UCSD gives consent for sharing medical records without patient approval

I got an interesting letter from UCSD three days ago. It told me that I had consented to share my electronic medical records.

The trouble is--I had NOT given my consent. I never signed a consent form. I never clicked a box on the Internet agreeing to share my records.

And the letter from UCSD did NOT arrive in my home mailbox or even in my email. It was purely by chance that I found it on MyUCSDChart—NOT among the MyChart emails. If it had been among the MyChart emails, I would have received an alert about it in my regular email.

UCSD was definitely NOT trying to make sure that I found out about my “consent”.

Today, each time I have clicked on the link about sharing electronic medical records on MyUCSDChart, I found myself unceremoniously thrown back to the sign-in page. Automatically signed out. They really don't like it when I click on the link!

UCSD seems to be remarkably fond of both signing me in and signing me out--without my involvement--whenever it feels like it.

I found this page on the UCSD site about sharing electronic records. It seems that I am now part of two databases: The San Diego Beacon Health Information Exchange, and something called Care Everywhere.

It's not that I want to keep my records secret. In fact, I think sharing electronic records is basically a good idea. It's just that I've had problems with health providers hiding my own test results from me, so I'm sensitive about doctors violating the law regarding medical records.

Apparently the VA is also part of this system, but the VA has a more transparent consent process.

I've heard of falsified medical records, but this is the first time I heard of a falsified consent for release of medical records.

See all posts regarding UCSD on Thank Heaven for Insurance Companies blog.
See all posts on medical records on Thank Heaven blog.



I found some interesting stuff about UCSD's informed consent process for patients in research projects:

iDASH Integrating Data for Analysis, Anonymization and SHaring

Informed Consent

Paper Consent versus Electronic Consent

Traditionally, paper-based consent has been the medium through which researchers and physicians conducted the informed consent process. The paper-based process consists of giving a hard copy consent form to a patient for him or her to review. Then a care provider answers any questions from the patient and in some cases assists the patient in reviewing the paper consent forms. The issues surrounding this procedure are that the paper-based consent form tends to be long and monotonous, and the retrieval of paper forms are often time consuming.

The new electronic consent forms use tablets or computers as the medium for communicating information and seeking consent from the patient...The iDASH team is also currently working on two systems, iCONS and iCONCUR, which are intended for such open source use in the future.

iDASH electronic informed consent management system

iCONS is a system currently being tested in a clinical trials environment at Moores Cancer Center Biorepository. The system supports informed consent electronically by enhancing the consent process for patients and researchers by acting as a consent broker and by adding multimedia aspects to the process. This consent process is opt-in, meaning no patient information is shared with researchers until the patient specifies what specific information he or she would like to share with researchers. The iCONS system creates a permission ontology to model the consent choices of the patient to assist in the process of releasing data and specimens to researchers for their consented uses.

iCONCUR is a pilot study within the University of California - San Diego Health System. This system transforms the sharing of electronic records from the opt-out system that is currently in place, meaning a patient’s record is automatically entered into the system unless the patient specifically requests to have their records taken out, to an opt-in system. The tool presents the patient with a taxonomy of his or her medical record allowing the patient to dictate what parts of the medical record to share and with whom it may be shared with.

HOSPITAL FAXED MEDICAL RECORDS TO PATIENT'S WORKPLACE

Tufts Medical Center sued for faxing patient records without consent
July 15, 2011
By Karen Cheung-Larivee
FierceHealthcare

Tufts Medical Center in Boston faces a lawsuit after a patient said the hospital faxed her medical records to her workplace without her consent, causing her embarrassment, reports The Boston Globe yesterday.

"I feel like I might have walked in (the office) naked," said patient Kimberly White.

White requested Tufts to send a form for a disability claim, but instead the hospital allegedly sent four pages of medical records about her hysterectomy to a shared fax machine at her workplace.

White filed a complaint in Plymouth County Superior Court. The hospital denies any wrongdoing, according to the article.

Tufts spokeswoman Julie Jette said, "In this matter, we complied with a patient's request to share information. We firmly believe we responded to the patient's request appropriately."

"I can't go back there," White said. "I am so embarrassed. ... I couldn't live with knowing what these people knew about me."

Earlier this year, another Boston hospital, Massachusetts General Hospital, faced accusations that an employee lost records of 192 patients on the subway. The hospital in February settled the federal case for $1 million, according to the article.

UCLA HIPAA VIOLATIONS

UCLA Health System pays $865G to settle HIPAA violation charges
July 8, 2011
FierceHealthIT
By Ken Terry

UCLA Health System has agreed to pay a fine of $865,000 and to develop a correction action plan to settle potential HIPAA privacy violations involving improper disclosures of medical records at its three hospitals, the federal Office of Civil Rights (OCR) reports.

