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Tuesday, July 24, 2012

Post MU incubation

My friend Dr. Salber. A new initiative.
Our mission is to help young health tech companies find the resources they need:
  • Money to grow your company
  • Clinical, population, and patient feedback on your ideas
  • Advice from experts
Health Tech Hatch is an online and mobile resource for health technology entrepreneurs providing crowdfunding, clinical and usability feedback, and community for young companies developing digital solutions for the health care and wellness industries. Health Tech Hatch also serves as a resource for entrepreneurs seeking relevant populations on which to pilot-test their applications at scale, and provides other consulting services to new health technology companies.
Let a thousand flowers bloom, indeed.

Apropos of the topic. Just released:

Patient-­‐Centered Outcomes Research (pdf)

As each of us travels the path of healthy to sick, person to patient, we are faced with a series of choices. Should we have an operation or stick with the pills for our heartburn? Should we take that screening test or skip it and hope this is not the year that we develop cancer? Is it time to bring my feverish child to the doctor or can I wait another day? Each of these decisions, and all the other decisions we make over the course of a lifetime, accounts for much of our personal experience with the healthcare system. The remainder of that experience relates to living with the consequences of the decisions and choices we make. Some of us do our own research at the library or on the internet, while others count on the advice of someone they trust. No matter how we make these decisions, we all agree on one thing: we want to rely on the best possible information.

The information we need to make decisions most often comes from clinical research. Clinical research includes investigations undertaken by scientists, who decide which questions to ask, what approaches to take, how to perform the work, how to interpret the results, and then ultimately how to disseminate the findings through scientific journals or other means. The last 75 years of clinical research has been marked by phenomenal advances in knowledge about the causes of disease and their treatments. Our nation’s public and private research funding organizations have helped transform modern medicine, influence the daily healthcare of all of us, and have contributed to unprecedented health and well being of our country.

Yet while these successes are all around us, from the perspective of many patients facing health decisions, this research process often misses the mark. Sometimes the research is performed on people who are so different from us that we can’t interpret the results. It includes subjects of different ages, sex, race, and without the complexity of conditions that we have. It sometimes involves treatment in care settings not enough like ours—-sophisticated research centers rather than places more like the communities in which we live. It sometimes focuses on choices that don’t apply enough to us—expensive treatments that we have to drive hundreds of miles to receive or that we might need to pay for out of pocket ... if we have the money or time. It sometimes deals in outcomes we don’t always think are that important—whether or not our blood tests are getting better instead of whether we feel better. For a lot of us, this gap between the information we need and the information we get from research leaves us without the kind of useful information we need to make healthcare decisions. We are often left frustrated by the information we have...
PCORI is one of the many initiatives that survive, given the SCOTUS decision upholding the PPACA.
The Patient Protection and Affordable Care Act (PPACA) of 2010 created the Patient-Centered Outcomes Research Institute (PCORI) to support research that can produce the type of information people and their caregivers need when they face a healthcare decision (Appendix E). The purpose of PCORI is to provide the most reliable, relevant, and useful health-related evidence for decision- makers, especially for patients and caregivers. In 2012, the Methodology Committee and the PCORI Board approved a working definition that reflects this perspective...
May the effort bear orchards of fruit.

From my friends at Ober Kaler:


Health Law Alert Newsletter
2012: Issue 12 - Focus on HIPAA/Privacy
By: James B. Wieland and Joshua J. Freemire

A number of health care providers that attested to Meaningful Use for Stage 1 have received a letter from an Figloiozzi and Company, acting as CMS's auditor for the EHR Incentive Program (the "Program" or "Meaningful Use Program"), requesting certain records related to the attestation. CMS has not, as of this writing, made any announcement of this audit initiative or of the engagement of Figloiozzi and Company. While it is always good policy to confirm the identity and authority of any entity claiming a right to review or audit records, these letters are legitimate. Citing its statutory authority under the American Recovery and Reinvestment Act (ARRA), and without any fanfare, CMS has begun to audit the attestation materials.

The letters from Figloiozzi and Company, as the Department of Health and Human Services (HHS) Secretary's designee, request four categories of information:
  • Audited entities are asked to produce a copy of their certification from the HHS Office of the National Coordinator for Health Information Technology for the technology they used to meet Program requirements. Presumably, this documentation will be used to demonstrate that the entity "possesses" a certified Electric Health Record technology system as required under Program rules.
  • Audited entities are asked to provide documentation to support the method (observation services or all emergency department visits) they chose to report emergency department admissions. This distinction plays a large role in several of the Program requirements as it determines which patients were included in the denominators of certain meaningful use core and menu items.
  • Audited entities are asked to supply supporting documentation with regard to their completion of the attestation module responses as to core set objectives and measures. While the audit letter's request is not specific, it would appear that this request is intended to solicit information beyond that already provided to CMS as part of the attestation process. A hospital might consider, for instance, producing reports substantiating the encounters that gave rise to the calculation relied upon to successfully attest. Such reports should be deidentified.
  • Audited entities are asked to supply supporting documentation with regard to their completion of the attestation module responses as to "menu set" or voluntary, objectives and measures. Again, the information request appears to solicit a level of information beyond that provided in the attestation documents themselves...


