{"id":10401,"date":"2011-09-30T08:00:24","date_gmt":"2011-09-30T12:00:24","guid":{"rendered":"http:\/\/pmedicine.org\/epatients\/?p=10401"},"modified":"2011-09-29T20:05:09","modified_gmt":"2011-09-30T00:05:09","slug":"lab-results-for-all-of-data-liberation-participatory-medicine-and-government-2-0","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2011\/09\/lab-results-for-all-of-data-liberation-participatory-medicine-and-government-2-0.html","title":{"rendered":"Lab Results for All! Of Data Liberation, Participatory Medicine, and Government 2.0"},"content":{"rendered":"

On September 14, HHS released for comment draft lab results regulations<\/a> that will, if finalized, effectively bathe the Achilles’ heel of health data in the River Styx of \u00a1data liberaci\u00f3n!<\/em>\u00a0 Lab results will be made available to patients, just like all other health data.\u00a0 (See the HHS presser<\/a> and YouTube video<\/a> from the consumer health summit … “Putting the ‘I’ in Health IT.”<\/em>)<\/p>\n

Forgive me for mixing my metaphors (or whatever it is I just did), but even though there are just a couple dozen words of regulations at issue here, this is a big deal.<\/p>\n

When HIPAA established a federal right for each individual to obtain a copy of his or her health records, in paper or electronic format, there were a couple of types of records called out as specifically exempt from this general rule of data liberation, in the HIPAA Privacy Rule<\/a>, 45 CFR \u00a7 164.524(a)(1)<\/a>: psychotherapy notes, information compiled for use in an administrative or court proceeding, and lab results from what is known as a CLIA lab or a CLIA-exempt lab (including\u00a0 “reference labs,” as in your specimens get referred there by the lab that collects them, or freestanding labs that a patient may be referred to for a test; these are not the labs that are in-house at many doctors’ offices, hospitals and other health care facilities — the in-house labs are part of the “parent” provider organization and their results are part of the parents’ health records already subject to HIPAA).<\/p>\n

(“CLIA” stands for the Clinical Laboratory Improvement Amendments of 1988, which established quality standards for certain laboratory testing.)<\/p>\n

This carveout of lab results from patient-accessible records has long been a thorn in the side of the e-patient.\u00a0 This month, the federales announced that they would step forward as Androcles to the e-patient lion (to jumble a reference or two), and pull out the thorn, by proposing to amend both the CLIA regs and the HIPAA regs.\u00a0 The HIPAA regs include the exception described above: all records must be made accessible upon request except labs and a couple others.\u00a0 The lab results exception will be deleted from the HIPAA regs if the change is finalized.\u00a0 The CLIA regs prohibit lab delivery of results directly to patients.\u00a0 The proposed amendment says that the labs “may” release the results directly to patients.\u00a0 The net effect is that patients will have the right to request the results, and since labs will be permitted to release them, they will have to do so.<\/p>\n

As some readers will recall, HIPAA regs were subjected to a state-by-state “pre-emption analysis” when they came out.\u00a0 (Generally speaking, Federal law “pre-empts” state law unless state law is more protective of an individual’s rights or health.)\u00a0 The feds note:<\/p>\n

A number of States [most, actually] have laws that prohibit a laboratory from releasing a test report directly to the patient or that prohibit the release without the ordering provider’s consent. If adopted, the proposed changes to \u00a7 164.524 [of the HIPAA regs] would preempt any contrary State laws that prohibit the HIPAA-covered laboratory from directly providing access to the individual.<\/p><\/blockquote>\n

Thus, labs in most states have some work to do in figuring out how they will actually release results directly to patients once the regs are finalized and effective (which could be about a year, folks, so sit tight).<\/p>\n

Here’s where it gets fun, folks:<\/p>\n

While individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts (for example, individualized medicine and an individual’s active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.<\/p><\/blockquote>\n

CMS goes on to say that the HIT Policy Committee\u00a0 at ONC, established by the HITECH Act, says that “CLIA regulations are perceived by some stakeholders as imposing barriers to the exchange of health information.\u00a0 These stakeholders . . .\u00a0 believe that the individual’s access to his or her own records is impeded, preventing patients from a more active role in their personal health care decisions ” … so we’re going to change them.<\/em> \u00a0[Paraphrase and emphasis mine.]<\/p>\n

Let me restate this, folks: the regs are being changed to give greater patient access to health data not because of a recent change in the law, but becuase patients and patient advocates spoke up, and the HIT Policy Committee got the message.<\/em><\/p>\n

I had the opportunity to hear\u00a0Dr. Farzad Mostashari<\/a> (National Coordinator for Health IT), Lygeia Ricciardi<\/a> (Senior Policy Advisor for Consumer eHealth), and Jodi Daniel<\/a> (Director, Office of Policy & Planning) speak at an ONC town meeting at this week’s Health 2.0 conference and they are nothing if not passionate about promoting patient access to health data. (Please take a look at my mini video interviews with Dr. Mostashari<\/a> and Ms. Ricciardi<\/a>, if you need any confirmation.)<\/p>\n

This change may improve patient access to lab results, but only if the right to obtain the results is ushered in together with an education campaign that alerts patients to this new right, and if the results are presented in a manner that includes some minimal level of interpretation (and I recognize that too much interpretation will cross the line into the communication that needs to take place between the patient and his or her clinician). \u00a0On the question of how lab results should be presented to patients, at Health 2.0, Thomas Goetz, of Wired<\/em> magazine, presented a\u00a0\u00a0patient-friendly lab report\u00a0tool, to be rolled out soon by his company, 1 + 1 Labs. \u00a0Other approaches, of course, are possible, since numerous institutions already provide this data directly to patients.<\/p>\n

A certain percentage of lab results never make their way to the patient — and the patient education piece of the rollout could result in that percentage being reduced, or even eliminated.<\/p>\n

There is opposition to the proposed rule by some providers<\/a>, who express a concern that a patient who receives lab results directly may well (a) misintepret a value that is “normal” for the population at large but that might not be “normal” for her and\/or (b) fail to communicate with the clinician who ordered the test.\u00a0 In our fee-for-service world, some cynics may say that some clinicians are being inappropriately incentivized to seek another billable patient encounter for discussion of results.\u00a0 In the future of bundled, episodic, prospective payment systems, this would not be a concern.\u00a0 In fact, since we will be asking the entire health care system to be doing more with less as a result of the nation’s fiscal and political environments, frictionless sharing of information should be welcomed by providers. \u00a0Providers will continue to receive lab results, and will continue to be expected to discuss them with their patients.<\/p>\n

Comments on the draft rule are invited, and the Society for Participatory Medicine will be supporting this change.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

On September 14, HHS released for comment draft lab results regulations that will, if finalized, effectively bathe the Achilles’ heel of health data in the River Styx of \u00a1data liberaci\u00f3n!\u00a0 […]<\/p>\n","protected":false},"author":11,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[1,35,5,59,62,2],"tags":[1133,4605,58,417,1632,7709,169],"coauthors":[],"class_list":["post-10401","post","type-post","status-publish","format-standard","hentry","category-general","category-key-people","category-ptdoc-co-care","category-policy-issues","category-reforming-healthcare","category-trendsprinciples","tag-access-to-data","tag-data-liberation","tag-health-20","tag-health-data","tag-health-data-rights","tag-medical-records","tag-participatory-medicine"],"yoast_head":"\nLab Results for All! 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