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Private lives, public concerns

Safeguards for patient data take on a new urgency as HIPAA’s impact becomes apparent.

A patient’s chart can be many things. It is a compendium of ailments and treatments, but it is also a life story, full of clues to a patient’s state of mind, love life and financial status. In settings such as the Yale-New Haven Hospital and the School of Medicine, this window into a person’s life is open to physicians, nurses, medical students, residents, clerical workers, pharmacists and others who might need access to it. Now the long-awaited implementation of a 1996 law requires that all health care workers privy to a patient’s personal information be trained in protecting confidentiality.

The Health Insurance Portability and Accountability Act, or HIPAA, requires health care professionals to protect privacy and create standards for electronic transfers of health data. The Office for Civil Rights at the Department of Health and Human Services will enforce the regulations and impose penalties on institutions that do not make a good-faith effort on privacy and security. The deadline for university compliance is April 13, 2003. Electronic exchange standards will be required six months later.

Horror stories of people being denied jobs and loans because of their health status prompted Congress to pass the law in 1996. Also looming was the prospect of genetic discrimination given the possibility that one’s genes might be predictors of disease (See “Tailor-Made Medicines Are Within Our Reach”). “There is no question that legislation ensuring the right of privacy to medical information is necessary,” said Jed M. Shivers, M.B.A., deputy chief operating officer of the Yale School of Medicine and a member of the university’s executive steering committee on HIPAA compliance. The most pernicious abuses regarding privacy stemmed from the sale of information by insurance firms or others. But leaks of personal data also occur due to carelessness. For example, Shivers pointed out that staff can no longer discuss cases while another patient is in the room. Patient and drug names, which might provide hints of specific ailments, may no longer be listed on receipts. “Our strategy is to create a strong network, make the system locked down and have information take the appropriate path,” Shivers said. Faculty will trained to secure data on computers and portable devices with passwords, automatic locking screensavers and other tools.

“This is an opportunity to do the right thing and become more efficient by automating the processes that should be automated,” said Susan E. Grajek, Ph.D., director of communications and technical support for the medical school’s information technology service, ITS-Med.

The regulations are still evolving, but they require most medical providers to obtain a patient’s written consent before disclosing information; institutions must hold onto the consent forms for six years. “The concept sounds basic and straightforward, but there are hundreds of pages of complicated regulations,” said Julie Behm Carter, J.D., associate general counsel for Yale.

The biggest changes will be in terms of education and awareness, according to David Stagg, Ph.D., director of Systems Engineering and Security for ITS-Med and a research scientist in pharmacology. Care will be taken to keep records private, from simple matters such as not leaving faxes exposed on a desk to installing encryption tools on computers.

The university is surveying more than 5,500 people, including employees, postdocs and other fellows, researchers and volunteers, to determine how and where records are stored, how many people must be trained and how protected information is used. Shivers expects everyone at the School of Medicine to undergo some training on an interactive website. Training is on hold while the government modifies the rules. Grajek does not expect the Web-based training sessions to last more than 90 minutes. “I’m optimistic that HIPAA won’t be overwhelming,” said Grajek, who also coordinated preparations for Y2K conversion at the medical school. “People must take HIPAA seriously, but there will be minimal disruption.”

Shivers noted that the law is not perfect and will continue to evolve as institutions adapt. Already, the government has eased regulations about research and sharing knowledge with medical students.

“This will be an ongoing effort,” said Janet E. Lindner, a project manager in the office of the vice president of finance and administration, who will organize implementation of HIPAA at Yale. “But people throughout the university are working together as a project team on a goal we all care about.”

Smallpox vaccination study places administration’s plans for terror response in doubt

In the aftermath of September 11, Yale public health specialist Edward H. Kaplan, Ph.D., started thinking about how to fight bioterrorism. The result was a study on smallpox vaccination that made national headlines, in no small part because it criticized federal government terror reaction plans as being too little, too late.

Using a mathematical model, Kaplan found mass vaccination of the population in the area of an outbreak to be far more effective than “ring vaccination,” the limited immunization strategy the government first recommended as the initial response to a smallpox attack. He published his study in the Proceedings of the National Academy of Sciences in July, shortly after the Bush Administration announced its policy.

