Texas Election 2014: Abbott Pledges to Safeguard DNA

“Texas gubernatorial frontrunner Greg Abbott recently released an extensive list of items he says he’ll push for once elected.. Ths list includes gun rights, campaign ethics, and blocking implementation of the Affordable Care Act, but the number one item is safeguarding your DNA according to KUT News.”

To view the full article, please visit: Texas Election 2014: Abbott Pledges to Safeguard DNA

What a Small Moment in the Obamacare Debate Says About Ideological Media

Politics aside, a huge majority of the public agrees that ALL personal information should be protected online, not just when they apply for Obamacare, use electronic health systems, or search online about health.  The right to control the use of personal health data is strongly supported by 95% of Americans.

But like the public, the author doesn’t know that government and corporations already have access to every citizen’s personal health information. See: http://patientprivacyrights.org/truth-hipaa/  HIPAA has not protected our rights to health ‘privacy’ since 2002.

Key conclusions:

  • “The Bush and Obama Administrations both showed with perfect clarity that they don’t give a damn about the privacy rights of Americans; federal bureaucrats serving in both eras have broken the law to hoover up our private information; and every trend points to a federal government intent on expanding its ability to collect information on Americans and share it among agencies. The U.S. has also shown an inability to protect data it stores from being hacked or stolen. Given all that, it isn’t paranoid to imagine that any health information handed over to the federal government won’t remain private for long. A betting man would be wise to conclude that somehow or other, it will at least be seen more widely than Obama Administration officials are promising—especially if additional steps aren’t taken to make the information better protected.”
  • “Outsmarting the most hackish Republicans isn’t enough to fix the flaws in legislation that you championed and passed, substantial warts and all.”

Congress must pass a strong new law soon to giving patients a clear, strong right to control personal health information.  We should decide who can see and use our most sensitive personal information. The nation’s trust in government will only worsen if we cannot protect even our MOST sensitive personal data, from prescription records, to DNA to diagnoses.

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This blog was written in response to the following article: What a Small Moment in the Obamacare Debate Says About Ideological Media

DNA records pose new privacy risks

To view the full article, please visit: DNA Records Pose New Privacy Risks

An article in the Boston Globe highlights the ease with which DNA records can be re-identified. According to the article, “Scientists at the Whitehead Institute for Biomedical Research showed how easily this sensitive health information could be ­revealed and possibly fall into the wrong hands. Identifying the supposedly anonymous research participants did not require fancy tools or expensive equipment: It took a single researcher with an Internet connection about three to seven hours per person.” Even truly anonymous data was not entirely safe from being re-identified. Yaniv Erlich”…decided to extend the technique to see if it would work with truly anonymous ­data. He began with 10 unidentified men whose DNA ­sequences had been analyzed and posted online as part of the federally funded 1,000 Genomes Project. The men were also part of a separate scientific study in which their family members had provided genetic samples. The samples and the donors’ relationships to one ­another were listed on a website and publicly available from a tissue repository.”

These findings are incredibly relevant because it is highly possible that “something a single researcher did in three to seven hours could easily be automated and used by companies or insurers to make predictions about a person’s risk for disease. ­Although the federal Genetic Information Nondiscrimination Act protects DNA from ­being used by health insurers and employers to discriminate against people”.

Re: Genetic Bar Code Search – Finding People in Huge Gene Pools

In response to the PopSci.com article: Genetic Bar Code Search Can Use RNA to Pick Out Individuals From Huge Gene Pool

Quote from the principle investigator of the Mount Sinai study: “Rather than developing ways to further protect an individual’s privacy given the ability to collect mountains of information on him or her, we would be better served by a society that accepts the fact that new types of high-dimensional data reflect deeply on who we are,” he said. “We need to accept the reality that it is difficult—if not impossible—to shield personal information from others. It is akin to trying to protect privacy regarding appearances, for example, in a public place.”

Genetic privacy may be difficult to achieve, but it remains essential for people to trust physicians, researchers, health IT, and the government.

The public will not accept the idea that genetic information “is in the public domain” anytime soon. We never agreed to have our genetic information made public, and have fought for years to preserve genetic privacy at the state and federal levels. Those who built systems to take blood and tissue and do research without consent could have easily anticipated massive public concerns about such unethical research practices–and not built systems that violate Americans’ expectations and strong rights to health privacy.

Clearly it’s time for Congress to pass a federal law restoring personal ownership and control over blood and tissue that leaves our bodies, and restore the right of informed consent before any research can be done using our blood, tissue, or health information.

Is football worth surrendering genetic privacy for generations?

The NCAA mandated testing 170,000 athletes for the sickle cell trait because of a lawsuit following the death of a freshman in 2006. See the Washington Post article: Sickle cell testing of athletes stirs discrimination fears

The NCAA apparently did not consider the effect of testing on students’ future employment, even though carrying the sickle cell trait has long been a cause of discrimination.

