CyberWire Dispatch // Copyright (c) 1994 //

Jacking in from the "Regulations 'R' Us" Port:

Washington, DC -- The nascent electronic commerce and telemedicine industries are projected to be multi-billion markets, each helped along by the much hyped advances of the information superhighway.

Yet, it's easier to buy a parka from L.L. Bean via the Internet than it is for a cancer patient in Los Angeles to take advantage of breakthrough radiation treatment software located at the University of North Carolina.

And while electronic commerce is encouraged, legal and widely praised by no less the Head Techie of the U.S. -- Vice President Gore -- telemedicine is discouraged, illegal across state boundaries and its use systematically squashed by arcane Food and Drug Administration regulations.

Telemedicine is broadly defined as the delivery of medical services via a computer network. As long a such services operate within state boundaries, nobody much cares. It's when those life-saving bits stream from one state to another that state and federal authorities begin to wear black hats.

A recent study by the Council on Competitiveness said that legal and regulatory hurdles are keeping telemedicine applications from being broadly applied. Although several life-saving applications exist for telemedicine, "the full promise" of their use "has not be realized," the study says.

Only 2,000 telemedicine "consultations" took place last year, according to the Health Care Financing Administration, largely because of concerns arising from a cloudy legal and regulatory environment.

Interstate Telemedicine License

Because doctors need to be licensed in each state they practice, interstate telemedicine applications instantly run afoul of the law.

Unless the doctors are licensed in each state where the telemedicine application is taking place, the doctors open themselves to a host of malpractice and disciplinary actions.

And of course there isn't a nationwide, standardized licensing test for doctors. And to make sure the situation continues to be insane, the enlightened state of Kansas set a precedent recently by amending its licensing laws to target telemedicine applications by requiring a state license of any doctor "regardless of location."

FDA: "No-ing" the Code

The folks at UNC, using tax payer money, developed a world's first, world's only, software application that has been praised world wide as a breakthrough in radiation treatment for cancerous tumors.

Using computer modeling techniques, the software renders a 3-D image of the tumor and allows the doctor to precisely calculate the angle and dosage of radiation beams.

Doctors can precisely determine the best angle of the beam, which allows them to concentrate more radiation on the tumor and less on the "innocent" tissue nearby, greatly reducing any "collateral" damage.

Such an application saves time, saves surrounding tissue, hell, it might even save lives.

And as long as you're in North Carolina you can full take advantage of the software all you want. If you're out of state, well, you're fucked.

FDA regulations currently prohibit the use of the software anywhere else but in N.C. This means if you're a doctor in Wyoming or Los Angeles and are treating a cancer patient, you can't log into the UNC computers and run use the software to figure out a treatment.

However, you can log in and "play" with the software, you just better be damn sure you don't use anything you learn on a real live patient or you'll have the FDA enforcement police in your face.

The FDA is so ass-backwards on this one that they won't even allow a doctor to download the software and run it locally. Are you sensing a pattern here?

So, how did all this happen? I knew you'd ask...

The FDA says that such medical software is regulated just like medical devices. In other words, medical software has to run the same regulatory gauntlet that the makers of a heart valve or pacemaker have to endure.

When the developers of the UNC software tried earlier this year to put their software on the Internet for free downloading, the FDA informed the university that it considers distributors of such software to be "vendors" and therefore must adhere to regulations requiring pre-market approval. The university quickly yanked the code from its FTP site, fearing it would be punished.

And catch this. Because software is often tweaked and modified, every time a line of code changed, it would be susceptible to FDA approval processes all over again. And the lag times of the FDA approval process are legendary. We're talking major roadblocks here.

This regulatory morass is "so serious it could shut down all of telemedicine," said doctor Julian Rosenman, of the UNC Dept. of Oncology. The FDA "has decided that computer software that makes medical decisions is a medical device... and that means if we wanted to get our stuff out we would have to get FDA approval," he said.

Dr. Edward Chaney of UNC, one of the developers of the tumor modeling software, also adds that "the hardware issue cannot be overlooked." Current FDA policy calls for approval of "complete systems," he said. "Based on this policy it is conceivable that the FDA could consider an entire network to be a medical device if it were devoted to telemedicine."

In July, Chaney wrote the FDA a letter asking for clarification of the restrictions. "As you might imagine, we are deeply concerned about the implications for research and development of this apparent extension of FDA regulations," he wrote. The letter says his department is "confused about what we can and cannot do since the details of the official FDA position are unknown."

Chaney's letter asks six pointed questions, including wondering if the current restrictions prohibit distribution to foreign countries. And in two "freedom of speech" questions, he asked if the FDA would allow UNC to "publish the text of our source code in printed format" or place it in "read-only access" on their computers. "I'm anxious to see how they deal those two questions," he said.

And although the FDA hasn't officially responded to Chaney's now six month old letter, Dispatch has learned that the FDA Office of Compliance is working on a "preliminary reply," according to an FDA source in that office.

The proposal, based on answers to Chaney's letter, will indeed provide an exemption for software developed in an R&D environment to be used for telemedicine applications. The liability would rest with the end user.

The proposal, however, isn't being warmly received by the FDA legal hounds, who have yet to sign off on it. Any relaxing of the current regulations could be torpedoed on any level as it oozes through the FDA hierarchy.

A full draft proposal "probably won't hit the streets for six months," the FDA source said. Full approval could take more than a year.

Pass The Republicans, Please?

Somebody shake the Republicans out of their victory stupor and shove this situation under their nose.

House GOP Whip Tom DeLay of Texas announced this week the formation of "Project Relief," a new, non-congressional organization that is supposed to help the GOP leadership hancho its drive to thwart burdensome regulations that are hampering business and costing the economy money.

Federal regulations cost about $500 billion annually, DeLay said, or to about $10,000 for a family of four. Project Relief will be a coalition of business and other groups that will coordinate with Congressional actions to reduce regulations.

And Vice President Gore might step up to the plate on this, too. His reinventing government dog-and-pony show could use these clueless FDA regulations as its 1995 Regulatory Poster Boy.

Meeks out...