New CLIA rule talks the talk, but it doesn’t walk the walk

Deborah Peel, MD, Founder and Chair of Patient Privacy Rights

The federal government released an update to the CLIA rule this week that will require all labs to send test results directly to patients. But the regulations fail to achieve the stated intent to help patients. The rule allows labs to delay patient access to test results up to 30 days, and the process for directly obtaining personal test results from labs is not automated.

The new rule also fails to help patients in significant ways:

  • Real-time, online test results are not required. The federal government should have required all labs to use technology that benefits patients by enabling easy, automatic access to test results via the Internet in real-time. Unless we can obtain real-time access to test results, we can’t get a timely second opinion or verify the appropriate tests were ordered at the right time for our symptoms and diseases.
  • Labs are allowed to charge fees for providing test results to patients.  If labs can charge fees, they will not automate the process for patients to obtain results. Labs that automate patient access to test results online would incur a one-time cost.  After labs automate the process, human ‘work’ or time is no longer needed to provide patients their test results, so the labs would have no ongoing costs to recoup from patients.
  • Labs should be banned from selling, sharing, or disclosing patient test results without meaningful informed consent to anyone, except the physician who ordered the tests. This unfair and deceptive trade practice should be stopped. No patient expects labs to sell or share their test results with any other person or company except the physician who ordered the test(s).

This rule raises a question: why do so many federal rules for improving the healthcare system fail to require technologies that benefit patients?

Technology could provide enormous benefits to patients, but the US government caters to the healthcare and technology industries, instead of protecting patients.

Current US health IT systems actually facilitate the exploitation of patients’ records via technology. When HHS eliminated patient control over personal health data from HIPAA in 2002, it created a massive hidden US data broker industry that sells, shares , aggregates and discloses longitudinal patient profiles (for an example, see IMS’ SEC filing with details about selling 400M longitudinal patient profiles to 5K clients, including the U.S. government.

Meanwhile, even the most mundane, annoying, repetitive tasks patients must perform today–like filling out new paper forms with personal information every time we visit a doctor–are not automated for our convenience or to improve data quality and accuracy.

Shouldn’t IT improve patients’ experiences, treatment, and restore personal control over sensitive health information?

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You can also view a copy of this blog post here

Privacy and Health Care – Blog referencing PPR’s “The Case for Informed Consent”

The blog Emergent Chaos wrote an article urging for privacy in the mental health field as a means of minimizing the stigma associated with diagnosis.

Some key statistics pointed out in this post:

“First, between 13 and 17% of Americans admit in surveys to hiding health information in the current system. That’s probably a lower-bound, as we can expect some of the privacy sensitive population will decline to be surveyed, and some fraction of those who are surveyed may hide their information hiding. (It’s information-hiding all the way down.)

Secondly, 1 in 8 Americans (12.5%) put their health at risk because of privacy concerns, including avoiding their regular doctor, asking their doctor to record a different diagnosis, or avoiding tests.”

Re: Open data is not a panacea

Regarding the story on MathBabe.org titled Open data is not a panacea

This story is a much-needed tonic to the heavy industry and government spin promoting ONLY the benefits of “open data” without mentioning the harms.

Quotes from the story:

  • When important data goes public, the edge goes to the most sophisticated data engineer, not the general public. The Goldman Sachs’s of the world will always know how to make use of “freely available to everyone” data before the average guy.
  • If there’s one thing I learned working in finance, it’s not to be naive about how information will be used. You’ve got to learn to think like an asshole to really see what to worry about.
  • So, if you’re giving me information on where public schools need help, I’m going to imagine using that information to cut off credit for people who live nearby. If you tell me where environmental complaints are being served, I’m going to draw a map and see where they aren’t being served so I can take my questionable business practices there.

Patient Privacy Rights’ goal is a major overhaul of U.S. health technology systems, so your health data is NOT OPEN DATA. Your health data should only be “open” and used with your knowledge and informed consent for purposes you agree with, like treatment and research. It will take a major overhaul for the public to trust health IT systems.

Why does Patient Privacy Rights advocate for personal control over health information and against “open data”? Answer:

For reasons that are NOT apparent, the healthcare industry shuns learning from computer scientists, mathematicians, and privacy experts about the harms and risks posed by today’s poorly designed “open” healthcare technology systems, the Internet, and the “surveillance economy”.

The health care industry and government shun facts like:

YOU can help build a data map so industry and government are forced to stop pretending that the health information of every person in the US is safe, secure, and private. Donate at: http://patientprivacyrights.org/donate/

Re: Big Changes Coming in EU Privacy Law

Regarding the article in the Genomics Law Report: Big Changes Coming in EU Privacy Law

The new EU standards for data privacy apply to health data and require the level of personal control over health data and informed consent that Americans expect from electronic health systems, but don’t have. US companies doing business in the EU will have to comply with these tough new privacy protections in a year or face penalties. If companies can build privacy-protective systems there, why not here?

Quote:

  • Companies doing business in the EU must prove “every subject has given consent for the processing of their data for specified purposes. Consent is defined as “any freely given specific, informed and explicit [emphasis added] indication of will,” and can be withdrawn at any time. The subject will also have a controversial “right to be forgotten and to erasure.” This means that when the subject withdraws consent or “the data are no longer necessary” for the purposes for which they were collected, the company must render the data inaccessible, including on the Internet.”

Americans feel the exact same way the European public feels; they too want ethics-based systems that comply with longstanding rights to health privacy.

Since US companies will have to comply with strong patient privacy rights in the EU, they could obviously do the same in the US. Unless the US builds in the same strong patient protections, research comparing electronic health records in the US and EU will be impossible.

The Administration should use the EU example to move forward and require US electronic systems and data exchanges be built to comply with Americans’ longstanding rights to control the use of personal health information.

Consumer Advocate: Patient Consent Vital

Deborah Peel, M.D., founder of Patient Privacy Rights, on protecting the privacy of healthcare information.
Listen to the Interview Here.

Patients have inadequate control over who can access their healthcare information, but existing technologies can solve the problem, says consumer advocate Deborah Peel, M.D.

Her organization, Patient Privacy Rights, recently issued a white paper outlining an approach to giving patients opportunities to offer informed consent for accessing their records. In an interview, Peel outlined the key points in the report…

View a PDF version of the white paper: The Case for Informed Consent
Listen to the interview: Patient Consent Vital

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