If I had my way, every primary care patient in my office would have a genomic test. But, I can’t: the 23andMe contract explicitly forbids its medical use.

Again: I run a medical office. I can’t even legally use my own 23andMe report in my own medical office for my own health —let alone endorse its use for patients.

Imagine this scenario: a patient comes into the medical office with a 23andMe report. The doctor uses the report to, for example, prescribe an alternative to Plavix because the patient is at risk for thrombosis but —like 17% of people and as warned by the FDA— the patient does not metabolize Plavix to its active form according to 23andMe.

BOOM! That patient coerced that doctor into malpractice liability. Section 3 of 23andMe Terms of Service: “The Services Content is not to be used, and is not intended to be used, by you or any other person to diagnose, cure, treat, mitigate, or prevent a disease or other impairment or condition, or to ascertain your health.”

The worst of this is that 23andMe ACTIVELY INSTRUCTS its users to violate this clause —not only personally, but to also implicate their medical doctors in crime.

And the doctor is trapped: he can respect the law and alienate the patient, or ignore the law and appease the patient.

That’s your “health empowerment revolution”: more kafkaesque legal games, more parasitic licensing contests, more marketing, more wasteful testing, and more money to a few celebrities while the people who actually learn the science and do the work get the blame and the bill.

You know, I’m all for the hacker ethic. But if you hack the system, it has to be for the greater good —the greater system. Otherwise, that hack is just called “evil” —and that’s what this entire 23andMe adventure looks like to me: garden-variety, ordinary, boring, stupid evil.

23andMe: We trusted you with beautiful work, and you mashed it into useless noise. That’s the real crime here.

In fact, that’s why I’m in this horrible business of medical practice management at all. Years ago, I trusted you to do the right thing. I thought that genomics would be obvious common practice for sure, and I wanted to be there when it was. But no. You had to play popular and fuck it up for everybody.

The 23andMe Terms of Service contractually binds its users to the following clause:

The Services Content is not to be used, and is not intended to be used, by you or any other person to diagnose, cure, treat, mitigate, or prevent a disease or other impairment or condition, or to ascertain your health.

However, this contract is imposed by 23andMe to the public in bad faith because 23andMe actively promotes its users to violate this clause.

For example: the 23andMe test includes a report about the blood thinning drug Warfarin (sample report) which includes medical advice about Warfarin dosing based on test results. In this example, the Twitter user “attilacsordas” electronically messaged the company 23andMe:

@23andMe sent my Warfarin Sensitivity Report to a cardiologist to enlighten her,if most @23andMe users could do the same: a nice campaign…

and

@23andMe 1st I showed her the Warfarin page on the iPhone,she was really surprised that such service exists,then sent her the printed report

The following messages indicate a violation of 23andMe user contract: “The Services Content is not to be used, and is not intended to be used, by you or any other person to diagnose, cure, treat, mitigate, or prevent a disease or other impairment or condition, or to ascertain your health.” In this example, the user “attilacsordas” allegedly coerced a cardiologist into jointly violating the 23andMe contract when he sent the report to “enlighten her” which presumably means “to be used in warfarin dosing.” The use of a 23andMe report for Warfarin dosing by a cardiologist is a clear example of to “diagnose, cure, treat, mitigate, or prevent a disease or other impairment or condition, or to ascertain your health.”

23andMe responded to this message by endorsing and broadcasting it to its users and to the public as a “retweet” or “RT” on March 17th, 2010 as follows:

RT @attilacsordas sent my Warfarin Report to a cardiologist to enlighten her, if most @23andMe users could do the same: a nice campaign…

Thus, I allege that 23andMe actively promotes violation of Section 3 in the 23andMe Terms of Service to its contractually bound users and to the general public.

Commentary

What is the legal precedence for a contract imposed upon the public in bad faith for commercial advantages with material liability to public health in order to avoid the regulations of drugs and disease control in the United States? Internationally? Per state? Per… provence?

Maybe Dan Vorhaus could advise.

I’d also be interested to learn about the liability of the lawyers contracted with 23andMe regarding the composition and approval of this contract and related company policy.

23andMe Terms of Service, Section 3

Description of What the Services Are and Are Not: 23andMe Service Is For Research and Educational Use Only. We Do Not Provide Medical Advice, And The Services Cannot Be Used For Health Ascertainment or Disease Purposes