OCR launched the investigation in 2009, following complaints by two unnamed celebrities that their medical records had been compromised. The government probe revealed that from 2005 to 2008, "unauthorized employees repeatedly looked at the electronic protected health information of numerous other UCLAHS patients," according to an OCR press release.

The Los Angeles Times reports that violations allegedly occurred at all three UCLAHS hospitals: Ronald Reagan UCLA Medical Center, Santa Monica UCLA Medical Center, and Orthopaedic Hospital and Resnick Neuropsychiatric Hospital, which are regarded as a single unit.

The hospital had disclosed in April 2008 that it had discovered that several employees had snooped into the patient records of dozens of celebrities, including Britney Spears, Tom Cruise and Maria Shriver.

When the alleged violations came to light in 2008, the California legislature passed a law that imposed escalating fines on hospitals for patient privacy breaches. The state fined UCLAHS $95,000 in 2009, reportedly in connection with the medical records of the late Michael Jackson.

The UCLAHS settlement with OCR is much smaller than previous HIPAA settlements, including those involving CVS Caremark ($2.25 million) and Rite Aid ($1 million).

As part of its settlement, UCLAHS agreed to institute new security and privacy policies, improve employee training, take action against employees who violate privacy rules, and designate an independent monitor to oversee compliance.

In a statement, UCLAHS said, "The UCLA Health System considers patient confidentiality a critical part of our mission of patient care, teaching and research. Over the past three years, we have worked diligently to strengthen our staff training, implement enhanced data security systems and increase our auditing capabilities."


MEDICAL ETHICS--RESEARCH ON MEDICAL RECORDS WITHOUT INFORMED CONSENT

J Law Med Ethics. 2008 Fall;36(3):560-6. doi: 10.1111/j.1748-720X.2008.304.x.
Research on medical records without informed consent.
Miller FG.

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.

PMID: 18840249 [PubMed - indexed for MEDLINE]

UCSD doctor concealed six-figure pay from medical device company and used that company's products on his patient did nothing wrong; UCSD says he did nothing wrong

Dr. William Taylor, UCSD, implanted screws from a company that paid him a six-figure income and in which he owned hundreds of thousands of dollars in stock options. UCSD paid for his legal defense, saying he did nothing wrong. UCSD paid $1.75 million settlement to avoid trial.

It took longer to uncover some critical details that Dr. William Taylor, the surgeon, had not told the retired special education teacher or the university: He owned stock options worth hundreds of thousands of dollars in the company selling the spinal devices and had also collected six-figure annual fees from the same firm, the lawsuit said. Disclosure of such corporate payments is required by state law and university policy.

A lawyer for UCSD said Taylor did nothing wrong and denied that any patients were harmed. But the university last year paid Kitrosser $1.75 million to settle the case.

Dr. William Taylor got his medical degree from UCLA, whose medical school seems have particular problems with conflicts of interest.

UC system struggles with professors' outside earnings
Failing to report compensation from other sources leads to concerns about conflicts.
BY MELODY PETERSEN
OC Register
May 25, 2014

Doctors eventually solved the mystery of why Brenda Kitrosser suffered from unrelenting pain after her back surgery at a University of California hospital in San Diego.

A UCSD surgeon had implanted experimental screws and other hardware into her back, promising this would relieve her pain. Instead the devices pressed on her nerves endlessly, according to a lawsuit she filed later.

It took longer to uncover some critical details that Dr. William Taylor, the surgeon, had not told the retired special education teacher or the university: He owned stock options worth hundreds of thousands of dollars in the company selling the spinal devices and had also collected six-figure annual fees from the same firm, the lawsuit said. Disclosure of such corporate payments is required by state law and university policy.

A lawyer for UCSD said Taylor did nothing wrong and denied that any patients were harmed. But the university last year paid Kitrosser $1.75 million to settle the case.

The controversy over Taylor’s undisclosed compensation is not an isolated case. The University of California has repeatedly failed to discipline medical professors who did not disclose payments from drugmakers and medical companies.

Last month, after UCLA paid $10 million to settle a lawsuit that centered on undisclosed corporate compensation, the non-profit group Consumer Watchdog called on state Attorney General Kamala Harris to investigate how widespread the unreported payments have become.

In a letter to Harris, the Santa Monica-based consumer group said that evidence presented in the case had shown that the university’s policies were “either inadequate or unenforced.”

“Patients in UC hospitals deserve the most reliable surgical devices and medication,” the group wrote, “and they shouldn’t be treated as subjects in expensive experiments.”