The first National Physicians Survey was conducted in 2011 to primarily evaluate physician attitudes about the emotionally charged Health Care Reform Act of 2010 (PPACA), and how it would affect their practice, income, and patients. Although this act has been the topic of heated political debates and extensive press coverage, less attention had been paid to what doctors themselves thought of the new law. The results of last year’s survey were distributed on Capitol Hill and featured in numerous publications.

Since the 2011 survey, the issues surrounding healthcare have continued to evolve, as have the impact of other external factors on practitioners.

The objectives for the 2012 National Physicians Survey build on last year’s approach, with 10 questions inquiring about change, and investigating how that change has impacted daily activities...

Where possible, we share varied opinions among respondents to identify contrasts among the physician base as a whole. For the broader topics, we share the changes in opinion from last year’s survey to this year’s.

The National Physicians Survey is unique, providing insight by listening to the practicing clinician during this time of change in healthcare. The physician voice is the equivalent of the “man on the street” when it comes to healthcare – the bridge between the regulations, laws, and administration and the health of an individual patient.

We look forward to always continuing this dialogue with practitioners about tools and resources that physicians are using to make their practices more efficient, where they think their practice will be in the future, and who will be the partners that get them there.

Nicely done. One of the unhappy stats: nearly 3/4 of the respondents (71%) believe that the quality of care in the U.S. will decline across the next 5 years.

Love this, too: "Fax remains king, but email is sneaking into the mix...regardless of what HIPAA says."
As expected, telephone and fax led the physician-to-physician interactions. Faxing was selected by over 60%. While the fax may be all but absent from many other business environments, replaced by email, this channel securely supports hand-written notes, insurance forms and lab test results. Consider this “dinosaur” of a channel as we look at physician responses; for good reason, many physicians are treading cautiously into the digital space.

Free PDF download. A joint production of The Little Blue Book and Sharecare.



So, the draft "consent management process" debate continues at my HIE. "Opt in," opt out," who's gonna be on the hook for obtaining it and riding herd on it, yada yada yada. One of our consultants got all agitated last week during a conference call over the prospect of permitting patients to rescind HIE consent at will. Notwithstanding that everyone assumes that we have to obtain it at the outset, this consultant, seeing a potential quagmire of endless consent revisions, argued that "once you're in, you're in, period."


Well, beyond that, it turns out that "consent" for "treatment, payment, or health care operations" appears to be optional under HIPAA (though stricter state laws would override that). From HHS:
What is the difference between “consent” and “authorization” under the HIPAA Privacy Rule?

The Privacy Rule permits, but does not require, [emphasis mine] a covered entity voluntarily to obtain patient consent for uses and disclosures of protected health information for treatment, payment, and health care operations. Covered entities that do so have complete discretion to design a process that best suits their needs.
By contrast, an “authorization” is required by the Privacy Rule for uses and disclosures of protected health information not otherwise allowed by the Rule. Where the Privacy Rule requires patient authorization, voluntary consent is not sufficient to permit a use or disclosure of protected health information unless it also satisfies the requirements of a valid authorization. An authorization is a detailed document that gives covered entities permission to use protected health information for specified purposes, which are generally other than treatment, payment, or health care operations, or to disclose protected health information to a third party specified by the individual.

An authorization must specify a number of elements, including a description of the protected health information to be used and disclosed, the person authorized to make the use or disclosure, the person to whom the covered entity may make the disclosure, an expiration date, and, in some cases, the purpose for which the information may be used or disclosed. With limited exceptions, covered entities may not condition treatment or coverage on the individual providing an authorization.
Now, the salient distinction they offer up is this:
An authorization is a detailed document that gives covered entities permission to use protected health information for specified purposes, which are generally other than treatment, payment, or health care operations, or to disclose protected health information to a third party specified by the individual.
 OK. 45 CFR 164.501 (pdf)
Health care operations means any of the following activities of the covered entity to the extent that the activities are related to covered functions:

(1) Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities; population-based activities relating to improving health or reducing health care costs, protocol development, case management and care coordination, contacting of health care providers and patients with information about treatment alternatives; and related functions that do not include treatment;

