus events for the calendar year 2007. Based on conversations with Senate staff, the next event will likely pertain to issues with RFID in the Healthcare sector. We are in communication with the Senate RFID Caucus and some of the trade associations involved in putting these events together. Feel free to pass on to us any ideas or topics you'd like to see addressed at the events.

| Posted By RFIDblogger In Federal Legislation | Permalink | 0 Comments

Senator Judd Gregg (R-NH) introduced federal legislation this week designed to improve the safety and security of drugs ordered over the Internet. The legislation is a response to concerns that bargain seeking drug customers are buying unsafe or counterfeit pharmaceuticals from unregulated and unscrupulous internet vendors. The overall legislation would set regulations for those Internet pharmacies that do business with customers in the United States, and require a license to dispense drugs to any person in the United States.

The legislation would amend Chapter V of the Federal Food, Drug, and Cosmetic Act. Among the requirements listed in the bill for those Internet pharmacies seeking a license to sell drugs to persons in the United States is this:

"The Internet pharmacy agrees to affix to each shipping container of drugs to be shipped in the United States such markings as the Secretary (of Health and Human Services) determines to be necessary to identify that the shipment is from a licensed Internet pharmacy, which may include anticounterfeiting or track-and-trace technologies."

Congress does plan to get involved in the question of whether and how RFID will be used in the pharmaceutical space. This is only the beginning of what I expect to be a busy legislative year on these questions. This legislation may get linked in the legislative process to the larger reauthorization of the Prescription Drug User Fee Act, which is considered "must-pass" legislation because it authorizes the collection of the fees that pay for the operations at the FDA.

| Posted By RFIDblogger In Federal Legislation | Permalink | 4 Comments

Last week the Senate marked up H.R. 5631, the Defense Appropriations Act for Fiscal Year 2007. The Senate report is not yet public, but we are aware of two congressional adds for RFID. The first is $1.0M for Navy to purchase RFID SMART containers. The second is $6.0M for the Army to continue its Active Data Rich RFID Technology Insertion and Enhancement Initiative. A third add, indirectly related to RFID is $10M for the Defense Logistics Agency received $10.0M for its Center for Supply Chain Management, which should have a significant impact on RFID policy.

| Posted By RFIDblogger In Federal Legislation | Permalink | 0 Comments

As this article from RFID Journal indicates, one of the key disputes in the patent litgation between Intermec and Alien is whether that court is the proper venue for hearing the dispute. Because there has been such growth in patent litigation, particularly in the IT sector, both Congress and the Patent and Trademark Office have been proposing significant changes in how patents are filed, reviewed, disputed and resolved. Taken together, the changes being proposed in Federal legislation represent the most sweeping changes in US patent law in decades. One of the more recent drafts of legislation in the House Judiciary Subcommittee on Courts and Intellectual Property includes language that would limit in which courts a patent case could be filed. Another bill gaining some momentum, from Congressman Darrell Issa (R-San Diego), would create a process where judges would self-select to be assigned complex patent cases. The intent is, over time, to develop judges with unique expertise in the rigors of a detailed, technical patent dispute -- since it can often be hard for courts to decifer the technology disputes at the core of these cases.

As the RFID industry grows, these patent disputes are likely to grow in number and importance. Companies should be watching how the PTO is changing the rules, and how Congress is getting involved. Both to understand how those changing rules might affect your future business strategy, and to determine whether the effect is significant enough to get involved. Other IT companies, pharmaceutical companies, biotechs, universities have been very engaged in the federal legislative effort -- the RFID industry has been nonexistent.

| Posted By RFIDblogger In Federal Legislation | Permalink | 1 Comments

Senators John Cornyn (R-TX) and Byron Dorgan (D-ND) have sent a letter to their colleagues announcing their intention to form an RFID Caucus.

There is a Senate Caucus for just about everything - a tourism caucus, a bicycle enthusiast caucus, etc. As such, a Caucus has no official function, authority or responsibility -- it is a way for Senators or Congressmen to identify to the public their particular interest in a topic. Usually it is driven by constituent interests in their state or district, but often is just a personal interest.

There has been discussion within both House and Senate for months about the creation of an RFID Caucus. The existing Internet Caucus in both the House and Senate had already done some RFID-related programs, allowing companies to showcase their technology and explain how it does or does not work. Some had an interest in trying to keep RFID-related issues within that context rather than as a separate Caucus of its own. Either way, the formation of the Caucus shows that your elected Representatives in Washington are becoming increasingly aware of RFID and its increasing role in the private and public sectors -- and intend to have something to say about it.

Those providing or using RFID services should see this as a wake up call that they have an opportunity to proactively help federal legislators adopt positive legislation that moves RFID forward, or risk responding to legislation as it plows ahead.

