Patient-Generated Data - Your Input is Requested!

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Federal Advisory Committees Seeking Input on Incorporation of Patient-Generated Data for Stage 3 Meaningful Use

Monday, June 18th, 2012 | Posted by: Joshua Seidman, PhD, Director, Meaningful Use, ONC | Category: FACA, HIT Policy Committee, HIT Standards Committee

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.

Joleen Chambers says:

Your comment is awaiting moderation.

June 19, 2012 at 1:24 pm

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

www.crohnology.md

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.

Congress: Pass Medical Device Safety Bill

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Consumers Union Urges Congress to Adopt Stronger Medical Device Patient Safety June 13, 2012  (FiDA blog bold,underline added)             Washington, D.C. – Consumers Union, the policy and advocacy arm of Consumer Reports, urged House and Senate leaders today to adopt a number of provisions from the Senate’s FDA User Fee Act that would better protect patients from potentially dangerous medical devices than the version passed by the House. The House and Senate are expected to vote on a final version of the legislation before the July 4th congressional recess. Recent safety problems with defective hip implants, defibrillators, and surgical mesh have harmed tens of thousands of patients and underscored the need for stronger federal oversight of these products. “The FDA needs stronger tools to ensure medical devices don’t harm the patients they’re intended to help,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.SafePatientProject.org).  “The Senate bill does more to enhance the FDA’s ability to better monitor devices once they are on the market and to make it easier to notify patients and require stricter testing when safety problems come to light.  We urge Congress to adopt the stronger patient safety provisions in the Senate bill.” The House legislation does include a number of patient safety measures that were close to the  Senate’s version – adding devices to the post market surveillance Sentinel Initiative and setting a deadline for regulations to be finalized for unique device identifiers.  But in each case, the Senate language is stronger.  Neither the House nor the Senate bill does enough to ensure devices are safe and effective before being cleared by the FDA for the market, according to Consumers Union. Below is the letter Consumers Union sent to the leaders of the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee about the legislation: June 7th, 2012 Dear Chairman Harkin, Ranking Member Enzi, Chairman Upton, and Ranking Member Waxman: Consumers Union, the advocacy arm of Consumer Reports, thanks you for your commitment to ensuring that our national system for approving drugs and devices brings safe products to the market for patient and consumer use. As you move forward in reconciling the differences between the Senate and House versions of the reauthorization of the FDA User Fee Act, please consider our top priorities, presented below: Unique Device Identifier (Senate, Sec. 607) – Support Senate. We see implementation of this current law as soon as possible as a high priority on medical devices. While it is encouraging that both Senate and House versions address finalizing the UDI rule, we support the Senate version because it sets a deadline for implementing UDIs for high risk, life sustaining and implantable devices.  The FDA does not currently have the tools and resources to adequately track and evaluate how patients with implants and other high-risk devices are faring.  Effective post-market surveillance is dependent on having UDI in place – that includes effective use of the Sentinel Initiative, device registries, and the ability to more precisely identify problems and inform patients when problems with devices are identified. Five years ago, Congress mandated the creation of UDIs when the last user fee agreement was reauthorized — setting a timeframe for implementing this system is critical to patient safety in the future. Reclassification procedures (Senate, Sec. 601) – Support Senate. The ability to create an expedited process to more appropriately reclassify devices is a tool the FDA needs in this fast-paced market. Our specific interest is in the ability to up-classify devices that have caused serious harm to patients so that similar device applications in the future will require more scrutiny of their safety. This provision does not allow expedited reclassification without cause – it must be based on new information that the agency receives about the particular device. The process outlined in the Senate version strikes the appropriate balance between providing sufficient due process for manufacturers and input from all stakeholders AND protecting patient safety. We remain concerned that this also empowers FDA to down-classify devices more quickly. While the companies will resist down-classification of devices where they have invested resources in taking a device through premarket approval, we have seen worrisome examples of down-classification of devices that then go through the De Novo process. We look forward to working with Congress to make sure that this provision works as intended to facilitate moving improperly classified devices to an appropriate classification. The Senate requirement for an annual report will help to monitor the use of this new process. Investigational device exemption – Oppose House Sec. 701, Support Senate Sec. 606. Retaining FDA’s full range of options in approving IDEs is essential to public health in general as well as the health of the specific patients involved in device clinical trials. The Senate version gives the Secretary authority to put a hold on studies that pose unreasonable risks to their subjects. This allows a time out for re-evaluation and then allows the research sponsors to make adjustments or provide more information to address concerns and resume the study. The House version would tie the hands of the FDA, limiting FDA’s ability to reject IDE applications based on the likelihood of approval. The FDA has a specific responsibility to ensure that the clinical studies done to investigate new devices are worth the risk to the subjects involved and to ensure that the many more people who would be exposed to a device post clearance or approval are not put at risk. If the FDA realizes an investigation will not support approval, patients ought not be exposed unnecessarily to risks associated with the investigation. Timeline for Post-market surveillance studies (Senate, Sec. 603) – Support Senate. We strongly support expeditious completion of 522 studies ordered by the Secretary due to concerns about the safety of devices, typically based on reports to the FDA about patient harm. Until these ordered studies are completed, doctors continue implanting them in patients and future users of the devices are endangered. It is essential that these studies about the safety of devices be done in a timely manner.  The Senate bill requires these studies to begin not later than 15 months after being ordered. Consumers Union specifically advocated for timelines for these studies to be tied to the initial Secretary’s order and urges its inclusion in the final bill. Sentinel (Senate, Sec. 604; House, Sec. 762) – Support Senate. We strongly support adding medical devices to the Sentinel Initiative and appreciate that both the House and the Senate included devices in this important post-market surveillance tool. The House version is comparable to the Senate except that it strikes a section that requires the Secretary to include reporting data of serious adverse drug experiences and events — including those submitted by patients, health care providers, and manufacturers – in the post-market risk identification and analysis system. This House language would eliminate critical information from the agency’s post-market oversight of drugs (and devices as added in both versions of the bill) and should not be removed from current law. Condition of Approval Studies (Senate, Sec. 602) – Support Senate. The Senate bill codifies a current practice that allows the FDA to require approval for high-risk devices to be contingent on completing specified post market studies. This clarifies that the Secretary can impose civil monetary penalties on companies that fail to complete these studies and will level the playing field for companies that do comply with such requirements. Thank you for your work on this important legislation. If you have any questions about the above recommendations, please don’t hesitate to contact us. Lisa McGiffert Director, Safe Patient Project

