[Med-privacy] Hopkins seeks patient waiver of privacy rule--errors fixed

[DPeelMD@aol.com]

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<A HREF=3D"http://www.sunspot.net/news/local/bal-md.privacy06jul06.story">ht=
tp://www.sunspot.net/news/local/bal-md.privacy06jul06.story</A>=20
Hopkins seeks patient waiver of privacy rule

Proposal would allow researchers to see files to recruit for clinical trials=
;=20
Plan needs government approval; Opponents call request too broad, and say it=
=20
would create confusion
By Julie Bell
Sun Staff
July 6, 2003

<A HREF=3D"http://www.jhu.edu/www/medicine">Johns Hopkins Medicine</A> wants=
 to ask all its patients to waive certain privacy=20
rights so researchers can comb through their medical records, hunting for=20
people they can invite to enroll in clinical trials.=20

The university called its proposal, which is subject to federal approval, a=20
straightforward attempt to balance patients' rights under a new medical priv=
acy=20
law with researchers' need to find volunteers for human tests of drugs and=20
devices.=20

"If we [could say], 'You're here at Johns Hopkins, can we call you about any=
=20
study at Johns Hopkins?' that's what we want to do," said Joanne Pollak, a=20
Hopkins Medicine vice president and general counsel.=20

But privacy advocates say the Hopkins proposal is overly broad and could=20
confuse patients at a vulnerable time in their lives.=20

If the U.S. Department of Health and Human Services approves, Hopkins will=20
ask every incoming patient to sign a form granting researchers blanket appro=
val=20
to look at their records. Patients who decline still would be treated, but=20
their records would be tagged so that researchers could not review them with=
out=20
explicit permission.=20

The Hopkins proposal comes as researchers nationwide grapple with finding=20
patients for clinical trials without running afoul of the Health Insurance=20
Portability and Accountability Act, which took effect April 14.=20

Researchers openly recruit test subjects by advertising or by asking=20
physicians to refer their patients. But they have also found subjects by com=
bing=20
hospital records without patients' knowledge -- a practice the new law allow=
s under=20
special circumstances.=20

They may, for example, look at patient records if a university oversight=20
panel determines it is impractical to ask permission first. Hopkins and the=20=
<A HREF=3D"http://www.sunspot.net/templates/misc/'http://www.sunspot.net/ent=
ertainment/visitor/college/bal-hl-umb.story">
University of Maryland, Baltimore</A> use this method -- though Maryland say=
s it does so=20
sparingly.=20

At Duke University, researchers are merely required to notify an oversight=20
panel before looking at inpatient medical records.=20

The new privacy regulations are a critical part of the accountability act,=20
which Congress enacted in 1996 to allow patients to switch jobs without losi=
ng=20
health insurance. The law allows doctors, hospitals and insurers to share=20
medical information needed for treatment and billing but generally gives pat=
ients=20
control over other uses.=20

So far, Health and Human Services has received about 600 complaints alleging=
=20
violations of the privacy law, department spokesman Bill Pierce said.=20

In a May 20 letter to federal privacy policy official Susan McAndrew, Pollak=
=20
said Hopkins believes that its proposal for a blanket approval form is=20
preferable to "the confusing maze of rules applicable to recruitment for cli=
nical=20
trials."=20

It also would prevent situations in which patients are unnerved by=20
researchers who want to recruit them for a trial based on medical conditions=
 they=20
thought were private.=20

"People are offended," Pollak said of the current practice. But some worry=20
that Hopkins' solution would add to the confusing load of paperwork patients=
=20
must review before they're treated, leading them to sign without realizing w=
hat=20
the form permits.=20

"You're going to ask patients at a very vulnerable time to waive their=20
rights," said Mark Rothstein, director of the Institute for Bioethics, Healt=
h Policy=20
and Law at the University of Louisville.=20

Others say Hopkins' request is overly broad, violating the spirit of a law=20
designed to limit disclosure of medical information and inform patients of=20
exactly who gets their health information and why.=20

The proposed form seems to be saying, "We're asking permission to look at=20
your entire file for whatever study we're thinking about doing," said Kathar=
ina=20
Kopp, program manager for the Health Privacy Project, a Washington-based=20
nonprofit organization that backed passage of the privacy law. "We don't wan=
t to=20
stop research, ... but the authorization is way too broad."=20

Still, Kopp said Hopkins' intentions are good because "they're trying to=20
raise awareness and get authorization upfront."=20

Joy Pritts, an assistant research professor at Georgetown University's Healt=
h=20
Policy Institute, agreed, saying that Hopkins' form goes beyond what the=20
privacy rule requires. "From a patient's perspective, clearly they would pre=
fer to=20
be contacted in advance," she said.=20

But Kathy Schaefer of Baltimore, who once volunteered for a Hopkins clinical=
=20
trial involving osteoporosis, isn't impressed with the proposal. She said sh=
e=20
prefers other methods of recruiting clinical trial volunteers, such as askin=
g=20
doctors to refer their patients.=20

Even if she did sign a blanket waiver form, she said, "I would find it=20
intrusive. I really would."=20

Copyright =A9 2003, <A HREF=3D"http://www.sunspot.net/">The Baltimore Sun</A=
>    =20























