UPDATE: 9 April
More on the issue of computerized health records -----------------
UPDATE: 15 February - We are pleased to see that Bloomberg News seems to think that information we posted previously has merit.
However, based on an NPR interview this morning with David Leonhart, I for one have to wonder how he seems to have been so co-opted to believe that electronic health records are really a cost savings option. He seems more interested in using the collected data to find out how to re-do the health care system and to find out what works.
I guess Mr. Leonhart forgot to look up that study done at Harvard School of Public Health that showed that approximately 80% of health care is ineffective. And this is NOT a new study, its just no one has been very willing to step up and admit it after all these years.
OUTRAGEOUS Fed Health Control Hidden In Stimulus2-14-9
(Bloomberg) -- Republican Senators are questioning whether President Barack Obama's stimulus bill contains the right mix of tax breaks and cash infusions to jump-start the economy.
Tragically, no one from either party is objecting to the health provisions slipped in without discussion. These provisions reflect the handiwork of Tom Daschle, until recently the nominee to head the Health and Human Services Department.
Senators should read these provisions and vote against them because they are dangerous to your health. (Page numbers refer to H.R. 1 EH, pdf version).
The bill's health rules will affect "every individual in the United States" (445, 454, 479). Your medical treatments will be tracked electronically by a federal system. Having electronic medical records at your fingertips, easily transferred to a hospital, is beneficial. It will help avoid duplicate tests and errors.
But the bill goes further. One new bureaucracy, the National Coordinator of Health Information Technology, will monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost effective. The goal is to reduce costs and "guide" your doctor's decisions (442, 446). These provisions in the stimulus bill are virtually identical to what Daschle prescribed in his 2008 book, "Critical: What We Can Do About the Health-Care Crisis." According to Daschle, doctors have to give up autonomy and "learn to operate less like solo practitioners."
Keeping doctors informed of the newest medical findings is important, but enforcing uniformity goes too far.
New Penalties
Hospitals and doctors that are not "meaningful users" of the new system will face penalties. "Meaningful user" isn't defined in the bill. That will be left to the HHS secretary, who will be empowered to impose "more stringent measures of meaningful use over time" (511, 518, 540-541)
UPDATE: Received today:
HIPAA Does Not Protect Privacy -
HIPAA Privacy Rule May Inadequately Protect Patient Privacy and Hinder Health Research
Laurie Barclay, MD, Medscape Medical News
February 10, 2009 — The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule inadequately protects the privacy of personal health information and hinders important medical research studies, according to a report issued February 4 by a committee from the Institute of Medicine (IOM).
"We believe there is synergy between the goals of safeguarding privacy and enhancing health research and that it is critically important to our nation's health to strengthen privacy protections and still facilitate research," committee chair and coauthor Lawrence O. Gostin, professor of law and director, O'Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC, said in a news release. "Our recommendations aim to boost regulations and practices that effectively protect personally identifiable health information, while changing provisions of the HIPAA Privacy Rule or its interpretations that have proved to be ineffective."
The report calls for Congress to authorize the development of a totally different approach to safeguarding personal health data in research, distinct from the HIPAA Privacy Rule. Regardless of who supports or performs the research, privacy, data security, and accountability standards should be uniformly applied to data used in all health-related research.
In the interim, the report suggests a series of changes to improve the HIPAA Privacy Rule and the guidance regarding compliance with the rule given by the US Department of Health and Human Services (HHS).
Furthermore, because security breaches are a growing problem for health information databases, all institutions participating in medical research should heighten their standards for data protection. For example, encryption should be required for all laptops, flash drives, and other portable media storing sensitive data, as these devices can easily be lost or stolen.
Specific recommendations offered by the IOM committee include the following.
Congress should authorize Health and Human Services (HHS) and other appropriate federal agencies to develop a novel strategy for protecting privacy to be applied uniformly to all health research. HHS should exempt medical research from the HIPAA Privacy Rule once this new approach is implemented.
All health records used in research should be subject to privacy, security, transparency, and accountability obligations.
However, if national policy makers opt not to implement the above recommendation and instead opt for continued reliance on the HIPAA Privacy Rule, the committee recommends the following.
HHS should revise the HIPAA Privacy Rule and associated guidance.
Using revised and expanded guidance and recommendations for uniformity, HHS should reduce variability in interpreting the HIPAA Privacy Rule in health research by covered entities, institutional review boards (IRBs), and Privacy Boards.
HHS should develop a dynamic, ongoing strategy to improve empirical knowledge regarding current "best practices" in responsible research designed to protect privacy when protected health information (PHI) is used, and it should promote use of identified best practices.
To enhance privacy in research, HHS should promote increased use of "limited datasets," or partially deidentified data, and develop clear guidance on how to implement and comply with the associated data use agreements more efficiently and effectively. This should facilitate increased use and usability of data with direct identifiers removed.
To ensure appropriate IRB and Privacy Board oversight of PHI disclosures, HHS should clarify the distinctions between research and practice.