Working with MIT colleagues David L. Craft, M.S., and Lawrence M. Wein, Ph.D., Kaplan used their model to analyze how different vaccination strategies contain the spread of a smallpox attack that infects 1,000 people in a large city. Their study took key features of guidelines from the Centers for Disease Control and Prevention (CDC) and applied them to a disease transmission model. The least effective method was ring vaccination, which isolates the infected and vaccinates people found to be in close contact with them. Ring vaccination would allow 367,000 cases of smallpox and 110,000 deaths and would take 350 days to end the outbreak.

By contrast, a mass vaccination begun as soon as authorities learned of the attack would result in 1,830 cases and 560 deaths and end the outbreak in 115 days. (It takes two weeks for smallpox to incubate and for symptoms to appear.) The analysis found that switching from ring to mass vaccination on the 33rd day of a crisis would still allow 15,570 cases and 4,680 deaths.

Before smallpox was eradicated in 1980, ring vaccination was the accepted strategy, because cases were isolated and most people had been immunized. Throughout the history of the disease, the government has been reluctant to undertake mass vaccination, since the vaccine uses a live virus that can cause severe side effects and even death. Still, Kaplan said the fatality risk of mass vaccination—about one person in 1 million—is minuscule compared to the possible death toll of a terror attack.

As Yale Medicine went to press in October, the CDC director, Julie L. Gerberding, M.D., M.P.H., and other top bioterrorism officials announced a change in strategy away from ring vaccination, recommending instead that voluntary immunization begin immediately for 1 million military personnel, followed by 10.5 million health care workers and emergency responders. The vaccine would then be offered to the public, most likely in early 2004. As President Bush considered the proposal, physician organizations including the American Medical Association and the American Academy of Pediatrics (AAP) urged caution and a continued policy of ring vaccination.

“The [recommendation] is flexible and could change if there is an actual outbreak of smallpox, or if a safer vaccine becomes available,” said Robert S. Baltimore, M.D., professor of pediatrics and epidemiology at Yale and lead author of the AAP’s policy statement.

Kaplan has found himself in political territory before. His landmark work on the New Haven needle exchange program led some to label him an activist for AIDS patients and drug addicts. But Kaplan rejects any notion that his research has a political dimension. “Many if not most would consider the needle exchange results to come from the political left and the smallpox results to come from the political right,” he said. “The truth is, in both cases, the results came from reasoned analysis.”

Tailor-made medicines are within our reach, Collins tells genomics conference

Within two decades a new generation of highly effective designer drugs will spring from our improved understanding of the human genome, according to the director of the National Human Genome Research Institute, Francis S. Collins, M.D., Ph.D. ’74, FW ’84.

As scientists delve more deeply into the human genome, they are developing faster and cheaper techniques to identify individual genetic variations, Collins told the audience attending the fifth annual Pharmacogenetics and Medicine Lectures sponsored by Genaissance Pharmaceuticals in Harkness Auditorium in June. Locating these genetic polymorphisms is crucial to making drugs more effective and preventing harm, because genetic differences lead to different drug responses. Collins believes that by about 2010 information about individual variability will allow doctors to choose medications that best fit the individual’s genetic makeup. “Doctors will have to get used to determining the genotype before writing the prescription,” said Collins, who earned his doctorate in physical chemistry and did a postdoctoral fellowship in genetics at Yale.

Identifying variation is still painstaking, he said, because “the genome is a big place.” Searching for polymorphisms by typing the whole genome for each individual in a study is too slow and far too expensive to be practical, even at the current cost of 50 cents per genotype, said Collins. If an individual’s genome contains about 10 million places where variations are likely (out of 3 billion base pairs), then scanning each genome for the most common variation for a sample of 1,000 people with a disease and 1,000 controls would cost $10 billion.