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ivacy06jul06.story">http://www.sunspot.net/news/local/bal-md.privacy06jul06.=
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<B>Hopkins seeks patient waiver of privacy rule<BR>
</FONT><FONT  COLOR=3D"#000000" style=3D"BACKGROUND-COLOR: #ffffff" SIZE=3D5=
 FAMILY=3D"SANSSERIF" FACE=3D"Arial" LANG=3D"0"></B><BR>
<B>Proposal would allow researchers to see files to recruit for clinical tri=
als; Plan needs government approval; Opponents call request too broad, and s=
ay it would create confusion</FONT><FONT  COLOR=3D"#000000" style=3D"BACKGRO=
UND-COLOR: #ffffff" SIZE=3D2 FAMILY=3D"SANSSERIF" FACE=3D"Arial" LANG=3D"0">=
</B><BR>
By Julie Bell<BR>
Sun Staff<BR>
July 6, 2003<BR>
<BR>
<A HREF=3D"http://www.jhu.edu/www/medicine">Johns Hopkins Medicine</A> wants=
 to ask all its patients to waive certain privacy rights so researchers can=20=
comb through their medical records, hunting for people they can invite to en=
roll in clinical trials. <BR>
<BR>
The university called its proposal, which is subject to federal approval, a=20=
straightforward attempt to balance patients' rights under a new medical priv=
acy law with researchers' need to find volunteers for human tests of drugs a=
nd devices. <BR>
<BR>
"If we [could say], 'You're here at Johns Hopkins, can we call you about any=
 study at Johns Hopkins?' that's what we want to do," said Joanne Pollak, a=20=
Hopkins Medicine vice president and general counsel. <BR>
<BR>
But privacy advocates say the Hopkins proposal is overly broad and could con=
fuse patients at a vulnerable time in their lives. <BR>
<BR>
If the U.S. Department of Health and Human Services approves, Hopkins will a=
sk every incoming patient to sign a form granting researchers blanket approv=
al to look at their records. Patients who decline still would be treated, bu=
t their records would be tagged so that researchers could not review them wi=
thout explicit permission. <BR>
<BR>
The Hopkins proposal comes as researchers nationwide grapple with finding pa=
tients for clinical trials without running afoul of the Health Insurance Por=
tability and Accountability Act, which took effect April 14. <BR>
<BR>
Researchers openly recruit test subjects by advertising or by asking physici=
ans to refer their patients. But they have also found subjects by combing ho=
spital records without patients' knowledge -- a practice the new law allows=20=
under special circumstances. <BR>
<BR>
They may, for example, look at patient records if a university oversight pan=
el determines it is impractical to ask permission first. Hopkins and the <A=20=
HREF=3D"http://www.sunspot.net/templates/misc/'http://www.sunspot.net/entert=
ainment/visitor/college/bal-hl-umb.story">University of Maryland, Baltimore<=
/A> use this method -- though Maryland says it does so sparingly. <BR>
<BR>
At Duke University, researchers are merely required to notify an oversight p=
anel before looking at inpatient medical records. <BR>
<BR>
The new privacy regulations are a critical part of the accountability act, w=
hich Congress enacted in 1996 to allow patients to switch jobs without losin=
g health insurance. The law allows doctors, hospitals and insurers to share=20=
medical information needed for treatment and billing but generally gives pat=
ients control over other uses. <BR>
<BR>
So far, Health and Human Services has received about 600 complaints alleging=
 violations of the privacy law, department spokesman Bill Pierce said. <BR>
<BR>
In a May 20 letter to federal privacy policy official Susan McAndrew, Pollak=
 said Hopkins believes that its proposal for a blanket approval form is pref=
erable to "the confusing maze of rules applicable to recruitment for clinica=
l trials." <BR>
<BR>
It also would prevent situations in which patients are unnerved by researche=
rs who want to recruit them for a trial based on medical conditions they tho=
ught were private. <BR>
<BR>
"People are offended," Pollak said of the current practice. But some worry t=
hat Hopkins' solution would add to the confusing load of paperwork patients=20=
must review before they're treated, leading them to sign without realizing w=
hat the form permits. <BR>
<BR>
"You're going to ask patients at a very vulnerable time to waive their right=
s," said Mark Rothstein, director of the Institute for Bioethics, Health Pol=
icy and Law at the University of Louisville. <BR>
<BR>
Others say Hopkins' request is overly broad, violating the spirit of a law d=
esigned to limit disclosure of medical information and inform patients of ex=
actly who gets their health information and why. <BR>
<BR>
The proposed form seems to be saying, "We're asking permission to look at yo=
ur entire file for whatever study we're thinking about doing," said Katharin=
a Kopp, program manager for the Health Privacy Project, a Washington-based n=
onprofit organization that backed passage of the privacy law. "We don't want=
 to stop research, ... but the authorization is way too broad." <BR>
<BR>
Still, Kopp said Hopkins' intentions are good because "they're trying to rai=
se awareness and get authorization upfront." <BR>
<BR>
Joy Pritts, an assistant research professor at Georgetown University's Healt=
h Policy Institute, agreed, saying that Hopkins' form goes beyond what the p=
rivacy rule requires. "From a patient's perspective, clearly they would pref=
er to be contacted in advance," she said. <BR>
<BR>
But Kathy Schaefer of Baltimore, who once volunteered for a Hopkins clinical=
 trial involving osteoporosis, isn't impressed with the proposal. She said s=
he prefers other methods of recruiting clinical trial volunteers, such as as=
king doctors to refer their patients. <BR>
<BR>
Even if she did sign a blanket waiver form, she said, "I would find it intru=
sive. I really would." <BR>
<BR>
Copyright =A9 2003, <A HREF=3D"http://www.sunspot.net/">The Baltimore Sun</A=
>     <BR>
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