The genetic information provided by 23andMe is for research and educational use only. This means two things. First, the genetic information you receive from 23andMe is based on scientific research, and cannot be relied upon at this point for diagnostic purposes. Genetic discoveries that we report have not, for the most part, been clinically validated, and the technology the laboratory uses the same technology used by the research community has also not yet been validated for clinical utility. Second, by your participation in the 23andMe service you contribute your genetic information to our research effort to study various aspects of human genetics in an attempt to better understand the human genome. In addition our service enables you to contribute other personal information towards research as well. As a result, our Services, including but not limited to text, graphics, images, information relating to (a) My Health and Traits, including the 23andMe Odds Calculator, technical reports, MD’s Perspectives, research timelines; (b) Genome Labs, including genetic comparisons, family inheritance and your raw data; (c) Ancestry, including maternal ancestry, paternal ancestry, global similarity, and (d) other material contained in our Services (“Services Content”) are for informational and educational purposes only. The Services Content is not to be, and is not intended to be, used for any diagnostic purpose and is not a substitute for professional medical advice. The Services Content is not to be used, and is not intended to be used, by you or any other person to diagnose, cure, treat, mitigate, or prevent a disease or other impairment or condition, or to ascertain your health. You should always seek the advice of your physician or other appropriate healthcare professional with any questions you may have regarding diagnosis, cure, treatment, mitigation, or prevention of any disease or other medical condition or impairment or the status of your health.

23andMe does not recommend or endorse any specific course of action, resources, tests, physicians, drugs, biologics, medical devices or other products, procedures, opinions, or other information that may be mentioned on our website. As explained on our website, 23andMe believes that (a) genetics is only part of the picture of any individual’s state of being, (b) the state of the understanding of genetic information is rapidly evolving and at any given time we only comprehend part of the picture of the role of genetics, (c) only a trained healthcare professional can assess your current state of health or disease, taking into account many factors, including your current symptoms, if any, and (d) our testing service is not licensed by the relevant state and federal authorities for genetic testing conducted for health and disease-related purposes. Reliance on any information provided by 23andMe, 23andMe employees, others appearing on our website at the invitation of 23andMe, or other visitors to our website is solely at your own risk.

I run a primary care medical practice.

Assume: the 23andMe test is an excellent clinical tool. I want to include it as common medical practice.

Problem: all “consumers” of  the “23andMe Service” are bound by the following contract:

23andMe Service Is For Research and Educational Use Only. We Do Not Provide Medical Advice, And The Services Cannot Be Used For Health Ascertainment or Disease Purposes

Question: How do I legally and ethically use a 23andMe test in my medical practice when I’m contractually bound not to?

Answer:

Oh. Right. I’m supposed to “ignore” that part of the contract.

Law for us but not for you, right?

Patients helped by 23andMe: zero —and by design! You never wanted to help patients! You always wanted to be popular!

…Well, I do see that you’ve invented a great medical test. And, I do see that you’ve designed a great medical report. And that’s worth some considerations. But I do have one question. When you go to your next little company, you will be selling software to medical doctors as medicine, and I image you’re going to take off that handsome looking 23andMe brand of yours— and nobody will know how bad you tried to fuck doctors. Now that… I can’t abide.

Faking Reasonable: The Null Hypothesis

Meanwhile, Navigenics still pushes their useless tests on doctors:

The contents of our Site …are for informational purposes only and are not intended to substitute for professional medical advice, diagnosis, or treatment.

You should not ignore professional medical advice or delay in seeking it because of Your Report or any other Content. Furthermore, you should not interpret Your Report or any other Content as recommending any specific treatment plan, product or course of action.

In other words: there is no difference between a treatment and the control. Well, it doesn’t take a Ronald Fisher to publish Navigenics latest invention: The Magic 5% Gene License. Oh boy! Gene licences! Gotta catch ‘em all!

But nobody trusted Navigenics to change the world. At least Navigenics didn’t betray me.

it will be because Anne felt like it

I’d say the Brins pulling out their money while firing all the employees qualifies as “felt like it.”

Dr. Steven Murphy writes an excellent post about his stance in medical genomics and why he does not support today’s “Direct to Consumer” genomic industry. Highlights:

Medicinally used genetic tests, whether DTCG or not, should be represented and treated as Medical Tests…

Medical Genetic tests should be regulated according to the laws of each state/country…

Simply stating your tests are “nonmedical” does not make them “nonmedical” especially if they have a long history of being used medically…

I know many people who read this website do not like Dr. Steven Murphy. But that is a damn fine argument, and the truth is, Steve believes in personalized medicine so much that he built an entire medical practice to do it. Sick people come in, and healthy people come out. Everyday. So, you’re a “personalized medicine” advocate? What did you do? Link from your blog? Raise awareness? How many patients got medical help from you? Zero? “but… um, I helped contribute awareness and advocate….” Yah… nothing. That’s what I thought.

I support Steve. You may not like his online persona. You may not like the personality stereotype of all doctors. But remember: nobody liked the “personality type” of “electrical engineers” in the 1970’s, either.