To enhance appropriate IRB and Privacy Board oversight of identification and recruitment of potential research subjects, HHS guidance documents should simplify the HIPAA Privacy Rule's provisions concerning the use of PHI in activities preparatory to research and harmonize those provisions with the Common Rule.
HHS should develop guidance materials regarding more effective use of existing data and materials for health research and public health purposes.
To facilitate use of repositories for health research, HHS should develop guidance clearly stating that individuals can authorize use of PHI stored in databases or associated with biospecimen banks for specified future research. As is allowed under the Common Rule, this would be done under the HIPAA Privacy Rule with IRB/Privacy Board oversight.
To simplify authorization for interrelated research activities, HHS should develop clear guidance for use of a single, multipurpose disclosure form. This form would allow individuals to authorize use and disclosure of health information in a clinical trial and to authorize the storage of their biospecimens collected during that trial.
Explaining the circumstances in which DNA samples or sequences are considered PHI would facilitate appropriate use of DNA in medical research.
To improve availability of data sets for research in a way that safeguards privacy, confidentiality, and security, HHS should develop a mechanism to link data from multiple sources.
Sections of the HIPAA Privacy Rule that involve heavy burdens for covered entities and hinder research without providing substantive improvements in patient privacy should be revised.
The requirements for accounting of disclosures of PHI for research should be revised by HHS.
To facilitate appropriate authorization requirements for responsible research, HHS should simplify the criteria used by IRBs and Privacy Boards in determining when they can waive the requirements to obtain authorization from each patient whose PHI will be used for a research study.
The committee suggests that the following recommendations, which are independent of the Privacy Rule, should be adopted regardless of whether recommendations I or II are implemented.
Changes required whether or not both policy options above should be implemented.
All health research institutions, including both covered and noncovered entities, should take strong measures to protect the security of health data. HHS should also support development and implementation of new security technologies and self-evaluation standards.
For members of IRBs and Privacy Boards who serve in good faith, HHS and/or Congress should offer reasonable protection against civil suits to encourage service on IRBs. However, there should be no protection for willful or wanton misconduct.
To better educate the public about health research, HHS and researchers should disseminate research results to study participants and the public and inform the public about how research is conducted and the value it provides.
"The new framework developed by HHS and other relevant federal agencies should provide strong and effective protection for often-sensitive personally identifiable health information and facilitate scientific discovery and medical innovation necessary to save lives and enhance the quality of the public's health," the report concludes. "And it should do so in a way that does not burden individuals with a flurry of health privacy notices and consent forms, or burden our health care system with a new level of bureaucracy and expense."
HHS, Robert Wood Johnson Foundation, American Cancer Society, American Heart Association/American Stroke Association, American Society for Clinical Oncology, Burroughs Wellcome Fund, and C-Change supported this study.
Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Published February 4, 2009.
UPDATE: I have been listening to the Obama PR push for the stimulus plan. Based on his total lack of understanding of the issue of electronic health care records I would encourage you to contact your members of Congress and express your concerns after reading some of the articles here that do address the facts.
Obama may think this approach will develop jobs - and it may - but who will pay for it? The consumer will pay in the end through higher health care costs and higher insurance premiums.
The projected savings in health care costs, based on the Obama plan, is ONE PER CENT (1%).And it does nothing to improve health care delivery. It is a clerical record keeping system. And who will get access to your records.....
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Earlier today I was a guest on the Katherine Albrecht program. For those of you who heard that interview here are some resources for more information -
Who Gets What: Billions for Health Care Insurance Computerizing Health CareMedical Billing CodesDaschleHIPAA Facts*** HIPAA Patient Rights Information CODEXAlliance for Natural Health Diet and LifestyleAmerican Health Freedom
Doctor-Patient Confidentiality Relationship in Jeopardy.
The economic stimulus bill, as currently written, mandates electronic health records for every citizen WITHOUT providing for an opt-out or patient consent provision starting in 2014.
The House has already passed this egregious bill and the Senate will consider the bill starting Monday.
"Without those protections, Americans’ electronic health records could be shared—without their consent—with over 600,000 covered entities through the forthcoming nationally linked electronic health-records network," says Sue Blevins, Institute for Health Freedom president.
“President Obama has pledged to advance freedom. Therefore the freedom to choose not to participate in a national electronic health-records system must be upheld,” Blevins says. “Unless people have the right to decide if and when their health information is shared or whether to participate in research studies, they don’t have a true right to privacy.”
The bill provides that a nationwide health information database be developed that allows for the electronic use and exchange of information and that facilitates health and clinical research. HIPAA already permits the disclosure of personal health information without patient consent for treatment, payment, and oversight of the healthcare system. The mandate contained in the stimulus bill is yet another attack on the longstanding doctrine of a patient’s right to consent and right to privacy.
Finally, is the stimulus bill even an appropriate vehicle to pass this unrelated matter of developing a nationwide electronic health records database? A patient’s right to privacy should not be taken lightly. Any restriction on a patient’s right to privacy should be open for discussion.
Please write your Senator and President Obama today to express your concern over the ongoing dilution of patient privacy rights. A sample letter is included for your convenience.
