Breaking News: Congress Wants to Create National eHealth Network, Legislate Who "Owns" Health Data

Clue - it ain't patients. Google. Microsoft. I hope someone in your healthcare organizations reads this brief. Look especially to the latter 1/3rd.

Browsing Twitter this afternoon, I learned about a House bill draft (HR ____) nicknamed "Health e-Information Technology Act of 2008" from @jesran.

It has not yet been assigned a number, but the draft copy is available here. It looks to be in pre-committee.

Sponsors: Mr. STARK (for himself, Ms. SCHWARTZ, Mr. MCDERMOTT, Mr. MCNULTY, Mr. LEVIN, Mr. EMANUEL, Mr. NEAL of Massachusetts, Mr. PASCRELL, and Mr. LEWIS of Georgia).


Why is the bill important? Take a look:

  • It defines an EHR, and places control of an EHR strictly and SOLELY in the hands of providers and staff (numbers to the left are lines in the bill), p.4:
18 ‘electronic health record’ means an electronic record
19 of health-related information on an individual that is
20 created, managed, and consulted by authorized
21 health care clinicians and staff of one or more orga
22 nizations, that conforms to standards adopted under
23 section 3003(a), and is made accessible electronically
24 to other health care organizations and other author
25 ized users."
  • On p.5, it defines providers as the following, but adds "any other category...determined appropriate by the Secretary":
2 ‘health care provider’ means a hospital, skilled nurs
3 ing facility, nursing facility, home health entity,
4 health care clinic, Federally qualified health center,
5 group practice (as defined in section 1877(h)(4) of
6 the Social Security Act), a pharmacist, a pharmacy,
7 a laboratory, a physician (as defined in section
8 1861(r)) of the Social Security Act), a practitioner
9 (as described in section 1842(b)(18)(C) of the Social
10 Security Act), a provider operated by, or under con
11 tract with, the Indian Health Service or by an In
12 dian tribe (as defined in the Indian Self-Determina
13 tion and Education Assistance Act), tribal organiza
14 tion, or urban Indian organization (as defined in
15 section 4 of the Indian Health Care Improvement
16 Act), a rural health clinic, and any other category of
17 facility or clinician determined appropriate by the
18 Secretary.

  • Pages 5-6 define HIT (line 1 denotes jump to p. 6):
23 The term ‘health information technology’ means
24 hardware, software, integrated technologies and re
25 lated licenses, intellectual property, upgrades, and
1 packaged solutions sold as services that are specifi
2 cally designed for use by health care entities for the
3 electronic creation, maintenance, or exchange of
4 health information. "

WAIT A MINUTE: HIT is "specifically designed for use by health care entities?" Are patients/consumers considered healthcare entities? I'm getting a sick feeling in the pit of my stomach here.

  • A new post is born:
"There is established within
8 the Department of Health and Human Services an Office
9 of the National Coordinator for Health Information Tech
10 nology (referred to in this section as the ‘Office’). The Of
11 fice shall be headed by a National Coordinator who shall
12 be appointed by the Secretary and shall report directly to
13 the Secretary."

  • Part of his/her job? To pave the way for a "nationwide health information technology infrastructure" that:
  1. allows for the electronic use and exchange of information
  2. ensures each patient's health info is secure under 'applicable law' (Hello HIPAA)
  3. improves quality
  4. reduces medical errors
  5. advances delivery of patient-centered medical care
  6. reduces costs resulting from inefficiency, errors, inappropriate care (say what?) duplicative care and incomplete information
  7. ensures appropriate information to help guide decisions is availble at the time and place of care (that one's a doozy - cost? quality data transparency requirements at a national level?)
  8. ensures inclusion of meaningful public input (how defined?) in development
  9. improves public health reporting
  10. facilitates research
  11. (another doozy) "promotes a more effective marketplace, greater competition, greater systems analysis, increased consumer choice, and improved outcomes in healthcare services" AKA CONSUMER CENTRIC CARE
  12. improves efforts to reduce health disparities (wait, healthCARE delivery disparities or HEALTH disparities?)