Officials at UCLA and UCI said they have recently increased efforts to make sure professors comply with the rules. UCLA doubled its compliance staff and hired a chief compliance officer. UCI’s chancellor directed all medical faculty to certify they were in compliance with reporting requirements and not engaging in unauthorized outside activities.

Those changes came after a series of undisclosed compensation cases involving professors from across the UC system. In each case, the professors who received the payments were involved in promoting or encouraging the use of a company’s product at the same time they were treating patients. In all the cases except one, it was people from outside the university who discovered the undisclosed payments.

• In a Los Angeles courtroom last month, Dr. Robert Pedowitz, the former chair of UCLA’s orthopedic surgery department, testified that administrators retaliated against him after he tried to get surgeons to report their corporate payments – including one doctor who said he had received $250,000 from a device maker for just 20 days of work. Just before closing arguments, UCLA agreed to pay Pedowitz $10 million to settle the case. The university said administrators did nothing wrong.


Dr. Thomas Ahlering
FILE PHOTO: MARK RIGHTMIRE, ORANGE COUNTY REGISTER

• At UC Irvine, Dr. Thomas Ahlering received more than $100,000 since 2002 from a company selling a surgical robot, but put most of that money in his nonprofit foundation without disclosing it, the Register reported last year. University officials say they have since required Ahlering to turn over $4,000 of that money to the school.

• An investigation by U.S. Sen. Charles Grassley in 2009 found that UCLA spinal surgeon Dr. Jeffrey Wang had failed to report almost a half million dollars in compensation he had received from several companies. UCLA officials say Wang was required to turn over an undisclosed portion of that to the university.

Although some of the professors were required to return a portion of their undisclosed pay to the university, it’s not clear whether the universities disciplined them in any other way.

In Oakland, UC administrators said they have an obligation to encourage faculty to work with companies to develop new medicines and medical devices that can help the public. And they pointed to the policies that the university has long had in place to require faculty to disclose payments.

“We also recognize that more can be done to increase transparency and oversight,” said Steve Montiel, a spokesperson at UC’s Office of the President, “and we are reviewing our policies to determine how best to achieve these goals.”

* * *

Under state law, UC faculty who are leading research must disclose publicly any payments or gifts they receive from the companies or other parties involved in those studies. They must also disclose how much stock or stock options they hold in that company.

According to university policy, all faculty also must disclose on internal annual reports how much time they are spending on outside activities, as well as how much they were paid for that work.

Even Moderate Drinking Increases the Risk for Cancer

Even Moderate Drinking Increases the Risk for Cancer
Zosia Chustecka
Medscape
April 08, 2011

April 8, 2011 — "A considerable proportion of the most common and most lethal cancers is attributable to former and current alcohol consumption," concludes a large European study published online April 8 in BMJ.

The researchers attribute about 10% of all cancers in men and about 3% of all cancers in women to previous and current alcohol consumption.

The estimates come from an analysis of data from the huge ongoing European Prospective Investigation Into Cancer (EPIC) and from representative data on alcohol consumption compiled by the World Health Organization (WHO).

The risk increases even with drinking moderate amounts.

"This research supports existing evidence that alcohol causes cancer and that the risk increases even with drinking moderate amounts," coauthor Naomi Allen, DPhil, an epidemiologist at Oxford University, United Kingdom, said in a statement.

The original data in the EPIC study were collected from 1992 to 2000, so "the results from this study reflect the impact of people's drinking habits about 10 years ago," Dr. Allen noted.

"People are drinking even more now than they were then, and this could lead to more people developing cancer because of alcohol in the future," she added.

