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).

IF YOU ARE IN HEALTHCARE, THIS BILL IS THE MOST IMPORTANT THING YOU MAY READ THIS YEAR.

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:
  

‘‘(1) ELECTRONIC HEALTH RECORD.—The term
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":

HEALTH CARE PROVIDER.—The term
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):

‘‘(4) HEALTH INFORMATION TECHNOLOGY.—
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.

STANDARDS SHOULD BE ADOPTED NO LATER THAN SEPTEMBER 30, 2011 (p. 33).

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:

• VENDOR OF PERSONAL HEALTH (p. 110)

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
6 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.

Remember the Search Engine Wars? Get Ready for the Health App Wars

Microsoft has been quietly scouting and scooping Google on establishing "strategic collaborations" with Health 2.0 firms including American Well.

They're also stepping up the competition surrounding opensource/openid signons and sharing APIs (within set strategic parameters of course - this is still MS World we're talking about).

Who has the better health product? Debatable. At this point, probably inconsequential.

Both Google and Microsoft's slide into the consumer-centric PHR space are helping advance the market in general, as Keith Schorsch points out over at The Health Care Blog.

What matters right now is which company is able to establish a cutting-edge, market-share takeover.

My personal opinion? Neither utility is consumer-friendly enough to reach 'killer app' adoption rates of 30-40%.

Why? I've played with both tools and won't use either one, and I'm definitely the type of hyperinvolved e-patient these firms want to be wooing.

I agree with Keith that the firms are still getting it wrong:

"PHRs and electronic medical records remain an industry-driven vision, not a consumer-driven one — focused on efficiency and reducing costs. It seems we’ve lost sight of whether the consumer really desires and is willing to participate in these services."

I most definitely desire and am willing to participate in these services, when I find one that's functionally useful, stores information in an easy-to-share format, and is above all else, user friendly.

Current offerings don't come anywhere close on ANY of these points.

Unfortunately for consumers, the Health 2.0 PHR domination wars are currently all about quantity, not quality.

Right now it looks like Microsoft is winning. But looks can be deceiving.

And it remains to be seen if this early leading edge will allow Big Evil to stay ahead of the competition, especially if a new killer app enters the market and consumers adopt it quickly en-masse.

A scrub of press releases reveals multiple Microsoft partnerships in the past month (I'll do some digging and see if I can't figure out a TechCrunch-style list later today).

Now, Google could have inked just as many agreements, but may not be releasing info on them yet.

Let the Health App Wars begin...

Reasons to Celebrate - Personal and Professional

1. The Personal: After 3 days of slow labor, my sister is, even at this moment, working to bring my baby niece into the air-breathing sector. After hours in the Birth Center waiting room at Carilion New River Valley Center, we're all a bit loopy, but this is the first baby of our generation, so forgive the emotional mushiness. Hurry up, Ellen! We're waiting. Mom will tell you I'm not the patient type...

2. The Professional: At AHIP last night - the biggest Health 2.0 move to date. American Well partners with Microsoft (in a "strategic collaboration") and takes on the entire state of Hawaii. Congrats to all involved for carrying us closer to consumer-centric care. The challenges are huge, but I can't think of another team that could tackle the task with such confidence, panache, and an actual chance at success.

Medical Data and Privacy: Make it All Public?

Docs - are you more concerned about patients developing their own EMR/PHRs via Google or Microsoft, or about pharma reps surfing your insurance claims for DEA drug ID data to discern your Rx patterns?

Consumers - same question...

The privacy arguments about Google Health's trial are the same old issue, different product.

Like I said, give me a program that's already accessible by various constituents (hospitals, patients, physicians), like MSWord, and a thumb drive that I can pull out of my laptop and carry on my keychain, and voila. Why haven't I already done this? It's a pain in the hindparts, and I'd have to encode the data somehow in case I lost my keys.

I would far rather use a program developed for me, the lazy consumer, than create one on my own. If I could sign up for an independent trial (not linked to a provider/facility) with Google, would I do it? In a hot minute.

I'd even be willing to pay Google for it, say, 10 or 20 bucks a month, which allows them to increase revenues over and above their uber-successful ad driven model. AND I'd agree to watch 1-3 targeted ads that pop up right after my login page.

In fact, one way to subvert concerns about the release of private health data would be to put it all up here, on my blog. My complete medical history. The question is, am I (or any other blogger for that matter) brave enough to do that without the protection Google's program affords?

Changes the face of the debate a bit, doesn't it? Now simple password protection seems like a whole lot of safety...