  • Every 2 years, the National Coordinator and HIT Advisory Commitee must update/make new recommendations. This is a VERY big job. Ted Eytan could take it.
  • When developing recommendations, the National Coordinator must initially refer to DOD and VA, which are cited as models of interoperability for EHRs (GAO report 08-954 p.6-8 specifically cited in the bill) p. 12.
  • The poor National Coordinator must ensure that information is collected and transmitted in "a manner that is reliable, accurate, unambiguous and (wait for it...) based on a uniform provider data set (who defines this Uniform Provider Data Set?)." The coordinator's FIRST TRIP should be to Health 2.0. Next trip to New Zealand. Third trip to Medicine 2.0.
  • Sensitive health information may be "segmented" ie broken up into little pieces and scattered into the wind to protect our privacy. Great. Good luck putting that broken picture back together, p. 14.
  • Shocker: To the "maximum extent appropriate" coordinator must incorporate CCHIT ambulatory and inpatient certification criteria.
  • National Coordinator will solicit public input via open public meetings and comment periods, p. 16.
  • She will also develop a program "(either directly or by contract)" -ummmm, SOMEONE's getting paid...-for the voluntary certification and periodic recertification of HIT systems and components.
  • The National Coordinator needs to be an open-source guru too, using definition of 'open source' as defined by the Open Source Initiative.
  • She will have to "provide for coordinating the development, routine updating, and provision of an open-source health information technology system that is either new" or based on an existing system. This system must be made "publicly available for use" 9 months after adoption of initial standards by Secretary (laughing, wiping eyes), p.17-18.
  • National Coordinator shall establish a consortium of tech, legal, clinical geeks familiar with open-source. Hello - patients? I'd give my right arm to be on this consortium. Probably literally.
  • OH MY GOODNESS. National Coordinator = Merchant of Venice. She may charge "a nominal fee" for the adoption "by a healthcare provider of the health information technology system" p. 19.
Wait a minute.

So not only are we not INCENTIVIZING doctors' use of EHRs, we're going to CHARGE THEM TO USE THE NATIONAL EHR SYSTEM?

But wait. It's all ok. If I'm a smaller provider or in a rural area I may get a price break - there is a "significant hardship exception" available to those working in areas with no Internet access (p.53). Also, hospitals may get paid a million bucks to implement (p.59), PLUS discharge volume incentives. Thanks Uncle Sam.

Also, later (p. 44-45) the bill seems to say (I could be wrong on this quick+dirty read) that IF you successfully implement and become a "meaningful user" by 2014 you get $15k. By 2015, you get 12k, 2016, 8k, 2017, 4k, and by 2018 only 2k to line your pocket.

How do they determine 'meaningful use?' Maybe by looking at drug claims submitted via the system.

Oh, and by the way, the National Coordinator has TWELVE MONTHS to develop a strategic plan detailing how to achieve the above objectives. After which case a straightjacket or lobotomy may be necessary.

The plan must also include timeframes.

The National Coordinator has to publish the strategic plan, and then subsequent implementation reports every 12 months. She can create and use task forces and work groups, in addition to the HIT Advisory Committee, for help here.

Of course, the coordinator also has to do a website, which includes grant information for HIT implementation, and appoint personnel. Staff will be funded by appropriated monies from 2009-2013.

Also, the office gains revenues from an "open source product licensing fee" (p. 26).

So, who are the National Coordinator's Knights of the Round Table? The HIT Advisory Committee. Who's on the Commitee?
  1. DHS appointees from AHRQ, CDC, CMS, HRSA, IHS.
  2. 1 member pick from Senate majority leader.
  3. 1 member pick from Senate minority leader.
  4. 1 member pick from Speaker of the House.
  5. 1 member pick from House minority leader.
  6. Presidential appointees from Veterans Affairs, NIST, and DOD. Yep. DOD!
In addition, the HIT Advisory Committee contains a very interesting dozen appointees chosen by the Comptroller General of the US. These '12 disciples' include:
  • 1 advocate for healthcare patients and consumers (!)
  • 2 healthcare provider reps (1 a doc)
  • 1 from labor union (uh oh SEIU, make sure we don't get a doc from BIDMC on here too)
  • 1 member with expertise in privacy/security
  • 1 w/experience improving health of vulnerable populations
  • 1 member from health research
  • 1 health plans/3rd party payors
  • 1 HIT vendor rep
  • 1 shall represent purchasers or employers
  • 1 w/expertise in healthcare quality measurement and reporting
  • 1 w/expertise in open source HIT systems
The HIT Advisory Committee will have 1 Chair, 1 Vice Chair, one of whom must be from public sphere, one of whom must be from private sphere. Members are paid a per diem rate and are reimbursed for travel expenses. Members serve 3 yr terms, and 10 constitute a quorum.