Aside: and all this hate toward Myriad: listen, you may not like Myriad. But they have been healing patients for decades before you even knew what DNA was. Have some respect. Oh, so you don’t like “gene patents”? Me neither. But, take it to court… and I sure as hell hope you have better arguments than “it’s like looking in the mirror” and “if something new is created, then you can’t make diagnostics.” Cut the “oh some evil company wanted to bill me a couple hundred dollars for a medical test boo hoo” trial-by-mob bullshit. Yah. My business is medical operations. You want a boo hoo story? I have real boo hoo stories for you. Run a decent case and keep the half-assed sob stories to yourself.

There are many good people in Silicon Valley genetics doing great work. They don’t deserve to be dragged through the mud on your manic sleigh ride across the Internet. Linda: please shut up.

(John Mackey is the CEO of Whole Foods who created a federal regulations scandal by posting comments on the Internet)

For example:

When DNA means do not ask

Gene Ager (alias for Linda Avey) wrote:

It’s fine to hear your opinion of whether you’d choose to be tested but it’s just your view. I have no doubt that you and the people who share your perspective will some day greatly benefit from the more open-minded individuals who step forward and participate in these early days of genomic discovery. So, with all due respect, keep your head buried in the sand while the rest of us (yeah, mostly in the US) blaze new trails. Thank you, Glenn!

and

The Life and Times of Lilly Mendel (Linda Avey’s blog)

So if Andrew Pollack decides to take a swipe at this fledgling industry, he won’t be the first, or the last. It’s an easy bandwagon to jump on, along with the other nay-sayers, but there’s a growing wave of data-empowered people who won’t bat an eye, and who may just help lead us into a new age of personalized health that Andrew himself may find quite beneficial. Now that’s something to write about.

and a Google image search is a bonza of embarrassing photos:

Keith Grimaldi of Eurogene writes in response to a comment thread at Daniel MacArthur’s Genetic Future:

@AndrewYates
“Is there a law in the UK about providing medical advice without a medical license?”

I don’t understand your (and Sherpas) issues with what is medicine and what is not. Is it actually against the law to give medical advice if you are not a medical doctor? Is it against the law to give it DTC widely and freely as many government sites do (NHS, CDC, NIH, etc)? What about the pharmacist who advises me on medicines? What about buying ranitidine DTC in the supermarket? Where does medicine begin and end? What are the terms that define what has to be limited to a medical doctor and transmitted by the doctor directly to the patient? It seems that a lot of what you and Steve talk about as “doing medicine” apply to a whole load of stuff that is routinely done by non-medics, with no particular problems.

What makes 23andme with their (non-invasive) test “doing medicine” compared to say the NCI Breast Cancer Risk Assessment Tool? Especially as we are often reminded that classic risk assessments are more accurate than genetic tests. If that is the case then why is it not a problem that there are so many sites offering risk assessments with these more accurate algorithms, why are they OK DTC but genetic testing is not? What is the fundamental difference?

As far as I can see none of the DTC companies are making diagnoses or actually advising treatment – that I would agree is generally the realm of the medical doctor, but not always, unless it’s against the law for my pharmacist to advise me to take a ‘flu medication).

The lines are blurry and the regulation is poor but it’s not clear why DTC is being singled out for your collective attacks. You may not like the marketing methods (I would say that you certainly don’t), you might not think them useful as tests, on these I can understand your reasons. I don’t understand your reasons for thinking that it’s an illegal activity and that only medical doctors should be allowed to do it.

“why DTC is being singled out for your collective attacks”

Because genomics belongs as common medical practice, and the way to achieve that is to shed the groupies and get serious about how to actually apply genomic medicine in actual practice.

“Is it actually against the law to give medical advice if you are not a medical doctor?”

Yes.

Think: law. Can you give legal advice if you are not a juris doctor? That depends on how you represent yourself and what kind of contracts you solicit for the advice you “give.”

“Is it against the law to give it DTC widely and freely as many government sites do (NHS, CDC, NIH, etc)?”

• Medical science itself is not medical advice. An analogy is that a law citation is not a court order.
• It’s not unlawful for an agency of law to publish medical science —even if edited for “layperson’s consumption.”
• Merely “publishing public medical science on a website” does not constitute a patient relationship between the reader and the publisher.

“What about the pharmacist who advises me on medicines?”

What a pharm tech can tell you over the counter is more aggressively regulated than anything in a medical office. Further, (and I’m going to get in trouble for this someday but) Pharmaceutical salespeople are specifically selected for their complicit ignorance so that they don’t accidentally disclose protected information about the drug. If you want to amuse yourself, pull out wikipedia in front of a drug rep and start telling them about their own drugs in front of a medical doctor.

“What makes 23andme with their (non-invasive) test “doing medicine” compared to say the NCI Breast Cancer Risk Assessment Tool?”

“Invasive” is a matter of relationship, not necessarily physical contact. “Information” itself cannot form a relationship with an individual to produce medical advice in the same way that the source code of software itself cannot to produce results. Note: “non-invasive” actually means “less invasive” with the implication being “less invasive than traditional surgery.”

Also: It’s not unlawful for an agency of law to publish medical science —even if edited for “layperson’s consumption.”

Commentary:

I am receptive to learn how 23andMe and Navigenics actually intended genetics for real application in medicine when they explicitly forbid that practice in their contract.

Yah, I got the memo: Everybody just chill, this is for the greater good.

Yah, well: I didn’t see any greater good. I just saw new people telling me what I should be “free” to think. I just saw celebrities gorging on cake while everyone else scrambled for bread. And I saw the same pharma psyops and the same condescending licensing games —just new people, and this time, they had the gall to tell me that “this is freedom.”

Now we all can see that the dream is dying, and we all can see you just wanted to buy horses and play tin soldiers. Hurry up and die so next generation can step on your corpse without tripping. Nice website.

Or not: Maybe 23andMe isn’t medicine. But then, Myriad BRCA test is not medicine, either.

Update: cross posted by Dr. Steven Murphy at Gene Sherpas.

Myriad’s BRCA breast cancer genetic test “Multisite 3 BRACAnalysis” is the same test as 23andMe’s BRCA breast cancer genetic test “BRCA Cancer Mutations (Selected).” Both services test for the same mutations to produce the same diagnosis medical diagnosis justified by the same medical research.

See the exhibit above which depicts genetic test results for 23andMe’s BRCA genetic test and Myriad BRCA genetic test.

The contested 23andMe claim is published by 23andMe online at 23andMe’s Terms of Service, Section 3.

Contested 23andMe Claim

23andMe Service Is For Research and Educational Use Only. We Do Not Provide Medical Advice, And The Services Cannot Be Used For Health Ascertainment or Disease Purposes.

The objections to this claim are that this same test is already defined for use as “health ascertainment or disease purposes” and that the use of this test is already included in standard medical practices in the United States. One implementation of this test for use as “health ascertainment or disease purposes” includes the Myriad “Multisite 3 BRACAnalysis” test.

Thus, either the 23andMe “BRCA Cancer Mutations (Selected)” test is medicine, or the the Myriad “Multisite 3 BRACAnalysis” test is not medicine.

Note: The 23andMe and Myriad reports depicted in this exhibit have been reformatted for publication on the Internet. Email me if you would like an unformatted copy of either report depicted in the display.

From the response to Practice Fusion: Class D Felony?

We completely stand behind our data protection policies and unique business model. We take this a step further as one of the only EHR vendors to undergo third party security audits.

It is unlawful “EHR vendors” to not undergo regular security audits as part of standard practices for handling electronic protected health information. Would you please list the following EHR vendors that you and have publicly stated as knowing to be practicing unlawfully?

Further, the “security” of your systems is not relevant to your explicit practice and intent to disclose protected health information for commercial advantages. Protecting your unlawful practices to exclude other criminals does not make your practices lawful.

Finally, really? Of all the health record systems for all the millions of people in the United States over decades in all the hospitals and in all the medical centers and in all the universities, you, Practice Fusion, are “one of the only” vendors to “undergo third party security audits?” Really? No other vendor has every thought of securing their protected health information? You’re the leaders? In data security?

Yah, Ok.

I mean, somehow you’ve managed to convince people that the federal government will give you “stimulus cash” for using your EMR, which is a complete lie. Somehow you’ve managed to convince people that you’re the leaders in electronic medical records. No, not Epic, not even Citrix or Cerner… no, what you do is “revolutionary.” Really? There is nobody else in the entire world who has thought to put health records on a server and share them over a network. Nobody? You’re the market leaders?

And then, somehow you’ve managed to convince people that it’s GOOD that your DOCTOR exchanges your TOP SECRET PRIVATE MEDICAL DATA AND DEMOGRAPHICS for “free software over the Internet.” Somehow, you’ve convinced a demographic of people who are paranoid about even using the same password on two different websites that, yes! Selling patient data to an opaque web of “people who want to buy private demographics” is good!

Ok, engineers of Silicon Valley: you know how “social media” business works. You know that those banner ads are complete scams. You know that you just hold your nose and send the data to make the numbers —or else you know somebody else will. Even Max Levchin of Slide publicly complained about the seediness. Of Paypal. Max. The man who made it through Paypal had trouble stomaching the cottage industries of Facebook. But that was Buyer Beware, right?

But Practice Fusion… here we have a green fields where we can really do something great for something that really matters. And Practice Fusion, they pump their Retard Strong VC Cash through the PR machine and bizdev rackets with the EXPLICIT INTENT to resell other people’s medical records … not because you, the patient consented, but because they’ve conned your doctors —the people you must trust with all your most private secrets— into the Social Media goldrush and the “free stimulus cash from the Government!” pitch. I mean, CNN even PUBLISHED a headline reading: The next tech goldmine: Medical records.

And you APPLAUD them? You celebrate? Hooray! It’s everything we hate all over again, but maybe this time we’ll strike gold!

