Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, June 19, 2012

Patient-Generated Data - Your Input is Requested!

ONC’s federal advisory committees (FACAs) held a full-day hearing on June 8 (written testimony can be found here) to explore how patient-generated health data (PGHD) might be incorporated into Meaningful Use (MU) of EHRs for Stage 3 of the EHR Incentive Programs. Some examples of PGHD are data from a patient’s personal health record, data from a blood glucose monitor, or information about a patient’s functional status. Three FACA workgroups hosted the hearing: The Health IT Policy Committee’s MU and Quality Measurement Workgroups, and the Health IT Standards Committee’s Consumer Engagement Power Team.
The hearing built off of not only the committee’s previous MU recommendations, but also its 2010 hearing on patient and family engagement. The blog generated several dozen thoughtful comments after the 2010 hearing, and we hope that will be the case with this blog post! ONC and the FACAs look forward to additional input via this blog, which will help inform the workgroups’ and committees’ future deliberations on recommendations for Stage 3. We encourage you to voice your perspectives in the comments section below.
In particular, the hearing and discussion among committee members generated many areas and concepts of great interest upon which we would appreciate comment. We’d greatly appreciate input on the following questions:
               How can we ensure that patients’ reports of symptoms and their knowledge of their own contraindications make their way into EHRs?
               Although there clearly is a need to have a structure for PGHD, does all PGHD for care management need to be in a structured form?
               In order to manage the legal, policy, and operational issues associated with provider collection of PGHD, what should individual providers do to ensure they have a plan for managing that data?
               Patients – particularly those living with chronic conditions – have an ongoing stream of information, for which clinical encounters with the delivery system are infrequent data points. What is the relationship between that data stream and the EHR?
               Although PGHD has some specific needs, identification and sourcing of all data sources are important; how can addressing PGHD management issues help clarify how data sources are tagged more generally in the EHR?
               For which health issues is it clear that patients and families are the authoritative source?
               How should we balance the need to build in the capability for providers to incorporate structured PGHD into the EHR without being overly prescriptive?
               Similarly, how should we balance the concern about being overly prescriptive with ensuring a certain degree of interoperability, usability and understandability of PGHD?
               What important implications does PGHD have for the robustness of clinical decision support, quality measurement, and care coordination?
               How can collection of PGHD address health disparities and what cautions exist to ensure that disparities are not widened?
We look forward to hearing from you.

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The EHR/MHR belongs to the patient/citizen/human being. The patient/citizen/human being should have the ability to go into the record and make changes/corrections. The real life example is my brother’s clinical record stated that he smoked 20 packs of cigarettes daily when, in fact, he smoked one. The correction (Mayo Clinic) took nearly 3 months and could have cost him his health insurance and clearance for further revision surgery on his failed medical device implant (FDA MedWatch Adverse Event #5009052). The providers are merely “riders” on the EHR/MHR and all information that is entered into the record is no longer “proprietary”.
Moving testimony at ONÇ HIT meeting June 8, 2012

Incorporating Patient-generated Information to Manage Health
HIT Policy Committee Hearing
June 8, 2012
Testimony of Nikolai Kirienko

Project Director, Crohnology.MD
University of California, Berkeley

Thank you for the opportunity to testify before this committee. At the White House Summit on Health Care Reform, it was stated that 5% percent of patients contribute 55% to the total cost of care. In solidarity with this group, as both a young adult with a chronic care condition, and as a disabled student at UC Berkeley, I hope my testimony will speak to the urgent need to give these patients representation in their medical record that they do not have today.

We, the people providers call patients, most often navigate care by voice.  We tell our stories, in clinic, and at the bedside, in search of a cure for what ails us. Yet, we are not always heard-- especially when our illness cannot be easily seen by others-- or ourselves.

From ages twelve to eighteen, I hardly looked sick, despite years of disabling symptoms, and semesters of missed school.  I was airlifted from a ski resort with a full bowel obstruction, but on the day my intestines had finally scarred shut from the progressive inflammation of Crohn's disease, not even my family would have guessed.

