Navigation Links
Rules on Patients' Medical Data Hampering Research
Date:11/13/2007

In survey, most scientists said current laws are too cumbersome

TUESDAY, Nov. 13 (HealthDay News) -- Regulators may be going too far in their efforts to protect human research subjects, a new survey of research scientists suggests.

Two-thirds of doctors recently surveyed said that the Health Insurance Portability and Accountability Act (HIPAA), which oversees the release of patients' medical information, has hindered research. Only one-quarter felt the new rules had actually enhanced patients' confidentiality and privacy.

"According to the scientists surveyed, HIPAA is slowing and adding cost to clinical and population research. This has the potential to delay important research findings," said Dr. Roberta B. Ness, the study's lead author and chair of the department of epidemiology at the University of Pittsburgh Graduate School of Public Health.

"The pendulum has been swinging for decades and is continuing at light speed. There is no sign of it swinging back," added Dr. Norman Fost, author of an accompanying editorial and chair of the Institution Review Board at the University of Wisconsin School of Medicine and Public Health in Madison.

The study is published in the Nov. 14 issue of the Journal of the American Medical Association.

The original intent of the 1996 HIPAA Privacy Rule was to allow consumers to carry their insurance from job to job. But the final version tilts more toward protecting the privacy of medical records and information.

"Currently, an Institute of Medicine/National Academies panel is considering what suggested actions should be taken," Ness noted. "These may include suggesting changes in the rule or better guidance and implementation. That report should be out next summer or fall."

According to background information in this paper, HIPAA was supposed to find a balance between protecting individuals' privacy and allowing the use and disclosure of the information for social goals.

The rule allows health-care provider organizations to disclose individual information for research purposes, but only if the researcher gets written consent from each patient or obtains a waiver of the requirement.

There has been some evidence that HIPAA has slowed or even halted research, but there have been no large, generalized studies until now.

This study, commissioned by the Institute of Medicine, is based on surveys filled out by more than 1,500 epidemiologists conducting research on U.S. human subjects.

More than two-thirds (about 68 percent) of respondents said that the HIPAA Privacy Rule has made research more difficult at a level of 4 to 5 on a 5-point scale (5 indicating a great deal of added cost and time to complete a study).

Almost 40 percent said HIPAA had increased research costs in the high range, and half said that a high degree of additional time was now needed to complete research projects.

Almost half felt that the rule had greatly affected research related to public health surveillance.

Only 10.5 percent of respondents indicated that the rule had strengthened public trust, and only about 26 percent felt the rule enhanced participant confidentiality and privacy to a great degree.

Respondents also felt that the privacy rule had a negative influence on human subjects' protection more often than it had a positive influence.

"The one positive was that 25 percent felt that HIPAA had increased privacy," Ness said.

An accompanying editorial described a system mired in minutiae, including requirements for meticulous documentation.

The solution?

"The research community needs to push back. It needs to stop just caving in," said Fost, who is also professor of pediatrics and founder/director of the bioethics program at Wisconsin and who has received national recognition for his efforts to protect human research subjects. "It may be that there needs to be litigation," he said.

And, added Fost, "the basic structure [for research] that is already in place is very good. There's no question that the profession was not doing a good job on their own, and they needed to be forced to set up IRBs [institutional review boards] and make them work. But in 1983, a presidential commission concluded that the system was working very well."

More information

To learn more about HIPAA, visit the U.S. Department of Health and Human Services.



SOURCES: Roberta B. Ness, M.D., professor and chair, department of epidemiology, Graduate School of Public Health, University of Pittsburgh; Norman Fost, M.D., chair, Institutional Review Board, professor, pediatrics and founder/director, bioethics program, University of Wisconsin School of Medicine and Public Health, Madison; Nov. 14, 2007, Journal of the American Medical Association


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Proposes New Rules for Sunscreens
2. Texas Supreme Court Rules Against Medicare HMOs in Hospital Reimbursement Fight
3. Physician Skin Care Specialist Says Proposed New Rules for Sunscreen Products Will Better Protect the Public
4. First Circuit Court of Appeals Rules Against Philip Morris in Lights Class Action
5. Judge Rules That Florida Disease Management Program Serving 8,000 HIV/AIDS Patients Should Be Re-bid, Says AIDS Healthcare Foundation
6. New transfusion rules restrict donations from previously pregnant women
7. Revised California Stem Cell Research Rules Fail to Ensure Affordable Access to Cures, Consumers Warn
8. Draft Rules Wont Stop Insurers Illegal Cancellations of Health Policies
9. Experts Propose Rules to Rate Hospitals Safety
10. Fluctuating eye pressure associated with visual field deterioration in glaucoma patients
11. Comparison of obstetric outcomes between on-call and patients own obstetricians
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Rules on Patients' Medical Data Hampering Research
(Date:10/13/2017)... LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for care ... is the 90-day elimination period, when the family pays for care, is often waived, ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... 2017 , ... Coveros, a leader in agile coaching services ... by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile Transformation ... Agile methodologies in a consistent and high value manner across CMS programs. Coveros ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare ... program management, will showcase a range of technology and learning solutions at the ... Convention and Expo to be held October 14–18, 2017 at the Mandalay Bay ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., a ... design, and immune-engineering today announced the launch of ... development of personalized therapeutic cancer vaccines. EpiVax has ... exclusive access to enabling technologies to the new ... will lead EpiVax Oncology as Chief Executive Officer. ...
(Date:9/19/2017)... HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform ... leadership team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led ...
(Date:9/13/2017)... has been named the official orthopedic and sports medicine ... 2018 College Football Playoff (CFP) National Championship to be played ... Atlanta, Georgia . OrthoAtlanta is proud to be ... many activities leading up to, and including the national championship ... OrthoAtlanta serves ...
Breaking Medicine Technology: