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a bio blog about genetics, genomics, and biotechnology
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.
Update: Myspace auctions its users’ data. Is this the future of the left side of the medical record bell curve?
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 without somehow losing money.
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 by 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. Probably both.
People, when you think CMS, think: “IRS,” not: “FREE $$$ CASH NOW PRACTICE FUSION! *BROFIST*”
Fact: CMS does not write free checks to idiots just because some facebook goldrushing blueshirt salesbros TOTALLY “did the math for you.”
But BRTO! GOOTA GET SWEET SWET STIMULUS CAHS! !!! “MY DRUD!REVOLU!T!, um… YAH $44000 FITH THE MAN EMR FIGHT …….. PRACTICE FUSION YAH MEDICINE WE SELL YOUR DATA BECAUSE REVLUTION … WIRED! magaza… um, woah, can I crash with like you, dude, or somethi PRACTICE FUSION ok…. dude…. seriously, like, need a to crash palce like, dude….”
Bottom line: if your doctor can’t do it, you can’t either.
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 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 letter satisfies the discovery of noncompliance as specified in 42 USC § 1320d-5(b). The law provides that your office has 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 any individual 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.
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Think Gene at Technorati