Not me. The buck stops here.

In review, “Patent disputes could trip up genome wide scans for disease” Nature Medicine:

My stance is that biochemicals are media. Thus, the physical media —your DNA— are your physical property. The data encoded by the media —your DNA sequence— is your property under copyright. The DNA sequencing process and machinery may be patentable property. The meaning and interpretation of the data —your DNA test results— is like software or music. It can be copyrighted or licensed, but it should not be patented.

Analogy: DNA molecules as CDs

Imagine a CD. I speak “Hello, my name is Andrew Yates” into a microphone, I create an audio recording of my voice, and I burn that recording onto a CD.

I own the CD.

I own the copyright to the information encoded on that CD.

I cannot patent “Hello, my name is Andrew Yates.”

I cannot patent the meaning of “Hello, my name is Andrew Yates.”

I can patent CD readers. You may not be able to sell CD readers without a license from me.

However, my CD reader patent does not extend to whatever you record on your CDs —even if I claim to own all means of reading all CDs. Further, a patent is a right to exclude. You can read your CDs however you like until I officially tell you that you can’t.

Map: Your DNA sample is the CD. The sequence of your DNA is “Hello, my name is Andrew Yates” voice recording encoded in the CD. The CD reader is the DNA sequencer. The medical report from your DNA is your interpreted meaning of “Hello, my name is Andrew Yates.”

Reduce: Now, I never want to hear this “mirror” analogy ever again.

Vulture Capital: Navigenics

More from “Nature”:

Navigenics, which includes an indirect test of the patented Alzheimer’s gene APOE, has proposed a royalty-based model that reflects the relative contribution of the licensed gene or single nucleotide polymorphism to the overall value of the service. The company envisions stacking royalties such that they do not exceed 5% of their sales.

Translation: we should all agree to unintelligible license contracts so we can level up as portfolio license pokemon!

Uh oh, a wild startup appeared! Navigenics, I choose you! Navigenics used APOE. It was super effective! startup is confused. startup hit itself in the confusion! startup has fainted. Vulture Capitalist wins!

Athena Diagnostics, which has exclusive rights to the patent for APOE, says it has not come to any conclusions regarding such opportunities.

Translation: no.

Commenter “AnneW” at Genetic Future writes about Dr. Steven Murphy’s alleged claims against 23andMe:

…Prove us wrong Steve. How many doctors need to offer/endorse/whatever a test before you like it? How many publications in what journals? What is your criterion if anything?

Posted by: AnneW | March 5, 2010 4:09 PM

“AnneW,” how many doctors need to offer/endorse/whatever a test before you dismantle your doublespeak?

23andMe Terms of Service

3. Description of What the Services Are and Are Not: 23andMe Service Is For Research and Educational Use Only. We Do Not Provide Medical Advice, And The Services Cannot Be Used For Health Ascertainment or Disease Purposes

Nobody bashes Steve but me. Cut the bullshit.

Practice Fusion:

You get $44,000 for using an EHR,

Practice Fusion is entirely free.

Do the math.

Ok.

Lie: You get $44,000 for using an EHR

Fact:  [ARRA § 4101] If an “eligible professional” is a yet-undefined “meaningful EHR user,” they could quality for Medicare and Medicaid “incentives” of “an amount equal to 75 percent of the allowed charges under this part for all such covered professional services furnished by the eligible professional during such year” from the to-be-established “Federal Supplementary Medical Insurance Trust Fund” not exceeding:

• 2011: $15,000
• 2012: $12,000
• 2013:  $8,000
• 2014: $4,000
• 2015: $2,000
• 2016: $0

Then, Medicare and Medicaid will penalize you up to 5% by the end of the decade from their rates which are already the lowest in the industry —unless you can prove to them why they shouldn’t. You probably won’t.

Commentary:

There is no $44,000.

Maybe you can apply for a few extra thousand dollars in medicare disbursements over several years if you are particularly sophisticated and already participate in Medicare or Medicaid.

Most practices will lose significant gross revenue from HITECH penalties by default.

Anybody who says otherwise is trying to sell you something dubious —probably more consulting to buy more consulting about how to save money through hiring consultants.

If $15,000 in 2011 is enough to matter to your practice, you are either a clueless medical student or about to go out of business.

The statements made in this post are not an accurate representation of the license agreement or the privacy policy that Practice Fusion users accept upon logging into the service. In particular, the section, template letter to medical provider, is a complete misrepresentation of fact.

You don’t need to convince me. Convince the judge. Convince the Attorney Generals in all 50 states. Then, convince the doctors that trusted you that the legal exposure they’ve incurred on your behalf is justified. Then, convince your investors why you are spending millions of their dollars in bizdev to accumulate a “market share” that you can’t defend in court. Then, convince the Cerners and the Epics why they should pay to acquire you when they can simply hire their own team of engineers to copy your product.