I will note that the Senate Republican High Tech Task Force was first out of the box with specific policy principles related to RFID. Here is their complete policy statement from March 2005, with the RFID segments bolded:

| Posted By RFIDblogger In Federal Legislation | Permalink | 0 Comments

According to National Journal's TechDaily (see excerpt below), Senator Hillary Clinton plans to introduce legislation that would prohibit the exchange of customer information without express intent from that consumer. While not targeted at RFID technology specificially, the degree to which RFID is used by financial services companies like Visa or Mastercard, or by retailers like Walmart and Home Depot -- RFID IT providers, data management software, and end users will all likely be covered by legislation like this. As the story in National Journal states, the yet-to-be introduced legislation will create a right to sue for monetary damages for "mishandled information". That definition could be key. As earlier stated in this blog, House Energy and Commerce Chaiman Barton will be introducing his own comprehensive privacy legislation very, very soon.
For those who believe that this is an opportunity to pre-empt state laws, there is no discussion in the article of any intention for this federal law to be anything other than a base-line federal privacy law. This effort will likely lead to more, not less, legislative activity on the privacy front by states.

| Posted By RFIDblogger In Federal Legislation | Permalink | 0 Comments

While agreeing to the request from the Department of Agriculture to fund a program to use RFID tags to identify and track animals -- like cows for Mad Cow Disease -- the House of Representatives passed legislation yesterday prohibitting any of the funds being used until Congress receives a comprehensive plan for how much money is ultimately needed and how it will be spent. Apparently, since the Dept. of Agriculture envisions having the tags scanned and entered into a private-sector controlled database, they have told Congress that they don't know exactly how much it will ultimately cost. Not a great answer. There also may need to be legislative changes to authorize certain elements of the RFID program -- changes that probably could and should have been done BEFORE trying to get the program rolled out. Oddly enough, Congress likes to have a say in how programs they are funding are operated.

A separate amendment was offered that would have removed funding for the program altogether -- not just blocking it pending a report to Congress. However, that amendment was defeated by a significant margin.

| Posted By RFIDblogger In Animal Identification , Federal Legislation | Permalink | 2 Comments

In reaction to recent mining incidents, where rescuers could not locate trapped miners, the US Senate is moving legislation updating the 1977 Federal Mine Safety and Health Act. The Committee on Health, Education, Labor and Pensions yesterday passed this bill.
The bill provides new initiatives of potential interest to providers of RFID and similar technologies, particularly requirements for tracking technologies for miners and communications capabilities. See the language below:

``(ii) POST ACCIDENT COMMUNICATIONS.--Not later than 3 years after the date of enactment of the Mine Improvement and New Emergency Response Act of 2006, a plan shall, to be approved, provide for post accident communication between underground and surface personnel via a wireless two-way medium, and provide for an electronic tracking system permitting surface personnel to determine the location of any persons trapped underground or set forth within the plan the reasons such provisions can not be adopted. Where such plan sets forth the reasons such provisions can not be adopted, the plan shall also set forth the operator's alternative means of compliance. Such alternative shall approximate, as closely as possible, the degree of functional utility and safety protection provided by the wireless two-way medium and tracking system referred to in this subpart."

The legislation also creates a grant program to develop, test, and deliver the kind of technology required above:

| Posted By RFIDblogger In Federal Legislation , Government Usage of RFID | Permalink | 1 Comments

The Department of Homeland Security's Data Privacy and Integrity Advisory Committee will be considering a report on the use of RFID in identification documents at its meeting June 7th in San Francisco. A draft of the report has been posted with a request for comments.

The report has already generated a little attention. This Government Computer News story overstates the tone of the report, but it's good.

From the DHS Privacy Committee Web site:

The Use of RFID for Human Identification (PDF, 15 pages - 127 KB) The DHS Emerging Applications and Technology Subcommittee of the Privacy Advisory Committee is seeking comments on this draft report. This report will be considered by the full Committee during the June 7, 2006 public Advisory Committee meeting in San Francisco, CA.

Please provide any comments in writing to privacycommittee@dhs.gov, by postal mail, or by fax by 12:00 p.m. EST on May 22, 2006. All Comments will be considered on an ongoing basis.

In other news, here's a blog posting drawing into doubt certain phone companies' denials that they participated in the NSA spying program.

I hope to see any S.F. Privacillites at the DHS Privacy Committee meeting. Those of you not in S.F. at that time, go ahead and be jealous of those of us who are.

Jim

Jim Harper (jim.harper@privacilla.org) is the Editor of Privacilla.org and Director of Information Policy Studies at the Cato Institute in Washington, D.C. (www.cato.org/tech). To subscribe, or unsubscribe from the Privacilla mailing list, just e-mail kindly saying which one you'd prefer. We're all friends here.

| Posted By RFIDblogger In Federal Legislation , Privacy | Permalink | 0 Comments