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.

Friday, April 27, 2012

http://bit.ly/xN2bsb  live-streamed webinar featuring patient inclusion #HITTMIT
Patient Safety and High Performance Leadership in Health Information Technology Summit

The Patient Panel - by Regina Holliday

Generic Drugs pose harm for patients/consumers: federal public policy denies justice.

LINK HERE: article from website

Generic Drugs Proving Resistant to Damage Suits

By KATIE THOMAS

Published: March 20, 2012

           

Debbie Schork, a deli worker at a supermarket in Indiana, had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it. Her case was quietly thrown out of court last fall.

That result stands in sharp contrast to the highly publicized case of Diana Levine, a professional musician from Vermont. Her hand and forearm were amputated because of gangrene after a physician assistant at a health clinic injected her with the same drug. She sued the drug maker, Wyeth, and won $6.8 million.

The financial outcomes were radically different for one reason: Ms. Schork had received the generic version of the drug, known as promethazine, while Ms. Levine had been given the brand name, Phenergan.

“Explain the difference between the generic and the real one — it’s just a different company making the same thing,” Ms. Schork said.

Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs.

Now, what once seemed like a trivial detail — whether to take a generic or brand-name drug — has become the deciding factor in whether a patient can seek legal recourse from a drug company. The cases range from that of Ms. Schork, who wasn’t told which type of drug she had been given when she visited the hospital, to people like Camille Baruch, who developed a gastrointestinal disease after taking a generic form of the drug Accutane, as required by her health care plan.

“Your pharmacists aren’t telling you, hey, when we fill this with your generic, you are giving up all of your legal remedies,” said Michael Johnson, a lawyer who represented Gladys Mensing, one of the patients who sued generic drug companies in last year’s Supreme Court case, Pliva v. Mensing. “You have a disparate impact between one class of people and another.”

The Supreme Court ruling affects potentially millions of people: nearly 80 percent of prescriptions in the United States are filled by a generic, and most states permit pharmacists to dispense a generic in place of a brand name. More than 40 judges have dismissed cases against generic manufacturers since the Supreme Court ruled last June, including some who dismissed dozens of cases consolidated under one judge.

Public Citizen, a consumer advocacy group, has petitioned the Food and Drug Administration to give generic companies greater control over their labels, a rule change that could allow users of generic drugs to sue, but the agency said earlier this month that it needed more time to decide. “Congress can make this problem go away, and the F.D.A. could, too,” said Allison Zieve, the director of Public Citizen Litigation Group. “But we haven’t seen signs that either of them is paying much attention.” A spokeswoman for the F.D.A. declined to comment.

The Supreme Court’s ruling, which was split 5 to 4 on ideological lines, has its roots in the Hatch-Waxman Act, the 1984 law that opened the floodgates to generic drugs. That law allowed companies to skip the lengthy process required to approve new drugs if they could prove that the generic drug was equivalent to its brand-name counterpart.

With few exceptions, it also required generic manufacturers to use the same labels — the lengthy list of a drug’s uses, dosages and risks — used by the brand names.

If a problem develops, the brand-name companies are responsible for changing the label, and the generic companies must follow their lead. As a result, the court’s majority ruled, generic companies cannot be held responsible for failing to alert patients to problems with their drug. The dissent, which was written by Justice Sonia Sotomayor, argued that generic companies nevertheless have a responsibility to report problems to the F.D.A. and should be held liable for failing to warn patients.

The ruling came just two years after the Supreme Court established — in Ms. Levine’s case — that, by contrast, brand-name companies can be sued for failing to adequately warn patients.

Ms. Levine was given an injection of Phenergan in 2000 during a visit to a clinic to treat a migraine headache. Her hand and forearm turned black and eventually had to be amputated. Reports had shown that the drug can cause gangrene if it enters an artery, especially if it is placed directly into the vein rather than injected into the muscle or through a diluted intravenous drip. Although the label warned that gangrene could occur if the drug came into contact with arterial blood, Levine argued that the warning did not go far enough.

She sued Wyeth and a Vermont jury awarded her $6.8 million. Wyeth appealed and the Supreme Court sided with Ms. Levine, agreeing that the company could be held liable for failing to adequately warn about the risks of a drug.