Data From 8 Countries

The EPIC study, which is still ongoing, is one of the largest studies of diet and cancer ever conducted. It involved more than half a million people in Europe. For this analysis of alcohol and cancer, the researchers used EPIC data from 363,988 participants from 8 European countries — France, Italy, Spain, the Netherlands, United Kingdom, Greece, Germany, and Denmark. Two of these centers (France and the Netherlands) recruited only women, so the total cohort was about two thirds female (254,870 women; 109,118 men). Data on the incidence of cancer was obtained through record linkage with national cancer centers and from sources such as death certificates, health insurance records, and pathology reports. Information on alcohol consumption was collected using a detailed questionnaire about the frequency and amount of drinking and the type of beverages consumed during the previous year. The researchers also computed data on alcohol exposure in the general population using data from a WHO survey. Cancer Attributable to Alcohol The researchers assumed a causal association between alcohol and cancer of the upper aerodigestive tract (which includes the oral cavity, pharynx, larynx, and esophagus), liver cancer, female breast cancer, and colorectal cancer (as decreed by the WHO's International Agency for Research on Cancer). The team then calculated the proportion of these specific cancers that could be attributable to previous and current alcohol consumption. They estimated that, in 2008, alcohol was responsible for 44% of the upper aerodigestive tract cancers in men and 25% in women, 33% of liver cancer in men and 18% in women, 17% of colorectal cancer in men and 4% in women, and 5% of breast cancer in women. A substantial portion of these cancers attributable to alcohol consumption was linked to drinking more than the currently recommended upper limit, the researchers note. The World Cancer Research Fund and the American Institute for Cancer Research recommend a maximum of 2 drinks per day (about 28 g of alcohol) for men and 1 drink (about 12 g) for women. The team calculated that drinking more than this was responsible for 57% to 87% of the cancers attributable to alcohol (i.e., upper aerodigestive tract, liver, colorectal, and female breast cancer) in men and from 40% to 98% in women. "Our data show that many cancer cases could have been avoided if alcohol consumption is limited to 2 alcoholic drinks per day in men and 1 alcoholic drink per day in women, which are the recommendations of many health organizations," said lead author Madlen Schütze, PhD student and epidemiologist at the German Institute of Human Nutrition in Potsdam-Rehbrücke, Nuthetal, Germany. "Even more cancer cases could be prevented if people reduced their alcohol intake to below recommended guidelines or stopped drinking alcohol altogether," she said in a statement. Although a substantial portion of the cancers were attributable to high alcohol intake, the remaining cancers were attributable to drinking alcohol at or under the currently recommended levels. Risk Increases With Every Drink "The cancer risk increases with every drink, so even moderate amounts of alcohol — such as a small drink each day — increases the risk of these cancers," according to a press release from Cancer Research UK, which cosponsors the ongoing EPIC study, along with several European agencies. "Many people just don't know that drinking alcohol can increase their cancer risk," said Sara Hiom, director of health information at Cancer Research UK. "Cutting back on alcohol is one of the most important ways of lowering your cancer risk," along with not smoking and maintaining a healthy bodyweight, she said. The researchers touch on this point in their discussion. They refer back to studies that have shown a beneficial effect of alcohol on death from cardiovascular disease, especially coronary heart disease and ischemic stroke, which have in the past led to recommendations to enjoy a drink to benefit the heart. But they point out that "even though light to moderate alcohol consumption might decrease the risk for cardiovascular disease, and mortality, the net effect is harmful." "Thus, alcohol consumption should not be recommended to prevent cardiovascular disease or all-cause mortality," they write. No Sensible Limit The researchers also emphasize that this latest study, in addition to several others, shows that "there is no sensible limit below which the risk of cancer is decreased." This point was also made recently in an editorial in the Journal of the National Cancer Institute (2009;101:282-283), which accompanied findings from the British Million Women Study showing that even 1 drink a day significantly increased the risk for cancer (J Natl Cancer Inst. 2009;101:296-305). There is no level of alcohol than can be considered safe. At that time, editorialists Michael Lauer, MD, and Paul Sorlie, PhD, from the division of prevention and population sciences at the National Heart, Lung and Blood Institute in Bethesda, Maryland, wrote: "From a standpoint of cancer risk, the message of this report could not be clearer. There is no level of alcohol that can be considered safe." BMJ. Published online April 8, 2011. Full text

YOU MUST FILE A TORT CLAIM AT UCLA MEDICAL CENTER RATHER THAN THE STATE OF CALIFORNIA

YOU MUST FILE A TORT CLAIM AT UCLA MEDICAL CENTER RATHER THAN THE STATE OF CALIFORNIA

The University of California works hard to conceal the tort claim process.

You can't sue if you don't file a tort claim within 6 months, so the Regents try to prevent those who have been harmed from filing a tort claim.

At first I was duped by the following document published by the Regents of the University of California:

[Maura Larkins' warning: the following is deceptive, produced by the Regents to avoid tort claims.]

"The Office of The General Counsel of The Regents (“OGC”)... THE REGENTS IS NOT SUBJECT TO CLAIM-FILING PROVISIONS OF THE TORT CLAIMS ACT California Government Code section 905.6 exempts The Regents of the University of California from claim-filing provisions of the Tort Claims Act. A claimant who wishes to file suit against The Regents may serve OGC as specified in section 1 above."

But if you go to "section 1 above", you see an address in San Francisco. It's the wrong address for filing a tort claim. Clearly, the Regents want you to come to them for health care, but if they harm you, they don't want to repair the damage.

I did more research and deciphered the truth with much difficulty. You have to present a tort claim to the specific campus medical center that is involved.