A group of law professors have petitioned the federal government, saying standards should be free if they are cited in a regulation. After all, free access to all kinds of information on the Internet is the norm, so, they argue, why can’t the same be true for standards? Currently, anyone can visit a government agency or library to simply read a standard. As for obtaining a copy, the federal government honors the intellectual property held by standards development organizations, and organizations or individuals who need to comply with a given standard (or are just curious) typically must buy it.
That was the crux of issue debated in an all day workshop hosted by the U.S. Office of Management and Budget (OMB) on May 15. AAMI leaders participated on two of the workshop panels.
The argument for free has a certain motherhood-and-apple-pie appeal. If I’m going to build a ladder and want to read the safety standard for ladders, shouldn’t I be entitled to read that standard on the Internet for free, right there with Wikipedia, pirated CD downloads, and all of the other “free” intellectual property that magically appears on the web?
As AAMI’s CEO, I was on a panel of primarily standards development organizations. My main point was there is no such thing as free. Standards are a much better alternative to regulations, for all of us. Products are better and safer because of standards. They aren’t free. In fact, their development is quite expensive.
Eamonn Hoxey, vice president of regulatory compliance, medical devices, and diagnostics for Johnson & Johnson and a member of the AAMI Board of Directors and Executive Committee, participated on a panel of primarily private sector organizations that participate in standards development. Panel members consistently conveyed the important point that manufacturers participate in standards development because they believe it make products safer. They also reminded the audience that the cost of purchasing a standard is a drop in the bucket compared with the cost of participation and compliance with the standards.
Elisabeth George, vice president of global government affairs, regulations and standards, for Philips Healthcare, also participated in the workshop for AAMI. She noted that Philips believes their involvement in standards development is “key to assurance of safe and effective medical solutions for all of our products.”
Major medical device companies who agree with Philips and Johnson & Johnson that good standards make products safer pay the overwhelming cost of standards development for the entire industry—and for all of healthcare, for that matter. Their fees support the infrastructure for standards development. AAMI helps supplement industry support by selling standards very inexpensively compared to the actual cost or the value of the information.
If standards used in regulations must be given out like free candy at the July 4th parade, who is going to subsidize that? In our case, it could be the federal government (taxes) or AAMI members (higher dues, higher fees). The costs would not go away. They simply would be shifted.
Stay tuned. The OMB will analyze all of the written comments submitted and oral remarks made. These law professors who feel the need for free standards or a big win—or who simply want to make a point for the sake of making a point—are not going to take their marbles and go home.