Patient Harm: Riata ICD leads unreliable

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Agonizing Choices for Heart Patients

By CHRISTOPHER WEAVER

Michael W. Minton has a device in his chest that could save his life by helping his heart beat properly. Or not.

A retired factory worker from Joelton, Tenn., Mr. Minton is one of 79,000 U.S. patients implanted with the troubled Riata defibrillator lead from St. Jude Medical Inc. STJ -0.64% The lead, a set of insulated wires, is threaded into the heart and connected to a defibrillator that zaps the heart into normal rhythm. But in a number of cases, the devices' wires are breaking through their insulation.

Doctors say the protruding wires could be a sign of dangerous electrical problems that could cause the lead to malfunction, shocking or even killing the patient.

Mr. Minton is one of those cases, though his device is still working properly, and now he's faced with a decision: Should he have the failure-prone heart device cut out, even though the procedure carries significant risk, or wait and hope that the Riata holds up.

After seeing an X-ray image of his lead that he said looked like an appliance wire stripped of its insulation, Mr. Minton, 58 years old, decided, "I want that thing out."

A small but growing number of patients are starting to agree. At a handful of institutions, including Vanderbilt University Medical Center, Brigham and Women's Hospital and the Minneapolis Heart Institute, doctors are starting to remove even some functioning Riata leads when the devices show signs of wear. So far, Vanderbilt doctors have used X-rays to identify 29 leads with significant insulation problems, and removed one-third of them, beginning with those that are also malfunctioning.

The full scope of the problem is unknown, though by some counts, involving small groups of patients, as many as one-third of Riata's leads have protruding wires. That lack of clear information creates "much uncertainty for physicians, patients and patients' families," wrote a group of U.S. senators in a May 7 letter seeking details of St. Jude's handling of the Riata situation. St. Jude said it is responding to the letter.

