Every time you go to the ATM machine, you are cutting the cost for banks to provide services to you by a whopping 65%. That’s the difference in administrative & processing costs between a teller transaction and one handled by the customer at an ATM. Not to mention the amount of time you are saving you.

It is estimated, that like the banking industry in the 1960s, healthcare providers today spend over 50% of their human resources on patient record keeping and record management. Patients, in turn, spend 75% of their time sitting in waiting rooms and doing paperwork – and/or waiting while the care provider does theirs.

In addition to the obvious need to keep exemplary records of patient treatment, allergies, drug prescriptions, and the like; today’s healthcare providers must address governmental regulatory constraints such as HIPAA and OSHA; health insurance reporting, filing and coding; Medicare & Medicaid compliance; the demands of legal protections around malpractice and liability; and much more.

In an effort to reengineer the cost per patient ratio in American healthcare, the Obama administration (and admittedly, several prior administrations – of both parties) has targeted the cost of patient record keeping and record management as a key success factor in healthcare reform. While this is the right target, not much of the work to date (nor much of that proposed) has resulted in cost reductions for either the healthcare provider or the patient.

The answer may lie in the lessons learned from the ATM.

Giving the patient responsibility for the accuracy and availability of their health records is not much different than expecting a person to be responsible for their financial records. What’s truly exciting about this approach is that it can improve the privacy profile well beyond what HIPAA requires.

By using the internet and a set of well designed secure web “Patient Registry” applications an individual patient could:

• Develop a single heath history and personal health profile – like the history profile everyone fills out time and time again when applying for healthcare or admittance to a health facility;
• Define emergency contacts, successor information, power of attorney and life support instructions;
• Disclose which providers or healthcare interests can have access to their records, and what topics might be restricted and to whom they are restricted.
• Ask to be notified when anyone accesses or attempts access to records – or certain topics (mental heath, for example);
• Remove much of the legal burden from providers with regard to record accuracy between unrelated healthcare events;
• Perform periodic review (or assign a reviewer) to insure continuity of information, treatment, charts and records.

For the care providers, this approach has some immediate benefits. Any person that utilizes this Patient Registry has a fast path through applications, admissions, referrals and appointments. By entering the individual’s SSN and a PIN number – assigned by the patient to the provider – the entire patient history and the history of all relevant treatment, diagnosis or medical advice is available electronically and instantly.

This is only the beginning. As electronic records and digital diagnostic data (such as MRI, CAT Scans, X rays, etc.) become available, they can be linked to the Patient Registry data and automatically reviewed by patient and provider alike. The patient’s insurance company or employer may be given access to certain information to speed payment or reimbursement. Medicare, Medicaid and Social Security access could be granted to reduce, if not eliminate the paperwork and delays involved in treatment assessment and reimbursement.

Reality Check

You may ask “Well, if it’s this simple why hasn’t anyone tried to do it?”. The answer is – they have. Personal healthcare records (PHC) web sites such as Zweena [http://www.zweenahealth.com] or MyPHR from Allima [http://www.myphr.com/] are just getting started. But once again, these attempts are based on self-interest or self-promoting programs. They are competitive ventures that seek to be different from one another rather than be a standard around which all patients, care providers, insurance companies – and federal, state & local government regulators – can frame a record management solution.

Until the patient is directly in charge of their medical records and history – securely and free of charge – none of the extensive and expensive electronics records initiatives will result in major savings. As long as PHR sites, providers, record keepers, laboratories, governments and insurance companies attempt to create holistic solutions – based on their business interests – without first addressing root standardization and the basic needs and rights of the patient – we will fall sort of true reform; Not to mention true cost containment.

Of all hype around what role the federal government should play in healthcare reform, the establishment of a standardized patient registry organization (PRO) would have the most impact on reform and the least impact on the federal budget of any proposal. As an independent, non-profit organization – with record standards developed by the medical industry, the National Institutes of Health (NIH), the U.S. Department of Health and Human Services (HHS) and the insurance industry – the PRO could remain autonomous and independent of industry and government influence. Its sole purpose would be the establishment, standardization, accuracy and protection of personal healthcare records – managed by the individual patient; a healthcare “ATM”, if you will.

Been there..

In 2006 I developed the architecture and design of such a system. Repeated attempts to get it in front of responsible interests in Washington have met with futility.