Researchers are developing shortcuts. One explores the relationship between variants in the genome and their neighbors. Once such a “haplotype map” is developed, this method would reduce the number of variants that have to be tested by a factor of about 40. Another promising shortcut for identifying disease-linked polymorphisms is to pool DNA samples from a large number of individuals, then compare the pooled genomes of people with a disease with the pooled genomes of controls. In Collins’ lab at the NIH, this pooling method has proven accurate to within 3 percent and is far cheaper than analyzing each individual’s genome separately. Collins estimated that a combination of the haplotype map, the pooling method and an anticipated drop in the cost of genotyping would put the price of a study of 1,000 affected people and an equal number of controls at about $50,000.

Given the public’s concern about potential misuse of genetic information, Collins said the nation urgently needs laws barring genetic discrimination and urged audience members to get involved in this debate. He predicted that primary care providers, especially nurses, would play a critical role in educating and counseling patients about how their health care might be affected by advances in human genetics.

A list of links to websites on the human genome can be found at www.genome.gov and also at www.nchpeg.org/resources/resources.asp. A free poster of the genome is available from http://public.ornl.gov/hgmis/external/poster_request.cfm. The site also has a guide for accessing and using the gene, protein and genetic disorder databases.

Magazine gives students an outlet for creative work and a way to “unpack experiences”

Second-year M.D./Ph.D. student Kumar Narayanan recognizes that “not a lot of emotional experience in medicine is talked about. Part of being a professional is building a little bit of a wall between you and a patient … and that’s not a bad thing.” But Narayanan still feels a need to “unpack experiences,” and he does this, in part, by writing. “Putting it down on paper or on a computer screen is a way to make something intractable, tangible. That’s the first step for me in engaging the experience.”

Narayanan’s “Reflections,” describing his evolving feelings as he performs a human dissection, is one of 28 poems, stories and personal essays (along with drawings and photographs) published earlier this year in Scope: The Yale Health Professions Literary Magazine.

Editor Ilene Wong, a third-year medical student, found the inspiration to revive the medical school’s on-again, off-again literary magazine while taking part in a writing seminar led by author and retired surgeon Richard Selzer, M.D., HS ’61. It is her hope, Wong said, that Scope will expand the community of writers the seminar has created. Reading the work of colleagues can “make people realize there are other people [writing] out there” and convey the message that “you can support and pursue your literary goals in a medical setting.”

Selzer thinks his bimonthly workshop for a dozen students accomplishes that. Students “are overwhelmed with the new technology and this distancing of the caregiver from the patient. I am reminding them that there is a whole world of literature and humanities that they can bring to bear upon their contact with the sick,” said Selzer, whose 10 books include Confessions of a Knife and Letters to a Young Doctor. “The students love it. They want to write. … I want them to be a generation of writing doctors that come after me.”

One story in the magazine describes a young doctor confronting a belligerent patient. Another meditates on a grandmother’s illness in light of a medical student’s expanding knowledge of pathology. A poem describes the use of an insulin needle to inflate worms for use as fish bait. Much of the work came from medical students, but contributors also include residents, nursing and public health students and a faculty member. Funding to print 150 copies of Scope came from the Office of Student Affairs, the Department of Internal Medicine and the Program for Humanities in Medicine.

“I was happy that people were writing and were willing to send something in,” Wong said. “I think it’s gutsy to send something into an unknown venue. It’s an act of vulnerability.”

Two M.D./Ph.D. students plan to publish another issue of Scope in the spring. They are Eyal Kimchi, a second-year student who helped with editing and layout, and classmate Jena Giltnane.

Assistant dean leaves Yale for a post at Cornell’s new medical college in the Persian Gulf

In her 13 years at Yale in various posts, Cynthia A. Andrien, M.S., has seemingly done it all. She’s been the bearer of glad, and sad, tidings every March at Match Day, the cheerleader for a charity football game, counselor and advisor to students, a source of information and, at times, a shoulder to cry on.

In August Andrien, the assistant dean for student affairs, left Yale for Cornell. But rather than hop Metro-North to New York City, she flew to Qatar, an oil-rich monarchy in the Persian Gulf. She started in September as associate dean for admissions and student affairs at the new Weill Cornell Medical College in Qatar, a joint project of Cornell and the Qatar Foundation for Education, Science and Community Development. The school will offer a six-year program; two years of premed followed by four years of medical education. The inaugural premed class entered this fall; the first medical school class will enter in 2004.

