On Tuesday, HHS Secretary nominee, Kansas Gov. Kathleen Sebelius, confirmed her support for the use of electronic medical records as a way of data mining patient information.
During the Senate hearings on her confirmation, Gov. Sebelius said that electronic health records (EHR) data was crucial to conduct “comparative effectiveness research [CER] to provide information on the relative strengths and weaknesses of alternative medical interventions to health providers and consumers.”
The stimulus bill passed with $1.1 billion allocated for CER to compare the clnical outcomes, effectiveness, and appropriateness of medical services. During the hearing, Sen. Pat Roberts from Gov. Sebelius’s own state of Kansas, expressed his concern that CER would be used to justify rationing by comparing costs, rather than effectiveness.
But Gov. Sebelius’s pledge to “provide every American with a safe, secure electronic health record by 2014” came on the same day that another breach of electronic medical records was leaking out.
The Mercury News reported that laptops containing 1,000 patient files were recently stolen at the Palo Alto Medical Foundation’s office in Santa Cruz, CA. (Mercury News, 3/31/09)
Even though the records were stolen in February, patients weren’t told until March 23, when they received a letter from the Medical Foundation. The records included diagnoses, treatment plans, E results and patient medical record numbers.
The laptop was stolen during a break-in when the office was closed. It was attached to a piece of equipment.
The Medical Foundation promises to do better in the future, and the Senate Finance Committee is expected to confirm Gov. Sebelius on Thursday.
Additional Information:
- “Great medical records roundup: The beginning of in-depth surveillance horrors?”, by James Bovard, Washington Times, March 13, 2009
- “Ruin Your Health With the Obama Stimulus Plan” by Betsy McCaughey , Bloomberg.com, Feb. 9, 2009.
- “Speeding on the Information Superhighway Will Result in Medical Pile-Up,” AAPS Congressional testimony, July 2005.
- “Data mining,” AAPS News, August 2006.
These several issues are too complex to settle in a brief letter, other than to say that patients should control their records, and patients could do so through encryption of their records at all times whether in the hands of government, medical ‘foundations’ or anyone else claiming good intentions.
As for emergencies, If I am unconscious and unable to reveal the password, so be it…
HButler@pol.net
The combination of coerced national EHR and “comparative effectiveness studies” will be a nightmare.
The use of EHR data to reliably detect uncommon (but strong, discrete) signals from a single drug or treatment is itself a Medical Informatics “Grand Challenge.” An example would be finding out about VIOXX’s association with myocardial infarction earlier than we did, via an EHR-based automated postmarket surveillance process.
Doing this is a “grand challenge” due to the nature of EHR data, which is as far from “clinical trials clean” as possible. The statistical methods needed to reliably pull signals out of the muck for even a single drug are still exploratory, the problems formidable if one wants to stay scientifically sound.
To detect relatively more nebulous “outcomes differences” between TWO OR MORE drugs or treatments via EHR data – did treatment A lower blood pressure more than drug B, did drug C lessen depression more than drug D – rises to the level of a “Grand Fraud.” It is near impossible to do with reasonable certainty from reams of EHR data, from different vendor systems, input by myriad people of different backgrounds with differing interpretations of terminologies (students/MD’s/RN’s etc) under different pressures (time, reimbursement maximization), and so forth.
Ominously, there is a lot of potential advantage to be had with terabytes of uncontrolled data and a political agenda. I fear that what will come from “comparative effectiveness research” that draws upon uncontrolled EHR data will be politics masquerading as comparative effectiveness research.
Ironically, the gold standard in medical science is the controlled clinical trial, yet EHR-based comparative effectiveness research itself as a research methodology, now touted by our government, seems to have gotten a pass.
Where are the meta-clinical trials that compare EHR data mining-based comparative effectiveness research as a methodology, vs. the “other” methodology of controlled clinical trials to compare drugs or treatments?
Good luck to private practitioners and medical innovators. Good luck, pharma. Good luck, patients.
This movement towards EHR uncontrolled data alchemy represents a further deviation from medical science towards the Syndrome of Inappropriate Overconfidence in Computing writ large.