But adoption by "private entities" seems to be voluntary (p.34).

The National Coordinator will develop an HIT Resource Center to develop best practices, provide tech support, and accelerate the aims of the bill.

Now let's move on to carrots and sticks.

CMS and other federal agencies "relating to promoting quality and efficient healthcare in Federal government administered or other sponsored healthcare programs" may require providers to implement the system (play or we don't pay, p.40).

Medicare Advantage plans (MAs) get a variety of special incentives described with a rules schedule that's dizzying - check out pages in the 70s.

Also, there's a $115M pot of grants and loans available from 2009-2013.

Grant and loan programs may also be funded by agencies such as AHRQ available for providers and also for states and Indian tribes. Read pages in the 80s and 90s. Grant and loan recipient must demonstrate sustainability of quality improvements and cost decreases.

Medical Education Evolution folks take note - Special grants and efforts to develop academic curricula that incorporate HIT use and adoption in clinical education are proposed on page 99. Requirements are spelled out on pages 100-103. 10M bucks is available for these initiatives from 2009 -2011.

I can hear the contractors salivating now. In fact, I should start a contracting firm. It'd qualify for minority owned discounts and incentives and I'd be competing in a protected space as a female owner/exec for the duration of these funds (2009-2013). How's that for a Health 2.0 business model?

How will Joe Six Pack and Alaskan Hockey Mom learn about this initiative?

No later than a year after this bill passes (and may God have mercy on our souls), the Office for Civil Rights within DHHS will "develop and maintain a multi-faceted national education initiative" (read - poorly designed website with long, counterintiutive URL where they slap up patronizing information and quizzes) to "enhance public transparency regarding uses of their protected health information, the effects of such uses, and the rights of indivuduals."

This office will spend 10M dollars to implement this campaign. Give me 10k and I'll start a bloggers campaign that would reach more people and generate more buzz.

Big Picture Issue? Great. The government will now have access to my EHR. In fact, the government will OWN my EHR, and pay docs to keep it out of my hands.

Or so it seems at first read. On page 125, however, the bill authors tell me patronizingly that I can "obtain from such covered entity a copy of such information in an electronic format," AND that the provider can't charge me for that copy.

Well, at least they ARE saying the data can't be sold without my permission (page 125).

And on page 128 they say that providers can't use this information for marketing purposes, or to send a communication that "encourages recipients of the communication to purchase or use the product or service." In legal language, they're not considering that a qualified "health care operation."

What Happens if Your Data Gets Out?

Breaches and other privacy and security issues are covered in pages from 103-118; Google, Microsoft, and other PHR vendors will want to read p. 110 closely:

2 RECORDS.—The term ‘‘vendor of personal health
3 records’’ means an entity that offers or maintains a
4 personal health record. Such term does not include
5 an entity that is a covered entity for purposes of of
fering or maintaining such personal health record.

Big Govt. is also going to take on Google and Microsoft. Read page 131 guys. Read it again. And again.

You heard it here first: 1 year after this Act, the Secretary and the FTC will do a study on privacy+security requirements "to entities that are not considered covered entities" (see page 132, line 7, where the gauntlet is thrown, and your advertisers should you allow any, on line 8, and your partners - perhaps even patients and users, line 15). See also "business associate contracts" page 137.

And little PHR vendors, you're not out of the woods either. The government will investigate clients using your site as a cobranded app or customized PHR portal. See page 132, line 19.

Why you should read this bill draft again, and again, and again:
  1. It's a mountain of legislation that makes HIPAA look like a molehill.
  2. It also systematically reinforces the position of patient as 'other.'
  3. Consumers will not have control over personal health narratives. Our input to PHRs is trivial, 'outside' the system and relevant only for our personal use.
  4. This bill would ensure that PHRs and EHRs will forever remain disjointed halves of information necessary to improve care.
  5. It does not provide adequate time for the government to develop or acquire such a system.
  6. It does not provide adequate incentives or support for docs to implement such a system.

But, if you aren't using PHRs by 2018 anyway, I'm betting you're out of business sometime in the next 10 years.

Now, what are you going to do about it?

PS - I nominate Dr. Richard Reece for National Coordinator position. I nominate Dr. Stanley Feld to be the next Secretary of DHHS.

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