Andrien, the former registrar who started at Yale as administrative assistant to then-Associate Dean for Student Affairs Robert H. Gifford, M.D., HS ’67, was approached earlier this year by a headhunting firm. She said several factors about the job intrigued her. There was “the opportunity of developing a program from square one,” she said, and the excitement and exoticism of “working in a very different culture, living in a different area, being able to travel and experience other parts of the world.”

The decision was not an easy one. Her husband, Steve, a sales representative for a company that markets class rings, will stay in Connecticut, at least for a while, she said, although she’ll be able to visit every eight weeks. Andrien said she’ll also miss the students. “At commencement, as the students were going by, I was feeling so torn and sad,” she said. “But I kept thinking, ‘They move on so it’s OK if I move on.’ ”

It may strike some as a particularly difficult and dangerous time to be taking on a job in as volatile a region as the Middle East, but after a long weekend in Doha in June, Andrien found the country reassuring. “I felt very safe there,” she said, noting that she’ll live in a housing complex for international workers.

Qatar is a Connecticut-sized patch of desert on a peninsula that juts out into the Persian Gulf from its only land border, with Saudi Arabia. The country has a progressive administration that allows women to drive and doesn’t require them to cover their faces. Andrien expects 70 percent of the school’s first premed class to be women. “If women were not treated well I would not have taken the job,” she said. “My key role is to be working with the students and counseling them academically, careerwise and somewhat personally.”

That personal touch is what has endeared her to hundreds of medical students, as well as the medical school faculty. “You have made a big university feel like a community,” said Richard Belitsky, M.D., associate clinical professor of psychiatry, one of the speakers at a farewell reception in July.

“She has this amazing ability to make you feel like you’re so special,” said Kavita Mariwalla, a third-year student. “She makes you feel like she is giving you her undivided attention.”

Nancy R. Angoff, M.P.H. ’81, M.D. ’90, HS ’93, admitted that her first thoughts on hearing of Andrien’s leaving were selfish. “What am I going to do?” she asked herself. Then another thought came to Angoff. “The students in Qatar are the most fortunate medical students in the world right now.”

Executive of firm that cloned human embryos argues the research should continue

The future of therapeutic cloning rests on shaky ground as legislators contemplate new laws that would make it a crime not only to clone human embryos, but to use any products derived from such cloning. As Robert P. Lanza, M.D., vice president of medical and scientific development at Advanced Cell Technology (ACT), told a Yale audience in May, “we could go to jail for 10 years and be fined $1 million if pending legislation is enacted.”

ACT hit the front pages late last year when it reported having cloned human embryos in hopes of harvesting stem cells for research, although the embryos grew for only a few hours to between four and six cells. The company has been at the forefront of research into technologies of genetic manipulation, restoring youth to aging cow cells, creating biodegradable scaffolding for replacement tissue and using animal cells to develop organs for xenotransplantation.

Yet research into such potential therapies is threatened, Lanza said at “The Future of Therapeutic Cloning,” a symposium sponsored by the Yale Bioethics Project. In his keynote talk, he said about 80,000 people are awaiting donor organs, yet only 20,000 will undergo transplants. “For many patients, their only hope of survival is the hope of getting a donor organ,” he said. “With the advent of cloning, we have a new technology at our disposal that might allow us to eliminate this problem of organ shortage as well as that of immunosuppressive therapy.”

The prospect of cloning human embryos to harvest their stem cells has been swept up in the ongoing national debate over abortion. Those stem cells can, theoretically, be prodded to differentiate into virtually any human tissue. But the embryos from which they are derived are destroyed in the process, an act anathema to abortion opponents. “There will never be federal money for this work,” Lanza told an audience in Luce Hall in May. “The debate now is whether they are going to let anyone do it.” Should the so-called Brownback Bill that has been pending before the Senate since the fall of 2001 be passed, Lanza said, cloning of human embryos for any purpose, reproductive or therapeutic, would become a crime.