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St. Jude's share price plunged 10% after public attention focused on the Riata leads a month ago. The stock fell 25 cents to $38.88 in 4 p.m. trading Friday on the New York Stock Exchange. Heart-rhythm devices, including defibrillators and leads, made up more than 50% of St. Jude's $5.6 billion in 2011 sales.

The procedure to remove leads, which can tear heart tissue or leave broken pieces of the wire inside veins, is controversial. Guidance from St. Jude, which stopped selling Riata-series leads in 2010, recommends against removing the devices before they malfunction, because the risk of complications is considered high. One study of a favored lead-removal technique, in 2010, found a 1.5% chance of major complications, which can include death.

St. Jude said in a statement that its guidelines were devised with help from an independent physician advisory panel. Physician opinions may differ, and clinical decisions in general should be made on a patient-by-patient basis, it said.

The company will release a 700-patient study in June that could offer doctors more information about the risks of leaving leads with insulation flaws in place. Each patient will be X-rayed to look for the protruding wires, a St. Jude spokeswoman said.

The Heart Rhythm Society, a medical group, hasn't advised doctors whether to remove the leads, and is awaiting further data. Its president, the Cleveland Clinic's Bruce L. Wilkoff said he has removed some leads that didn't have electrical problems.

Defibrillator leads are often bound to the walls of veins and the heart by scar tissue, an obstacle that worsens with time. To remove them, doctors slide sheaths over the wires and scrape the scar tissue away, freeing the lead. The tip of the wires can become anchored in the heart wall, and removing them can tear a hole.

At Vanderbilt, Mr. Minton's doctor, Christopher R. Ellis, said his group decided to recommend to patients the removal of all leads with frayed wires visible on X-rays, even if they work.

Dr. Ellis acknowledged that the Vanderbilt approach is aggressive, but he said the group's rate of complications appears lower than the risk of Riata problems. "I don't see anything good that can happen from leaving all these leads in," he said.

Riata was recalled in December after St. Jude's medical advisers noted a higher-than-normal rate of an insulation failure, called externalization. The leads are also prone to other types of failures, and in March a study linked the devices to 20 deaths caused by short circuits. Not all externalized leads also short circuit, but new data suggests it is a sign of the problem.

In research presented Thursday at a Heart Rhythm Society meeting in Boston, 110 patients at seven hospitals who were checked with X-rays showed a 25% rate of externalized leads. Nearly one-third of those leads also had electrical problems, said Raed Abdelhadi, a Minneapolis Heart Institue doctor who presented the finding. Vanderbilt contributed to the study.

If future studies confirm those problem rates, Dr. Abdelhadi said, "If I were a patient, I'd know what I'd want."

Doctors should await additional data, said Raymond H.M. Schaerf, a Burbank, Calif., surgeon who removes leads, but who has counseled his patients against extractions when leads are functioning properly.

"When doctors get over aggressive, patients suffer more from the extraction than the actual lead," Dr. Schaerf said.

In previous recalls, such as the 2007 recall of Medtronic Inc.'s MDT -1.02% Sprint Fidelis lead, more patients were harmed by overzealous doctors than faulty leads, he said. It is not yet clear how Riata will compare with Fidelis, he said.

Laurence Epstein, chief of cardiac arrhythmia at Brigham and Women's Hospital in Boston, said that because the true risks of Riata are unclear, he leaves the choice up to his patients. After seeing loose wires in their hearts in X-ray images, some choose the extraction, Dr. Epstein said. "People don't like that time-bomb thing," he said.

"If it is externalized, in my mind, the lead has failed," said Dr. Epstein, who like others called for more data to gauge the risk.By nature, Mr. Minton, Dr. Ellis's patient, said he was inclined to deal with his Riata problem upfront, even if the procedure brings its own risks. "I'm not the type to stand in the closet for a couple of hours because there is a tornado warning," he said.

Write to Christopher Weaver at christopher.weaver@wsj.com

A version of this article appeared May 12, 2012, on page B1 in some U.S. editions of The Wall Street Journal, with the headline: Agonizing Choices for Heart Patients.

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