Open Source Research

See the Government Health IT article: NCI to open research grid to cancer patient 'army'

Women desperate to cure breast cancer are contributing their sensitive personal health information to "an army" of researchers.

But there is no reason that these altruistic women have to risk their futures and their daughters' futures to find a cure.

It's possible to do research without risking their futures and their daughters' and granddaughters' futures by using privacy-protective technologies and robust informed electronic consent. But this project does NOT protect the privacy of these generous and well-intentioned women.

The women's data can be downloaded by "thousands of users"--all of whom make copies of their extremely sensitive, IDENTIFIABLE records. The records are identifiable so that the women can be contacted by researchers.

Some of the major things wrong with this picture:
1) The NCI system allows “researchers (to) form and maintain large breast cancer disease databases.” Is there any way to tell if the security is ironclad, state-of-the-art? No.
2) How many copies will researchers make? How many times will the data be replicated and backed-up across the world? No way to know.
3) What countries will copies of the records be kept in? No way to know.
4) How many and which researchers will download and keep their data? No way to know.
5) The researchers must sign agreements to protect and not sell the data, but there are no 'data police' to enforce those agreements. If there are no 'data police' watching this data, how do the women know it's safe? No way to know.
6) What if a woman does not approve of a particular study or researcher who has their data? Can a woman prevent any researcher from using her information? No.
7) How will the data be handled after the research study is complete? How will the women know if it is destroyed? No way to know.
8) How safe is research access via a web browser? No way to know

The severe flaws in this plan are obvious. Fearful women desperate for cures are being exploited by the government and the research industry that designed these systems to serve their needs, NOT the women's rights to privacy. Putting such sensitive data out into cyberspace KNOWING it can never be retrieved or destroyed is grossly irresponsible. Like Paris Hilton's sex video, this data will live forever in cyberspace, risking future jobs and opportunities of every child of every woman desperate for a cure.

The NCI could do this a better way---we can have research and privacy at the same time. But the privacy protective technologies that can enable both are not being used. Why not?????

See our testimony Sept 18th at the national HIT Policy Committee and the many letters from the Coalition for Patient Privacy to federal agencies and Congress describing how to do research while protecting privacy.

And NO--the Genetic Information Nondiscrimination Act (GINA) DOES NOT protect our genetic data. It allows insurers and employers to have our genetic data and it has no enforcement. Zero. And HIPAA has no protections for genetic data either--it allows others to control and use our data without consent.

The cost of contributing to research should not be that your female descendents are unemployable. Unless data is protected, we will have generations of people who cannot work because employers will not risk hiring anyone at risk of getting a disease.

De-identified? Yeah, right.

See these articles:
Netflix Contest Seen As Posing Privacy Risk
Netflix is about to commit a privacy Valdez with its customers' viewing data
AOL, Netflix and the end of open access to research data

Once again Netflix plans to violate the privacy of those who rate the movies they rent. Two University of Texas computer scientists demonstrated that the Netflix database of 500,000 with movie ratings could be re-identified, revealing sensitive political and sexual preferences of the actual people who rated movies. Netflix did not get the consent of renters to expose their ratings to the public or ot researchers.

Yet Netflix is moving ahead to release even MORE personal data for its next million-dollar contest. The major media (NYT's STeve Lohr for example) has NOT reported at all on how Netflix is violating movie renters' privacy, but instead trumpets the prizes paid to those who develop more accurate ways to predict which movies you will want to watch next.

The problem of re-identification is VERY serious for the healthcare system because health data is impossible to de-identify. It is so rich in detail that de-identification is almost impossible.

Today, the treasure trove of all Americans' sensitive health data is being endlessly used and disclosed without informed consent to millions of "covered entities" and "business associates" (and their millions of employees)--subjecting EVERY American to the theft, sale, and misuse of the most sensitive personal information that exists.

Who will hire you knowing all about your prescriptions, illnesses and genes?

Data-mining: Australia Just Calls It Something Else

In Australia, the data mining industry pays doctors to sell patients' prescription records. In the US they pay pharmacies, hospitals, and PBMs. See Article.

A complaint to the Australian Privacy Commissioner was dismissed because the data miners claimed that patients and doctors were "de-identified". But it is very difficult to fully de-identify personal health data so that re-identification is impossible. If true, the industry should have offered proof that their methods actually work and that the data cannot be re-identified.

As in the US, the theft and sale of personal prescription records is rationalized with claims that it can be used to "provide valuable insight into healthcare trends-- including the spread of infectious diseases". The word that describes using data to provide "valuable insights" is "research". It happens to be both illegal and unethical to do research without informed consent.