After Lanza’s talk, two panels of Yale ethicists, physicians and lawyers discussed the social, medical and moral implications of cloning and stem cell research. Science is pitted against “very strongly felt moral and ethical feelings,” said panelist Myron Genel, M.D., professor of pediatrics. “The scientific community, at least reflected by statements of our most prestigious organizations, is virtually unanimous that this research should go on.”

Lanza noted that before ACT published its report of cloning a human embryo in November 2001, a poll found 90 percent of the public opposed to human cloning, both therapeutic and reproductive. “There was no distinction between the applications,” he said. But within two weeks a CNN/USA Today/Gallup poll reported that 54 percent of the public supported cloning for medical purposes. “At last people are starting to understand that there is the kind of cloning to make babies and the kind of cloning to treat human disease,” Lanza said.

“People have different opinions as to the moral value of this entity,” said Lanza, referring to cloned embryos. “This isn’t an academic question. There are literally tens of millions of people out there who could benefit.”

For some in public health, changes to chicken have been foul deeds, indeed

The role of chicken in the American diet has changed radically during the past two generations: what was once the centerpiece at Sunday dinner is now a fast food; what was praised as a healthy source of protein is now maligned as a vehicle for fat.

The public health implications of this evolution were part of the conversation at a multidisciplinary conference at Yale College called “The Chicken: Its Biological, Social, Cultural, and Industrial History From Neolithic Middens to McNuggets.” Researchers, poultry workers and farmers attending the conference in May considered the chicken in relation to industrialization and globalization, workers’ rights and animal rights and even symbolism and folklore. Conference participants in public health focused on the “McNuggets” aspect of the contemporary chicken.

A roast chicken dinner was once considered a special meal, “a big deal,” said Marion Nestle, Ph.D., chair of nutrition and food studies at New York University. “Now it’s a junk food, a fat food. … It’s fried, so it gets maximum oil and breading.” Nestle believes that highly processed meats may be popular in part because Americans feel ambivalent about eating animals. McNuggets “don’t look very animal-like,” she said.

Deep-fried chicken meat, served as nuggets, “tenders” or strips, adds another inducement for overeating in a culture in which obesity is increasing—and where overeating is good for business. Food companies spend copiously on marketing because “the United States produces 3,800 calories per day for every man, woman and child in the country, and that’s about twice as much as most people need,” said Nestle. “The government is complicit in that marketing effort, because these companies are very, very large and like any other business, they support congressional campaigns.” Federal subsidies and price supports help keep chicken cheap, she said. The actual “farm value” of food in the United Sates averages 19 cents for each dollar consumers pay for it, Nestle said. The other 81 cents are spent on labor, shipping, processing, packaging, advertising and profit.

In restaurants that offer children’s menus, young diners are most likely to choose chicken, according to a study by conference participant Kelly D. Brownell, Ph.D., professor of psychology and of epidemiology and public health at Yale. Brownell and colleague Marlene B. Schwartz, Ph.D., co-director of the Yale Center for Eating and Weight Disorders, surveyed 10 major fast food restaurants and “family-style” chains. In eight of these restaurants, some form of fried chicken was the top choice for children. And in each case the meals contained more calories and fat and less fiber than the U.S. Department of Agriculture guidelines suggest a child should consume in a single meal, Brownell said.

Chicken has been considered healthier than beef, because it has less fat. Now, says Brownell, “chicken has gone from being part of the solution to being part of the problem.”

Yale team assessing neural stem cells as a treatment for Parkinson’s disease

Researchers at Yale are about to embark on a series of experiments to determine whether human neural stem cells can cure Parkinson’s disease that has been induced in monkeys by a neurotoxin. Pilot studies have shown that these cells can be successfully integrated into the brains of fetal, neonatal, infant and adult monkeys for at least a month.