Practice Fusion’s data security and privacy policies are not the topics of contention. Practice Fusion discloses protected health information for commercial advantages. That’s exactly the definition of “targeted advertising based on your medical records.” I have a good faith belief that the practice opposed is unlawful. It’s that simple.

Ask your grandfather or the lady who teaches your children or your next door neighbor what they would think if their medical doctor exchanged their private medical records to marketers and researchers in exchange for free internet website services.

Really? Joe American’s prostate exam and INR is the “next tech goldmine“? All behind his back? On the computer? Over the Internet? To more smarmy marketers, lifestyle coaches, and insurance middlemen? While they themselves are worried about paying the bills and jobs for their kids?

“Oh! But it’s like Facebook! For bowel cancer!”

I’ll tell you what: the real “next goldmine”? —you in red state court.

Did you know that you can be served by email in Texas?

For the love of God: 23andMe was a little risque, but now every crack comp sci fresh from Stanford is falling over to be the Zynga of EMR? IT IS NOT 1997. That was 13 years ago. 13 Years. The world is not the same. There will not be another dot-com boom. You are not 16. You are not liberating indi rock from The Man. You are 30. You are entrusted with the most private informatics of your fellow citizens. Have some respect.

The millions of dollars you spent on SoHo parties: you could have paid the salaries of a team of doctors for years. Then, when parties don’t convince the masses, you stamp out a CRUD apps, pop another quarter in the PR machine, and strut around like, OK, THIS TIME you’ll be the saviors of American Healthcare. Why? Because you play video games at work? And that makes you revolutionaries?

Shame on you. Just… how do you people stand to be around each other? XBox?

“The Future of a Radical Price” indeed.

Practice Fusion:

Practice Fusion is an ad-supported product. Practice Fusion’s medical advertising placements are non-intrusive, completely private and never pop-up. If you decide you don’t like the ads, you can switch to an ad-free version for a $100 a month per practitioner at any time.

42 USC § 1320d-6 (b)(3)

if the offense is committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, be fined not more than $250,000, imprisoned not more than 10 years, or both.

Scope of Criminal Enforcement Under 42 U.S.C. § 1320d-6

For the foregoing reasons, we conclude that covered entities and those persons rendered accountable by general principles of corporate criminal liability may be prosecuted directly under 42 U.S.C. § 1320d-6 and that the “knowingly” element of the offense set forth in that provision requires only proof of knowledge of the facts that constitute the offense.

New HITECH Enforcement: Effective 17 February 2010

111 H.R. 1 § 13404. Application of Privacy Provisions and Penalties to Business Associates of Covered Entities

(b) …shall apply to a business associate described in subsection (a), with respect to compliance with such subsection, in the same manner that such section applies to a covered entity, with respect to compliance with the standards…

(c) In the case of a business associate that violates any provision of subsection (a) or (b), the provisions of sections 1176 and 1177 of the Social Security Act (42 U.S.C. 1320d-5, 1320d-6) shall apply to the business associate with respect to such violation in the same manner as such provisions apply to a person who violates a provision of part C of title XI of such Act.

111 H.R. 1 § 13410. Improved Enforcement

(d) Enforcement by State Attorneys General

…in any case in which the attorney general of a State has reason to believe that an interest of one or more of the residents of that State has been or is threatened or adversely affected by any person who violates a provision of this part, the attorney general of the State, as parens patriae, may bring a civil action on behalf of such residents of the State in a district court of the United States of appropriate jurisdiction

111 H.R. 1 § 13411 Audits.

The Secretary shall provide for periodic audits to ensure that covered entities and business associates that are subject to the requirements of this subtitle and subparts C and E of part 164 of title 45, Code of Federal Regulations, as such provisions are in effect as of the date of enactment of this Act, comply with such requirements.

Template Letter to Medical Providers

[Medical Provider] has contracted with third party Practice Fusion to disclose Protected Health Information (PHI) for commercial advantages including medically relevant advertising, marketing, and research in exchange for free telecommunication and Health Information Technology (HIT) services including Electronic Medical Record (EMR) search, storage, and transmission. This contractual agreement cannot be reconciled with federal law and PHI policy which forbids such a disclosure by a covered entity and its business associates. This violation is subject to federal civil penalty as per 42 USC § 1320d-5.

The witnessed receipt of this message satisfies the discovery of noncompliance as specified in 42 USC § 1320d-5(b). The law provides that you 30 days to comply without imposed penalty on the first date the person liable for the penalty knew that the failure to comply occurred.

Statement of Non Retaliation

This publication is federally protected. 45 CFR § 160.316

A covered entity may not threaten, intimidate, coerce, harass,discriminate against, or take any other retaliatory action against anyindividual or other person for … (c) Opposing any act or practice made unlawful by this subchapter provided the individual or person has a good faith belief that the practice opposed is unlawful, and the manner of opposition is reasonable and does not involve a disclosure of protected health information

Commentary

“The highest return on your investment because Practice Fusion is free.”

