(CWD) FDA Foils Telemedicine Advances

[David Farber <farber () central cis upenn edu>]

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...