The experiments, funded by a $2.4 million grant from the National Institute of Neurological Disorders and Stroke, are designed to determine whether the stem cells, once integrated into the brain, will restore the production of dopamine. Parkinson’s results from unknown processes that kill dopamine cells, causing muscle rigidity, lack of coordination, difficulty moving and tremors. Primordial and uncommitted, neural stem cells can be propagated in large numbers and then safely differentiated into the necessary dopamine-producing neurons after they are injected into the brain. “Stem cells appear capable of becoming the appropriate replacement cells for the lost dopamine cells in Parkinson’s disease,” said lead investigator D. Eugene Redmond Jr., M.D., professor of psychiatry and neurosurgery. “This appears to happen spontaneously when they are implanted into the correct areas of the brain, and there are also known methods as to how to get them to do this in culture.”

Stem cells have certain advantages over fetal brain tissue, which Redmond used in similar research a decade ago. In those experiments Redmond and other researchers, relying on private funding, transplanted brain tissue from aborted fetuses into the brains of patients with Parkinson’s disease. They reported some initial success, but over the years outcomes were mixed. The progress of that research has been slow, with a major drawback being the difficulty of finding sufficient quantities of suitable fetal cells.

Unlike the fetal cells, stem cells divide in culture, so adequate amounts can be produced and they can be made of uniform quality and meet established safety levels.

“The human neural stem cells migrate to populate developing or degenerating brain regions, perhaps allowing a functionally correct and effective reconstruction,” said Redmond.

Federal funding for the research is permitted because the stem cell lines are derived from fetal-cadaver brain tissue, not embryos. Research involving embryonic stem cells remains controversial. Last year President Bush announced that federal funding would be permitted only for research involving embryonic stem cell lines derived prior to Sept. 9, 2001.

The project, to be carried out in conjunction with scientists from Harvard Medical School, the University of Colorado and the St. Kitts Biomedical Research Foundation, also seeks to test whether the cells will survive, differentiate and integrate into the brains of normal adult monkeys without immunological rejection or harmful overgrowth.

“These studies will advance our understanding of the neurobiology and safety of human neural stem cells in a well-established, clinically relevant primate model of Parkinson’s disease and, if successful, will support safe clinical studies in patients with Parkinson’s disease in the future,” Redmond said. “The results will also advance our understanding of useful methods for studying and treating a broad range of neurodegenerative, genetic and traumatic conditions of the nervous system.”

Et Cetera

New building nearly finished

As the Congress Avenue Building approaches what is known in the construction trade as “substantial completion,” much of the remaining work is going on behind the scenes. Workers began digging a tunnel under Congress Avenue in June to connect the new building with the Laboratory for Surgery, Obstetrics and Gynecology across the street. The final phase includes the testing of electrical, heating, air conditioning and air filtration systems, said project manager Reyhan T. Larimer. Moving will begin in November and continue through March under the supervision of Freeman Enterprises, a New York firm specializing in moving scientific laboratories. First the building will undergo customization to accommodate special laboratory equipment. “The building was designed generically,” Larimer said. “Now we have to make minor adjustments for the people who are moving in.” We’ll examine the move in detail in the Winter 2003 issue of Yale Medicine.

Tribal tournament

In late spring the Mashantucket Pequot Tribal Nation of southeastern Connecticut, owners of the world’s largest casino, joined with 20 companies and dozens of individuals in a fund-raiser to benefit the Department of Pediatrics’ section of immunology. The Timber Spears Memorial Golf Outing, held in memory of a 3-year-old tribal member who died in August 2001, attracted 146 participants and raised more than $23,000. Timber Spears was born with a primary immune deficiency; his grandmother Phyllis Waite, a tribal elder, proposed the golf outing at the Foxwoods Country Club to encourage research into the condition. “We are grateful to his family for their efforts to help other children with primary immune deficiencies,” said José G. Calderon, M.D., who treated Timber from the time he was 2 months old. “The gift will provide resources and keep the child’s spirit alive.” Steve Tantillo, a Mashantucket Pequot Athletic Commission coordinator, said the golf outing will be repeated next year.


			Originally published in Yale Medicine, Autumn 2002. Copyright © 2002 Yale University School of Medicine. All rights reserved.