The biggest unexpected expenses for small medical providers are legal compliance and forced obligations to vendors providing services beyond the technical sophistication of  local staff. I disagree that Practice Fusion “is the highest return on your investment” because it’s illegal and that’s expensive.

It’s also a bad idea.

Example: Greenwich Hospital spent $225 million for an electronic systems upgrade this year, and Greenwich Hospital is already one of the most technologically sophisticated hospitals in the nation. How does the return on Greenwich Hospital’s $225 million investment compete with Practice Fusion when Practice Fusion is free? Know: Regionally-aggregated Protected Health Information is the most valuable information in the world. It is the most complete demographic information of all people. It includes life history financial details rivaled by the IRS. It is professionally audited by medical doctors, government agencies, and health institutions from birth until death.

$225 million is value difference between sharing control and keeping control of Protected Health Information —per hospital.

Protected Health Information so valuable that the federal government makes it a Class D Felony to disclose it unless absolutely necessary.

And companies like Practice Fusion —and their advertisers— want all that Protected Health Information in exchange for “free use” of software that’s about a $300k and 6 months of software contract in Adobe Flex to build yourself.

As proudly published by Practice Fusion, as featured in Wired Magazine, as announced on Practice Fusion’s blog —Practice Fusion’s Intent:

Sell access to your data.

Aside: Today, a CTO of a start up company that I like asked me what I thought of Practice Fusion. Answer:

The first rule of healthcare is that you do not disclose healthcare. The second rule of healthcare is that everybody is stupid. That’s why healthcare is 1/6 of the national economy. Everybody is just too stupid to illegally sell their business for $100 to internet advertisers. They’re too busy earning 8% on gross revenue sending faxes.

Yes, it can be done, and yes people are doing it.

PCR Machine

Hood

Various reagents and chemicals (more…)

You want a policy that will force health care to work? Fine. This will work.

All licensed medical third-party payers must publish a public, free, unrestricted web service from which anyone can simulate any and all medical insurance decisions. These insurance decisions include:

• Determination of coverage and all policy purchasing qualifications
• Premiums, co-pays, deductibles, and all other payer financial details
• Reimbursement per submission, necessary medical documentation and justification, and all other medical provider-submitted details

No health insurance decision can be executed that cannot be publicly simulated via this web service in advance. Any simulation can be authorized by a patient policy holder and medical provider to become an executed health insurance decision. All documentation necessary to simulate all possible decisions must be published on a public, free, unrestricted website.

Each submission optionally includes a simulated date of submission. The web service will return the decision as of that date. In effect, one could map a decision given a submission from now each day back until the date of service implementation. Submissions without a date specified will be assumed to be for the current date.

Any health insurance decision that does not comply with this policy is grounds for a declaration of Policy Corruption by the federal government. Continued violations will result in the forced restructure of the third party payer. This restructuring will resemble an FDIC restructuring an insolvent bank, including a federally-insured ceiling policy in the event of an insurer failure.

Simply: given this submission, what do you do? In a payer contract, any inability to give an absolute answer to this question immediately can only be for two reasons:

• flagrant incompetence (bad)
• fraud (bad)

Why would there be any ambiguity? Think: there is no medical decision making. There is no clinical participation. There is no interaction with patients, the human body, or the environment. It’s simply: discrete data in, discrete data out. And: SOMEHOW decisions are being made. Are these decisions made by:

A) a consistent, understandable, fair, contract of discrete cause and effect? (good)

or

B) “some guy” making some arbitrary decision about who gets what whenever? (bad)

Because if you want A (good) and not B (bad), this test enforces it with an obvious true / false test without divulging trade secrets or private health information and without snowing regulators. (i.e. the Law and Order “we’ll fill your office with boxes of incomprehensible paper forms —that will teach you to mess with the Bureaucracy!” trick) And there is no need for new regulatory committees, laws, and policies. Any medical provider could very simply verify the integrity of the system: here’s what we submitted, here’s what you said you would do, did you do it? Y/N.

Further, it solves the incentive to health care providers to submit their claims electronically, and it stimulates entrepreneurs to build high-tech businesses using the new wealth infrastructure.

And finally, it’s a policy that can actually be DEFINED and ENFORCED to create real WEALTH and directly SOLVE THE PROBLEM of modernizing American health care by empowering the public with concrete data and services —rather than some vague and useless policy like “it is illegal to be inefficient, and you (somebody?) must complete all these forms to prove it.” That crap only makes more Yahbles. Yahbles are intellectual toxins that gradually weighs us down and makes our institutions sick. The Solid State health system clears the air and plants seeds of innovation and productivity.