But I keep trying…

JB

References and Sources

Beaudoin, J. l (2006). Article: HHS to fund trial NHINs in 2007; Healthcare IT News;http://www.healthcareitnews.com/story.cms?id=6036

Bogatin, D. (2007). Blog: Google scary now? Personal Health Records, sponsored by Google, next; ZDNet.com; Retrieved August 22, 2007 from: http://blogs.zdnet.com/micro-markets/?p=1261

Broder, C. (2005). Article: Feds seek national health information system prototype; Healthcare IT News, http://www.healthcareitnews.com/story.cms?id=2978

HIPAA, (2006). Health Insurance Portability and Accountability Act, as referenced at,http://aspe.hhs.gov/admnsimp/pl104191.htm

HIMSS News (2006). Seeking Stakeholder Representation for HIMSS/NEMA MDS2 Joint Standards Writing Committee, http://www.himss.org/ASP/ContentRedirector.asp?ContentID=66391&type=HIMSSNewsItem

Rehm, S., Kraft, S. (2001), Electronic Medical Record Systems, American Academy of Family Physicians (AAFP), Retrieved January 8, 2005 from:http://www.aafp.org/fpm/20010100/45elec.html

Weinert, K. (n.d.). A Brief History of ATMs, retrieved May 16, 2009, from:http://www.stopatmfees.com/newpage3.htm

Other Reading:

American Health Information Management Association (AHIMA), Coding Policy and Strategy Committee, Payer’s Guide to Healthcare Diagnostic and Procedural Data Quality, [2001] http://www.ahima.org/infocenter/payersguide/payersguideprt1.pdf

Electronic Health Records Workgroup, U.S. Department of Health and Human Services, Washington, D.C. http://www.hhs.gov/healthit/ahic/ehr_main.html

HIPAA Compliance, Financial Payment Clearinghouses,http://www.hipaabanking.org/healthcare.html , January, 2005

Medical Privacy – National Standards to Protect the Privacy of Personal Health Information, http://www.hhs.gov/ocr/hipaa/ , January, 2005.

National Guideline Clearinghouse, a public resource for evidence-based clinical practice guidelines at http://www.guideline.gov/ , January, 2005

Can someone own you? Can they own your biological parts – such as your genes?

Yes they can. And you might be surprised to learn that the biggest owners of human genetic info are not corporations, but universities.

The ACLU is trying to upend a practice that goes back to 1980 when the U.S. Supreme Court found in favor of an inventor that used human bacteria to engineer a microbe that dissolves oil. The “bacteria” was a genetic “discovery” of an existing organism and the bacterial genes were patented as a component in the microbe invention.

U.S. Patent Law is developed to protect the genesis of invention. In doing so, the law defines the term “invention” to mean invention or discovery [35 U.S.C. 100 Definitions. Para (a) ]. That “or discovery” part is what all prior genetic patents relied upon. So the fact that one discovers a gene – is set apart from actually doing anything with it; like creating an invention. So while it can be argued that the precedence set by the Supreme Court in 1980 was to effectively protect the components of an invention, subsequent patents have not had to pass this test, apparently. And the Court’s ruling did not elaborate on the aspect of invention as a precursor to patenting a genetic discovery.

So what’s wrong with gene patenting anyway? Well, the case in which the ACLU is involved is a prime example. A Utah university and a private drug company jointly hold patents on genes named “BRCA1” and “BRCA2”. These genes have been proven responsible for many cases of hereditary breast and ovarian cancers in women.

By owning the genes, they also own the test for them. So if a woman wants to be tested to see if she has genetic markers for breast or ovarian cancer, she will have to pay the patent holding drug company $3000. Clearly this is not the intent of patent law, especially when federally supported universities are involved.

“It is the policy and objective of the Congress to use the patent system to promote the utilization of inventions arising from federally supported research or development…to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions,…” [35 U.S.C. 200 Policy and objective.]

Since “Inventions” is also defined as “discovery”, this policy applies amply to the ACLU “unreasonable use” assertion.

You will be happy to know, however, that the practice of patenting your genetic code is, for all practical purposes, stopped completely. The Human Genome Project (HGP), which has successfully mapped the entire human genome, has made all our genes a matter of “public record”… so patents on solely the ‘discovery’ of a human gene are no longer valid. You can still patent an invention made from them… but not the genes themselves.

But the issue of patenting discovery still has ominous connotation. And while much of our genetic code is now protected from this practice – (and the patents that came before the HGP have a life span of only 20 years so they are expiring quickly) – there is a precedent here that may cause future discovery to be held hostage thorough misused patent law. In the approximately 80 pages of current patent law, the team “discovery” is used only three times. Therefore it should not be a significant effort to amend this law with more precise language that supports the scope of invention – rather than greed.

JB

References and Sources:

ACLU (2009), Article: ACLU sues over patents on breast cancer genes, CNN, Retrieved May 16, 2009, from: http://www.cnn.com/2009/HEALTH/05/12/us.genes.lawsuit/index.html

Burger, Chief Justice. (1980). Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, United States Supreme Court, June 16, 1980, 447 U.S. 303, 206 USPQ 193; Retrieved May 16, 2009, from: http://digital-law-online.info/cases/206PQ193.htm

Human Genome Project (2009). Human Genome Project Information, Oakridge National Laboratory, Retrieved May 16, 2009, from: http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml

Landau, E. (2009). How human genes become patented, CNN, Retrieved May 16, 2009, from: http://www.cnn.com/2009/HEALTH/05/13/genes.patent.myriad/index.html

US Patent and Trademark Office (2009). United States Code Title 35 – Patents, Appendix L Patent Laws, Retrieved May 16, 2009, from: http://www.uspto.gov/web/offices/pac/mpep/consolidated_laws.pdf