Better training and monitoring of athletes could help prevent the deaths of athletes with other health problems besides the sickle cell trait, and prevent exposing athletes’ entire families to discrimination.

Quotes:

  • for decades blacks were stigmatized by sickle cell because they carried it far more commonly than whites, marking them as supposedly genetically inferior, barring them from jobs, the military, insurance and even discouraging them from marrying and having children.
  • Since 2000, as many as 10 Division I college football players who had the trait without knowing it have died suddenly following workouts.
  • “What doesn’t exist is scientific data to support the screening,” said Elliott Vichinsky, director of hematology-oncology at Children’s Hospital in Oakland and director of the Northern California Sickle Cell Center. “There are a lot of other people at risk for heat-related illness from exertion.”
  • The best solution, they argue, would be better monitoring, training and care for all athletes – a strategy that worked for the military.
  • “If you want to protect people, there’s an easy way to do that: change the training protocol for everyone,” said Lanetta Jordan, the Sickle Cell Disease Association of America’s chief medical officer.

The Case for Informed Consent

Austin, TX — Patient Privacy Rights (PPR), the nation’s leading health privacy watchdog released a white paper entitled, “The Case for Consent: Why it is Critical to Honor What Patients Expect: for Health Care, Health IT and Privacy.” The paper is designed to be a primer on health privacy and argues that the primary stakeholder in health care, the patient, must retain control over their personal health information. The white paper is available online at http://patientprivacyrights.org/wp-content/uploads/2010/08/The-Case-for-Informed-Consent.pdf.

The white paper tackles the arguments made that patient control is too technically difficult, is too expensive, or is too complex, among others. In fact, robust privacy-enhancing technologies are in use now that ensure both progress and privacy. Technology can enable control over personal health information today and likely simplify our systems and lower costs.

“Patients know what they want,” says Patient Privacy Rights’ founder, Deborah Peel, MD. “It is a mistake to design health IT in a paternalistic manner — assuming a corporation, vendor, provider or government agency knows what is best for each individual patient.”

View the white paper: The Case for Informed Consent

Re: State agency swaps babies’ blood for supplies

This is a response to the recent article in the Austin American Statesman: State agency swaps babies’ blood for supplies

Institutional Review Boards (IRBs) are NO LONGER the best solution – or even an adequate solution – for state problems (or for research) when informed consent is needed for the use of individual health information, tissue, or bloodspots. There are now effective, affordable technology solutions that enable individual families to make their own informed choices.

The state of Texas was sued because families could not individually decide how their spots were handled – whether they should be kept and how they could be used. Technology offers great solutions for those sensitive problems.

Governance of bio-banks like the NBS Program is critical as Dr. Callan points out, BUT governance cannot replace individuals’ existing rights to privacy and informed consent.

And there is no longer a need to use IRBs (typically stacked with members who have conflicts of interest) to replace individual families’ rights to make decisions about their child’s newborn bloodspots, now that technology offers much better solutions where each family can set their own preferences and be contacted for use/sale of their spots.

IRBs and privacy boards were needed in the past when the time and cost of contacting hundreds and thousands of people to ask consent for the use of their records was prohibitive, but that is no longer true thanks to technology. Millions can be contacted by email or text mail on cell phones instantly, at virtually no cost. And their responses can be addressed automatically via technology—think of online response cards when you donate money, you get an email confirming what you did. Technology can enable each family to make their own informed decisions.

There are many problems with using IRBs to replace individual informed consents. IRBs tend to be dominated by researchers and data users — people who want to use patient records or bio-specimens, rather than consumers and privacy advocates. IRBs have not focused on protecting medical record privacy — the focus has been on clinical research on the use and effectiveness of new drugs and devices that can directly harm people’s minds bodies weighing the safety of the study vs. the risk of side-effects and even death. IRBs were designed to protect people who participate in research from harm and death. So IRBs view research in patients’ records and bio-specimens as safe—as if no serious harms or risks result from these kinds of research. But research using bio-specimens or sensitive personal health information poses great risks to privacy. Personal health information, from prescriptions to DNA, are very valuable commodities that are sold and used to discriminate against patients and their children and grandchildren. Bio-specimens contain genetic information, which can be re-identified, and put families at risk for generations of discrimination.