I use jargon. Here is some of it:

Yahble

Yet Another Huge Binder of LegalesE

These are binders of documentation, policy, plans, and law that you can’t throw out Or Else, but neither you nor anyone else ever reads, and generally are entirely worthless in practice despite being Very Important in theory.

Yahbles collect in the system like lead or mercury. Lovingly, they are passed along the foodchain until everybody dies of heavy metal toxicity induced bureaucratic insanity.

Government agencies and consultants love to make Yahbles. When you force a pile of hot, sweaty consultants into a small, closed space overnight, expect a fresh steaming new Yahble in the morning, there! revealed to thee yonder in the glaring flouresent din of 7:48AM upon ye humble coffee-stained hard white plasix conference table.

It’s also understood that Yahbles are gradually churned into existance from the bowels of The Back Office, but like invention of a new race or ethnicity, nobody has ever witnessed the complete Yahble evolutionary process of a generally accepted Yahble outside of an artifically imposed environment.

HIT

Health Information Technology

This is a common industry term in health-related information technology. In practice, it refers to all the information transmission and processing generally associated with “The Health Care Industry” that doesn’t really work well or that isn’t well understood. Stuff that actually works is just called by its real name, or generally: “software.” Note: HIT does make for cool-sounding portmanteau like “HITman” and “HITbox.”

For example:

Mozilla Firefox web browser: firefox, or just “the browser”

Command-Response terminal simulation system to display text and pictures from a server on another machine over a network that only runs on Windows XP and requires the installation of several vendor-specific plug-ins: HIT

===

Linux: linux, or just “the server”

???: HIT

===

email: email

web 2.o patient physician medical communication cloud computing enterprise suite: HIT

Bubblecon

Internet bubble convention

Bubblecon is some marketing convention for some new hyped technology or industry. Attending bubblecons is a popular means by which one may accumulate a significant collection of business cards titled “CEO,” “Founder,” and “President” —and sometimes, all three at once!

Fact: nobody has ever gotten funded because they attended a bubblecon. I did get laid, though. So YES: in my rigorous scientific sampling of exactly myself, you are more likely to get LAID by a GIRL at a NEW TECHNOLOGY BUSINESS CONVENTION than you are to get your tech startup funded with odds of 1/0 == infinity %. That’s science.

BIZDEV!

Business Development, often predicated by “Vice President” (VPBIZDEV!)

BIZDEV! is always appended with an exclaimation point.

BIZDEV!s love bubblecons because they are concrete and documented evidence of attendance at a work-related events. That’s because documented attendance means work, which is why they are the CEO and visionary entrepreneur, and definitely not bullshit, which is why they are not delusionary aging jock losers that couldn’t cut it at a regular sales job. This Very Important Job is colloquially known as “networking,”and it is the Most Important Job at all startup companies. Also, see “ideas” and “twitter.”

Solid State

in a HIT context, it means a unit of health care organization that is maximally automated with the utmost elegance and efficiency. It is the platonic ideal of how “things should work”. Generally, see Solid State.

The fashion in health care’s “policy sphere” is to fix logistical problems by making having the problem itself illegal. That’s… not going to work. Consider, from Forbes: “How Safe Are Your Medical Records?”

Notification laws are slowly changing as part of the stimulus bill, which has mandated new accounting rules. Physicians will now be required to track disclosures of a patient’s medical information and disclose security breaches in some cases. The new rules won’t go into effect until 2014.

Really. So, if problem is a policy lapse due to an bloated, unresponsive, overloaded health care bureaucracy, then the solution is to force all medical providers to keep Yet Another Huge Binder of Legalese (Yes, the dreaded Yahble) for which you are Legally Liable to Keep A Copy In Your Office At All Times

Genius! I’ll just organize another meeting and invent another acronym. That will be ten million dollars to my Health Care Information Technology consulting firm, please. (Unless, of course, you don’t mind being declared a Federally Deficient Medical Provider. Can you really afford that legal liability? Oh, by the way, we noted in our report that your hospital has a ten million dollar budget discrepancy this year. We advise a hiring freeze in IT, investment in a clock-punch payroll system for physicians, and cuts in “loss-leading” non-surgical, non-specialist departments like primary, preventative, and hospice care.)

Listen: it’s silly to make things that are already illegal “double illegal.” For example, it’s already clearly against “company policy” to steal cash from the cash register at a medical office —not to mention illegal. There’s no need to Really Really say so in a Yahble. That’s true for cash; that’s true for medical records.

It was illegal in Soviet Union to be inefficient, too. That didn’t make their institutions more productive. That just gave anybody an excuse to prosecute political and economic deviants because, hey, there’s policy for everything. Everybody’s already criminal. We just haven’t gotten around to prosecuting you yet —and do you really want to fight this battle? (ref: U.S. intellectual property law.  ever been accused of “trademark” or “patent” infringement? you’d understand)