Health Privacy by the Numbers

I’m married with children, so the concept of personal privacy is one that I abandoned years go.

Even so, I was somewhat surprised to learn that I am at “high risk” for having my private health information breached. On a scale of zero to 60, with 25 being the threshold for high risk, I scored a fig-leaf-curling 40 on a new test intended to gauge my vulnerability to health-data thieves. The color-coded equivalent of a “40” is a retina-searing red, which seems to indicate that nefarious entities are making off with my blood-pressure readings as I type this sentence.

The epiphany of unsecured data arrives courtesy of Patient Privacy Rights, which on Wednesday released its new Health Privacy Risk Calculator. The quiz calculates risk according to users’ answers to six questions. Unless you pay cash for everything, take no medications and forgo the customs of contemporary living, you too are at risk, according to PPR, which calls itself “the nation’s leading health privacy watchdog.”

Switch To Digital Medical Records Raises Concerns

Watch the Video of these interviews and read the full story HERE.

OAKLAND, Calif. — At his high-rise medical office in Oakland, orthopedic surgeon David Chang recently switched from those familiar but cumbersome paper medical files to digital records, making the change ahead of a federal requirement that goes into effect for all medical providers in 2014.

Chang now has a private company store his patients’ records electronically.

“Not only was it free – which was fantastic – but it saved me time,” said Chang.

That company is Practice Fusion in San Francisco. It’s part of a booming industry in electronic medical records software. Its service is free to some 30,000 doctors. KTVU discovered the reason the service is free is because the company legally sells the patient medical information it collects. Buyers include drug companies, medical insurers and others. They can get it if they say it’s for research…

…Some were opposed to such wholesale distribution of patient information.

“This is a nightmare. This is a nightmare. It’s nothing we’ve ever seen before in medicine,” said patient privacy rights advocate Dr. Deborah Peel.

Peel she said many patients and doctors don’t know the federal government quietly eliminated patients’ privacy rights for electronic records.

“It’s a free-for-all. It’s the wild west,” said Peel…

…Dr. Peel said new technology, for as little as five dollars a year, could protect your privacy and allow you to opt out of research databases. Privacy advocates said concerned patients need to lobby their lawmakers now.

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/

Problems with IBM’s new “massive” research study

Healthcare IT News released an article about IBMs new research project: IBM launches massive health data research project

IBM plans to bring together personal data on individuals far beyond what is available in the health care system – including environmental and financial data on individuals — to “pinpoint incentives governments and businesses might offer” to patients to improve health. The plan is to first study childhood obesity.

The problem is IBM’s research project does not appear to start with obtaining informed consent from the individuals (or their parents) whose data will be collected and studied.

There is no mention of the legal or ethical authority or basis that permits IBM corporation to collect, analyze, and do research on so much sensitive personal information on individual children, in order to decide which “actions” to incentivize to improve a particular child’s health.

Yet, IBM’s research aims to help doctors treating specific individual patients: “all these complex issues need to meld into a single thread of conversation as I talk to my patient.”

The story mentions numerous groups IBM is working with, but it appears that no consumer, patient, child, or privacy advocacy organizations are “partners” in this massive research project.

More Quotes:
• project will combine and analyze massive data sources that have never before been integrated to simulate the cause-and-effect relationships between agriculture, transportation, city planning, eating and exercise habits, socio-economic status, family life, and more
• project could help pinpoint incentives governments and businesses might offer or what types of investments might be needed and how to prioritize them • it’s been impossible to understand and to quantify precisely how each factor in our environment plays a role
• IBM researchers said they will partner with public policy and food experts, medical clinicians, economists, simulation experts, industry leaders, universities and others in this collaborative endeavor
• In many cases, the data and models exist. They just need to be put together in a consumable way that shows the wider connections and potential actions that can enhance individual and community health,” said Paul Maglio, an IBM researcher.

IBM launches massive health data research project

SAN JOSE, CA – IBM has announced it has launched a multi-year research project to connect and analyze enormous collections of data from a wide variety of sources to find ways to improve health. The project will initially focus on childhood obesity.

The IBM Research project will combine and analyze massive data sources that have never before been integrated to simulate the cause-and-effect relationships between agriculture, transportation, city planning, eating and exercise habits, socio-economic status, family life, and more, researchers said.

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…”

Your Medical Records Aren’t Secure

Published March 24, 2010

I learned about the lack of health privacy when I hung out my shingle as a psychiatrist. Patients asked if I could keep their records private if they paid for care themselves. They had lost jobs or reputations because what they said in the doctor’s office didn’t always stay in the doctor’s office. That was 35 years ago, in the age of paper. In today’s digital world the problem has only grown worse.

A patient’s sensitive information should not be shared without his consent. But this is not the case now, as the country moves toward a system of electronic medical records.

In 2002, under President George W. Bush, the right of a patient to control his most sensitive personal data—from prescriptions to DNA—was eliminated by federal regulators implementing the Health Information Portability and Accountability Act. Those privacy notices you sign in doctors’ offices do not actually give you any control over your personal data; they merely describe how the data will be used and disclosed.

In a January 2009 speech, President Barack Obama said that his administration wants every American to have an electronic health record by 2014, and last year’s stimulus bill allocated over $36 billion to build electronic record systems. Meanwhile, the Senate health-care bill just approved by the House of Representatives on Sunday requires certain kinds of research and reporting to be done using electronic health records. Electronic records, Mr. Obama said in his 2009 speech, “will cut waste, eliminate red tape and reduce the need to repeat expensive medical tests [and] save lives by reducing the deadly but preventable medical errors that pervade our health-care system.”

But electronic medical records won’t accomplish any of these goals if patients fear sharing information with doctors because they know it isn’t private…

Read More at The Wall Street Journal

There is no need to choose between the benefits of technology and our rights to health privacy. Please support YOUR right to decide who can see your electronic health information: sign the ‘Do Not Disclose’ petition now!

VA investigating security breach of veterans’ medical data

The Veterans Affairs Department’s inspector general has launched a criminal investigation into a physician assistant’s alleged downloading of veterans’ clinical data at its Atlanta medical center, sources have told Nextgov…

…The breach illustrates the need for patients, not clinicians, to control their medical records, said Dr. Deborah Peel, founder of Patient Privacy Rights, a nonprofit based in Austin, Texas, that works to ensure medical information remains restricted. She said control should include a requirement to obtain a patient’s consent to send clinical information to another doctor or to use it for research. Peel added electronic consent software currently exists to automate the process.

Ethics Debate Over Blood From Newborn Safety Tests

After those tiny blood spots are tested for a list of devastating diseases, some states are storing them for years. Scientists consider the leftover samples a treasure, both to improve newborn screening and to study bigger questions, like which environmental toxins can harm a fetus’ developing heart or which genes trigger childhood cancers.

But seldom are parents asked to consent to such research — most probably do not know it occurs — raising privacy concerns that are shaking up one of public health’s most successful programs. Texas is poised to throw away blood samples from more than 5 million babies to settle a lawsuit from parents angry at what they call secret DNA warehousing. A judge recently dismissed a similar lawsuit in Minnesota.

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.