In addition, the public does not agree that researchers should have unfettered access to their medical records. Open access to the nation’s sensitive health information is not seen as a desired public good. In fact Alan Westin’s survey for the Institute of Medicine on this subject showed that only 1% of Americans would agree to let researchers freely use their health records for any purpose. See: http://patientprivacyrights.org/media/WestinIOMSrvyRept.pdf?docID=2501

Also, the story did not highlight how deceptive ‘opt-out’ consents are. ‘Opt-out’ consent has been utterly rejected in the UK as the method of consent for transferring people’s health records to the NHS—the program had to be stopped when the public found out. ‘Opt-out’ consent was perceived by the public as deceptive, unfair, difficult to understand and enact. See: http://patientprivacyrights.org/2010/04/controversial-medical-records-database-suspended/

The proposal to ‘Save the Spots’ team including Patient Privacy Rights, the Genetic alliance, the UT LBJ School, and innovative technology corporations would have offered an online consent tool where Texas families could choose to:

  • Destroy the spot
  • store and do nothing
  • store and allow use for research, etc.
  • store and contact us for each use
  • send a copy of the test results to us for use with our doctor and our health planning

The story missed the key point about how technology can improve the informed consent process and create trust. Think about this example: you can set your preferences for how your bank pays your bills. Online banking allows you to set preferences for how something of yours ($ instead of spots or information)) is shared with whom, for what purpose. You can set up the bank to pay some bills automatically every month, others are one-time occurrences– ALL at your direction. And you can change your preferences at any time. We need dynamic, real-time patient-centric technology like that in the health care system—technology has NOT been used to assure patients rights, expectations, or convenience. I just saw a system for consent Friday where you can receive requests to use your health information on your cell phone, with the doctor’s name, and how long access is needed.

ALSO—the details about what we offered were not correct in the story—naturally we did not have the funding in hand when we went to the state. How would that be possible? We formally asked the state to agree with the plaintiffs for a delay for 90 days (easy to get from the judge, when both parties agree) so that we could seek the funding from federal and other state and national funders. Funders would not even look at our proposal UNLESS the state had agreed to work with us; ie, without the state’s agreement we could NOT DO IT. The state would not agree.

We could not have come to the state with funds for our proposal in hand—that’s why we needed the state’s formal agreement to the delay and approval to let us seek the funds to execute our proposal.

Unfortunately the story also did not explain why electronic consents can solve seemingly difficult problems, or why IRBs should no longer be used to replace individuals’ rights of consent when technology enables individuals to make their own informed choices about research.

The issue of what kind of consents we will have for the state of Texas as we move toward requiring and exchanging electronic health information is VERY CRITICAL—it is critical for lawmakers and the public to realize that innovative consent and privacy-enhancing technologies can be used to protect their rights in electronic health systems, not destroy them.

Again, you can see the Article referenced here at this link: http://patientprivacyrights.org/2010/05/state-agency-swaps-babies-blood-for-supplies/

Indian Tribe Wins Fight to Limit Research of Its DNA

This article from the New York Times, Indian Tribe Wins Fight to Limit Research of Its DNA, shows how patients are willing to opt in to certain research, but are outraged when their information is used for research and other purposes they are unaware of.

“SUPAI, Ariz. — Seven years ago, the Havasupai Indians, who live amid the turquoise waterfalls and red cliffs miles deep in the Grand Canyon, issued a “banishment order” to keep Arizona State University employees from setting foot on their reservation — an ancient punishment for what they regarded as a genetic-era betrayal.

Members of the tiny, isolated tribe had given DNA samples to university researchers starting in 1990, in the hope that they might provide genetic clues to the tribe’s devastating rate of diabetes. But they learned that their blood samples had been used to study many other things, including mental illness and theories of the tribe’s geographical origins that contradict their traditional stories.

The geneticist responsible for the research has said that she had obtained permission for wider-ranging genetic studies.

Acknowledging a desire to “remedy the wrong that was done,” the university’s Board of Regents on Tuesday agreed to pay $700,000 to 41 of the tribe’s members, return the blood samples and provide other forms of assistance to the impoverished Havasupai — a settlement that legal experts said was significant because it implied that the rights of research subjects can be violated when they are not fully informed about how their DNA might be used…”

DNA Destruction

In the weeks before state health officials destroyed more than 5 million newborn blood samples they had stored without consent, privacy advocates, parents and lawmakers reached a last-ditch accord to save them — but couldn’t convince the Department of State Health Services to sign on…

Peel said the state’s decision not to seek a non-destructive solution is a shame. She said there was national interest in “saving this treasure trove” of baby blood spots, and that she was working with researchers and lawmakers in Texas and Washington, D.C., to seek funding for a state-of-the-art research database that would allow parents to give consent electronically.

“We were going to … reach out to those 5 million families and let them know they had an alternative to having their blood spots destroyed,” Peel said.

Employers after DNA: GINA does not protect like you think.

See this CBS News article: Want A Job In Akron? Hand Over Your DNA

The idea that GINA protects genetic tests from being held or used by employers and insurers is wrong. Genetic tests ordered by your doctor at any other time–when you are NOT seeking a job or insurance–can be collected and used by your employer and insurer to make decisions about you.

Lobbyists for the insurance industry and employers got this massive loophole into the bill, eliminating the intended consumer protections. Instead GINA should have forbidden employers and insurers to ever collect or access genetic tests.

This is one of the key reasons we need Congress to restore OUR rights to control our personal health information, so WE can make sure employers and insurers do not get our genetic records. Genetic information is so sensitive it should ONLY be seen by health professionals directly involved in our treatment, or if we choose to participate in research and share it.