You medical records, not so private

[Guest guest]

New federal medical privacy regulations, touted by the

Clinton administration as a landmark of patient protection,

will for the first time explicitly permit doctors,

hospitals, other health services and some of their business

associates to use personal health records for marketing and

fundraising.

The rules were included in the federal regulations after a

months-long public relations effort by the industry. Under

the exemptions, doctors, clinics, hospitals and others that

normally have access to medical records -- along with

business associates working under contract with them -- will

be allowed to send out individualized health information and

product promotions.

A pregnant woman, for instance, could receive pitches about

vitamins or infant health-care products. A patient who has

been treated for sexually transmitted diseases could receive

telemarketing calls offering condoms or new medicines.

The exemptions also give foundations affiliated with

hospitals continued access to patient names, ages, addresses

and telephone numbers for fundraising initiatives. Such

foundations raise billions of dollars annually by soliciting

patients and their families at medical facilities and at

their homes.

Officials of the Department of Health and Human Services,

the White House and some patient advocates said the new

privacy regulations announced Dec. 20 stand as an important

new bulwark against the misuse of patient information,

notwithstanding the exemptions.

When the rules fully take effect in two years, proponents

said, patients will have a new right to access their own

records; employers will be prohibited from receiving

personal health data, except for the administration of

health plans; and people who misuse private medical records,

such as selling them, could face fines or prison.

In addition, any health-care provider or service that uses

medical records will have to notify patients how they're

doing so. Patients also will have the option of saying no to

marketing or fundraising -- but only after they have been

contacted at least once by a given entity.

Claxton, deputy assistant secretary for health policy

at HHS, said the department deftly handled the complex task

of protecting medical records while encouraging the flow of

information to improve patient care.

" It's the best we could do and we think we did a good job, "

he said. " There's going to be a lot of discussion as this is

implemented. If changes need to be made, they should be

made. "

But consumer advocates and privacy specialists worry the

exemptions will undermine the spirit of the rules and spur

the use of confidential records for marketing by

specifically allowing activity that in the past was often

constrained by ethical or business concerns.

Among other things, the regulations will permit pharmacies

to share patients' prescription records with business

associates to target patients with letters reminding them to

take medicine, or to send them " educational materials "

sponsored by drugmakers.

That sort of arrangement created a storm of controversy

three years ago when it became public that CVS Corp., Giant

Food Inc. and other pharmacies shared prescription

information with a data-management company called Elensys

for targeted mailings. CVS and Giant canceled the programs

after customers complained.

The new marketing and fundraising rules have " exploded the

old notions of medical confidentiality and privacy, " said

Murray, a medical ethicist.

" Your medical record was meant for your medical care, " said

Murray, president of the Hastings Center, a medical ethics

research center in New York. " Now your medical record

becomes a marketing tool. "

Supporters of the new rules note that health-care providers

now will have to determine that products provide a health

benefit before making a contact with a patient. When

contacting a patient, marketers and fundraisers will have to

disclose the source of personal information, describe their

financial benefit and explain why the individual was

targeted for a promotion, officials said.

Critics say that while patients will be allowed to say no to

promotions after being contacted, they will have to reach

out to each entity that has contacted them to exercise that

right.

" The rules are filled with virtual rights: You reach for

them and they're often not there, " said Gellman, a

lawyer and privacy consultant in the District, who has

studied the regulations. " This authorizes a kind of behavior

that was once viewed as unethical or improper. "

Claxton, the HHS official, said officials faced the

challenge of distinguishing between educational material

about products and services that improve health, and

marketing promotions sponsored by drug companies and others.

Because the department concluded that getting health

information to patients was so important, officials decided

to be more flexible on the issue of marketing than the draft

released in 1999, as long as health-care providers meet

guidelines for disclosure and give patients the ability to

opt out, among other things.

" What is communication for health care, and what is

marketing? Sometimes they're the same thing, " Claxton said,

adding that department officials believe that doctors,

hospitals and others still will be constrained from doing

anything that might offend patients.

Claxton said industry pressure played no role in the

decision to include exemptions for marketing and

fundraising. He said he maintained contact with some key

groups that supported the changes as part of the normal

regulatory process. Those groups included the American

Hospital Association, the Association for Healthcare

Philanthropy, pharmacy benefit managers, insurers and

consumers.

The company that worked with CVS and Giant, now known as

Adheris, urged regulators in comments on the draft proposal

not to require pharmacies to get " prior authorization " from

patients to use prescription information for targeted

mailings.

Industry leaders acknowledged pressing for changes to the

draft regulation, which would have proscribed many

fundraising and marketing initiatives allowed under the

final rules. Among the most aggressive groups was the

Association for Healthcare Philanthropy. Its members raised

nearly $6 billion in fiscal 1998 for construction projects,

to buy equipment, run programs and so on.

The group wrote letters to HHS, met several times with

regulators and as recently as December participated in

conference calls with them to clarify issues. They turned to

Rep. Ellen Tauscher (D-Calif.), among others on Capitol

Hill, saying a staffer called HHS officials on their behalf.

The association became so aggressive about the issue that

department officials told it to tone things down, according

to officials in the department and the group. " We stopped

doing that because HHS said, 'Hey, we got it. We got your

message,' " said C. McGinly, the association's

president and chief executive.

In the end, they got what they wanted -- access to patient

information without having to get permission from patients

first. " AHP Announces VICTORY! Patient Privacy Regs

Favorable to Health Care Philanthropy, " said the group's

press release.

" By pulling together a public relations specialist, a

lobbying expert, writers and others to analyze the draft

regs, comment, communicate to the press, meet and educate

the staff and members of key Congressional committees and

others, we were able to see that AHP was heard on this

issue, " the press release said.

The provisions don't sit well with critics, who contend that

patients ought to have a right to say no upfront to uses of

their medical records that do not have a direct bearing on

health care. Some critics also may be urging states to write

tougher rules of their own.

" Once they have open access, where else does it go? It is

too big a loophole, " said Sen. J. Leahy (D-Vt.), who

may pursue legislation on the matter. " In the digital age,

any loophole is bigger than it looks. "

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