First HIT Policy Committee Meeting on Stripping Privacy Away?

No surprise the new HIT Policy committee is gearing up to eliminate privacy, i.e. patient control over personal health information, using the excuse that the entire nation's records are needed for biosurveillance and research without informed consent. See the quotes from Drs Calman and Clark. The title of the article says it all: "Committee studies public health, research".

The committee is dominated by industry appointees who will make sure the policies they come up with grant unfettered government and industry access to Americans' most sensitive personal data, from prescriptions to DNA.

What they don't get is they will lose the public's support and trust if they build a system where everyone's health records can be data mined for any research purpose. A Westin/Harris IOM poll found only 1% of the public would allow researchers unfettered access to their electronic medical records. The government and the research community are completely at odds with the public's rights to health privacy.

The reality is millions of Americans already refuse to participate in healthcare systems that harm them because they have no control over their medical records.

HHS noted in the Preamble to the HIPAA Privacy Rule that 600,000 Americans/year avoid early diagnosis and treatment for cancer because treatment records are not private private. Two million people/year with mental illness avoid diagnosis and treatment for the same reason: their records are not private. The Rand Corporation found that 150,000 Iraqi vets refuse treatment for PTSD because their treatment is not private, resulting in the highest rate of suicide in active duty military personnel in 30 years.

Can this commitee face reality when they have severe conflicts of interest and want the use of Americans' health data?

The lack of privacy drives millions away from healthcare. And the lack of privacy causes suffering and death--bad outcomes.

It looks like patients' and consumers' best hope for preserving their health privacy rights in electronic systems may be Gayle Harrell. She may be the only committee member who can face reality.

DoD does WHAT?

It is fascinating that the DoD clearly believes it owns and can use the personal health information of 12 million active duty military personnel for whatever purpose it decides. In this case, the DoD is paying a for-profit corporation to do research on active duty military personnel without their consent.

Maybe when you join the military you lose all privacy and Constitutional rights. I don’t know, I'm not a lawyer. If so, that is a steep price to pay to serve your country: losing all health privacy for yourself and your relatives forever. Do those who join the armed forces know they are signing up to become medical guinea pigs? Do they really understand the consequences for their futures and their families futures?

Many questions abound:

• Are the electronic records adequately secured? What a rich target: 12 million health records! What if enemies hack the privately held data base to learn about key military leaders?

• Will Phase Forward continue to use and sell the records for other purposes as HIPAA authorizes? Other data management corporations (such as Thomson Medstat) the government pays to perform fraud and waste audits obtain millions of health records that they later aggregate and sell to employers without anyone's consent.

• Furthermore--this is clearly medical research without informed consent. That is simply unethical and illegal. The US signed the Declaration of Helsinki after WW II because Nazis did human research without consent. Back then America recognized the need for informed consent before research takes place. Today, the codes of research and medical ethics still require patients to give informed consent before personal records can be used or disclosed. Why is this project not being done with informed consent when new 'smart' electronic consent tools could make it easy, cheap, and fast to obtain informed consent and explain all the risks and consequences?

Review this article from the Washington Post's Government Inc. Blog for more information:
Data Mining for DoD Health

Job 1 for the AHIC successor? -- by Nancy Ferris

Notice how the for-profit research industry wants access "baked" into all EHRs up front for research uses, to avoid getting individuals' consents.

They call this a "value case" for the nation's electronic health system. What great Lakoffian re-framing and propaganda. How do you argue against "value"?

It’s a "value" alright, just not a "value" for patients, because it sets up a system that is both unethical (no consent) and illegal (violates Amercians' longstanding rights to privacy).

The story says the research industry wants open access to "de-identified" data, but that is NOT what they tell Congress or the regulators. They say they must have access to longitudinal data, which CANNOT be de-identified, because most research cannot be conducted using de-identified data.

The new AHIC 2 will be industry-driven and industry-paid for, with so-called "standards" being devised to meet the needs of corporations, not to adhere to the laws and ethics that governed the healthcare until the '90's and the advent of electronic systems for health data.

Today there are 'smart' technology solutions to make consent easy, cheap, understandable, and instantaneous (see the consents on HealthVault by application partners for a preview of how simple and clear and specific consents can be). Electronic consents can be interactive and actually explain things, rather than be densely written in legalese so no one understands them.

Why continue to use the kind of privacy-violating blanket coerced consents that were necessary in the paper health system? 'Smart' technologies can do a far better job. Using robust consent management tools, we can obtain valid and easy-to-understand specific, time-limited, and cheap consents from millions instantaneously.

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