Through the six months that followed at Children's Hospital Oakland, I was unable to eat, and received nutrition through a surgically placed central line.  A teenaged friend in the hospital, Anastasia, also battling colitis, had one as well.  We both developed a severe complication at the same time; a blood clot at the end of our central line.  My arm swelled up like a water balloon; my hand looked like a purple mickey mouse glove. I was the lucky one.

Anastasia's clot went undiagnosed, until the day she went under general anesthesia for emergency surgery.  Her clot broke off, traveled to her lungs and she coded on the operating table with a pulmonary embolism.  They were unable to save her.
This experience made a profound impact upon my life.  Later, in college, as I was being wheeled into an operating room in Boston for my second surgery, I noticed a trace amount of swelling in my fingers.  All scrubbed into their operation, my team of surgeons did their best to convince me that it was nothing.  

I knew that this was not how my story was supposed to go; I disagreed with their assessment.  

I revoked my consent on the operating table. And I asked for an ultrasound to locate what I believed to be another undiagnosed blood clot at the end of my central IV, called a PICC line. Reluctantly, they agreed. The ultrasound revealed a clot.

Fast forward seven years, multiple surgeries, and 5 identical blood clots later: I found myself on an operating table in need of central access, once again. This time, my care team knew this story well, and everyone was in agreement-- we would not be repeating that same procedure.

Yet, down in the OR, they began to numb the fold of my arm, prepping me for a dreaded PICC line. I froze. This was not the verbally agreed upon plan. In a panic, I recited my story. The folks in the masks were unconvinced by my invisible history.

Within 24 hours, I had a deep vein thrombosis in my right subclavian artery.  It moved to my lungs, and I had a pulmonary embolism.  

Why am I sharing this story with you today-- and what does it have to do with standards for patient generated data?
Patients are a vital source tacit knowledge, not always included in the medical record.  Yet, we have but minutes at the point of care to verbally transfer up to a decade of experience and preferences for care.  

Democracy is defined by participation, so how can it be that our health records are not?  

Patients make life and death decisions with the aid of this document. We should have a right to see it when it matters most-- when decisions are being made-- not 30 days after. Our constitutions physically and as a nation should align in the electronic health record where life, liberty and pursuit of happiness rely equally upon them both.

As an incoming student at UC Berkeley, they tell us you have all the resources to change the world.  I believed them, and with a grant from the Robert Wood Johnson Foundation, I set out to give patients a voice in their care that I never had.  

We developed an app that enables patients to record observations of daily living, allowing them to visualize their experience on an iPad, which they can share with their providers at the point of care.  It can track pain via SMS, weight from a wifi weight scale, and sleep and activity via a Fitbit activity monitor, in addition to medication adherence and lab results entered on an iPhone, among other measures, equipping a more complete view of a patient's health.  

The simple idea was to create a common frame for collaboration: to empower a patient and provider to see and discuss the same health story at the same time, when it matters most-- face to face, at the point of care.

However, in our findings from Project HealthDesign, we discovered technical barriers to collaboration in the workflow.  Patients were hand transcribing lab data from their patient portal into our app, as a means to see their data all together, in context.  Physicians were able to see trending daily weight values on their patients for the first time, instead of at the usual 3 month intervals they're used to. Yet, they still had to 'eyeball' the graph, and write a text note for the chart, losing the value of the data itself. 

What I am here to say to you today is: please make meaningful use a dynamic two way street-- a national, open API for health record data.  

Grant patients easily consumable access to their data on mobile devices, and make interaction with health data as simple for a patient as logging into Facebook or Twitter-- or their bank.  Besides unleashing an ecosystem of innovation for app developers, it can engage patients and caregivers in their health on a scale equal to the great challenges we face.  

By removing these barriers to collaboration, it will unlock the potential of mobile devices to function like the digital equivalent of the patient whiteboards hanging in virtually every hospital room across the country.

Above all, please enable patients, providers and caregivers to see the same story at the same time: it will empower them to write that happy ending that our system deprives thousands of Americans who, unlike me, are losing their lives to easily preventable medical errors every day of every year, as we speak.  

Thank you.

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