(2) Reviewing the competence or qualifications of health care professionals, evaluating practitioner and provider performance, health plan performance, conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers, training of non-health care professionals, accreditation, certification, licensing, or credentialing activities;

(3) Underwriting, premium rating, and other activities relating to the creation, renewal or replacement of a contract of health insurance or health benefits, and ceding, securing, or placing a contract for reinsurance of risk relating to claims for health care (including stop-loss insurance and excess of loss insurance), provided that the requirements of §164.514(g) are met, if applicable;

(4) Conducting or arranging for medical review, legal services, and auditing functions, including fraud and abuse detection and compliance programs;

(5) Business planning and development, such as conducting cost-management and planning-related analyses related to managing and operating the entity, including formulary development and administration, development or improvement of methods of payment or coverage policies; and

(6) Business management and general administrative activities of the entity, including, but not limited to:

(i) Management activities relating to implementation of and compliance with the requirements of this subchapter;

(ii) Customer service, including the provision of data analyses for policy holders, plan sponsors, or other customers, provided that protected health information is not disclosed to such policy holder, plan sponsor, or customer.

(iii) Resolution of internal grievances;

(iv) The sale, transfer, merger, or consolidation of all or part of the covered entity with another covered entity, or an entity that following such activity will become a covered entity and due diligence related to such activity; and

(v) Consistent with the applicable requirements of §164.514, creating de-identified health information or a limited data set, and fundraising for the benefit of the covered entity.
 Not a whole lot left, in practical terms. You could drive a fleet of trucks through that opening. Though, in fairness, there are issues such as "Marketing," (pdf) "psychotherapy notes," "substance abuse," and the like.

So, "consent" is largely optional, "authorization" is required in some circumstances, and is revocable at will (whereas "consent," once given, is not as a matter of federal law and regulation).

And, all of which defer to more stringent state laws.

Got it?



Gotta say, I love the convenience of e-books, though, it's too easy to make impulse download purchases and buy more than you can keep up with.

Shot that with my iPhone.

Speaking of the iPhone: July 26, 2012 update

So, one of my coworkers today told me that there's a free Dragon app for the iPhone. Well. there indeed is. How did I miss that? Here I am dictating my blog post update into my iPhone, which I'm then going to send via e-mail and then screen scrape it off and copy and put it right into the blog. Pretty neat. I didn't realize that. Cool.

Sent from my iPhone

[P]rofessionals who had signed an agreement to receive technical assistance from a Regional Extension Center were more than twice as likely to have been awarded an incentive payment (pg 6).

Elsewhere, in an otherwise negative-spin article posted on EHR Intelligence:
RECs are a game-changer: Those professionals working with Regional Extension Centers (RECs) (18.7%, 12,155) were more than two times more likely than those who didn’t 44,430 (8.3%, 44,430).
MORE iPhone: a $1.99 ECG App

From The Health Care Blog:
How the iPhone Might Disrupt The Medical Device Industry
 Doctors wanting to determine a patient’s atrial fibrillation burden have a myriad of technologies at their disposal: 24-hour Holter monitors, 30-day event monitors that are triggered by an abnormal heart rhythm or by the patient themselves, a 7-14 day patch monitor that records every heart beat and is later processed offline to quanitate the arrhythmia, or perhaps an surgically-implanted event recorder that automatically stores extremes of heart rate or the surface ECG when symptoms are felt by the patient. The cost of these devices ranges from the hundreds to thousands of dollars to use.
Today in my clinic, a patient brought me her atrial fibrillation burden history on her iPhone and it cost her less than a $10 co-pay.  For $1.99 US, she downloaded the iPhone app Cardiograph to her iPhone.
Every time she feels a symptom, she places her index finder over the camera on the phone, waits a bit, and records a make-believe rhythm strip representing each heart rhythm. With it, comes the date and time...
Interesting. Read on.


Dr. Blumenthal was ONC head from 2009 through 2011.
"We are extremely fortunate to have Dr. Blumenthal take the helm of the Fund at a crucial time in the drive to achieve a high performance health system," said Commonwealth Fund board chairman James R. Tallon, Jr. "If the U.S. is to realize the triple aims of better health, better care, and lower cost, it will need over the next 10 years unstinting efforts by health policy and practice leaders like Dr. Blumenthal. He is ideally suited to carry forward The Commonwealth Fund’s significant role in advancing delivery and payment system changes that will improve system performance."

I finally succumbed, went over to The Dark Side: Twitter.

OK. And, your strategy for making this happen is precisely ______________?

Relatedly, what are the latest developments over at ARCH-IT?

More to come...


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