Ms. Schork, 52, was given the generic version of Phenergan when she visited the hospital in 2007 with a stomachache and nausea related to her diagnosis of Crohn’s disease.

When a nurse injected the drug into her arm, it entered her artery, and Ms. Schork’s right hand developed gangrene. In asking that the case be dismissed, lawyers for Baxter Healthcare Corporation, which then was one of several companies that made the drug but has since sold its injectable generics to another company, argued that Ms. Schork could not conclusively prove that Baxter had made the drug she took.

The judge agreed that the question could be debated at trial but said it was irrelevant because of the Supreme Court’s ruling.

Ms. Schork filed a malpractice claim against the hospital with the Indiana Department of Insurance, and received what her lawyer described as a limited award; the amount was confidential. She said she could not continue to work at her supermarket job and is now unemployed.

Soon after Ms. Levine won her case, Ms. Schork wrote to congratulate her and to share her own story. At the bottom of the letter, Ms. Levine recalled, Ms. Schork apologized for her handwriting because she was writing with her left hand. “The fact that it had happened to her and she had this same struggle — and then to hear now that it’s getting dismissed — is just beyond me,” said Ms. Levine.

Ms. Schork said she and Ms. Levine later spoke on the telephone. “I’m glad for her,” she said, “but it didn’t help me any.”

Lawyers for generic drug companies say their clients are able to provide low-cost drugs because their primary task is replicating drugs. If the companies were expected to take responsibility for updating their labels, “we would effectively start to turn generic companies into brand companies, and of course the tremendous cost savings that American consumers have benefitted from would start to wane,” said Jay Lefkowitz, who served as the lead attorney representing generic companies before the Supreme Court.

The Supreme Court recognized that its decision must make “little sense” to plaintiffs who sue generic drug companies. However, Justice Clarence Thomas wrote for the court, “Congress and the F.D.A. retain the authority to change the law and regulations if they so desire.”

Some attorneys who follow the issue have speculated that Congress and the F.D.A. are reluctant to deal a blow to generic companies, which are responsible for providing cheap drugs to millions of American consumers, especially in an election year when health care is a hot issue.

In a statement last week, Representative Henry A. Waxman, Democrat of California, who co-wrote the Hatch-Waxman Act, said he was exploring ways to address the issue, either through legislation or a rule change.

Mr. Waxman argued in a brief opposing the generic companies in the Supreme Court case last year that Congress had never intended for generic companies to be freed of all responsibility. “Congress did not intend for consumers’ rights to be categorically eliminated simply because they purchased a generic rather than a brand-name drug,” he wrote.

Camille Baruch, 18, and her family say that is precisely what happened to her. When she was 12, Camille, of Rockville, Md., began taking the generic version of the antiacne drug Accutane and developed severe gastrointestinal pain several months later. Her diagnosis was ulcerative colitis, a type of inflammatory bowel disease, and she had to have her large intestine removed.

Six years and eight operations later, doctors have not been able to stabilize her condition. Her parents said the disease transformed their daughter from a talented basketball and softball athlete to someone who will struggle with debilitating physical challenges for the rest of her life.

Thousands of patients have sued Roche, the maker of Accutane, claiming that it caused their inflammatory bowel disease, and several have won multimillion-dollar verdicts against the company. In 2009, citing litigation costs and competition from generics, Roche removed Accutane from the market. In 2010, Camille sued the makers of the three generic versions of Accutane she took. Her lawyer, Tayjes Shah, said lawyers for the companies have told him they intend to ask for a dismissal. “I have very little optimism,” Mr. Shah said.

Camille, who was in the hospital this month recovering from another operation, said she had heard the arguments that the generic companies had made. “It makes me almost want to cry every time that I think that I took something that is nearly identical” to Accutane, yet she cannot sue, she said. “I lost everything. That is not a reason enough that these people aren’t to blame.”

Consumer Reports Poll: Consumers Support More Medical Device Oversight

LINK HERE: CU website - press release

CONSUMERS UNION NEWS RELEASE     For Immediate Release:  Tuesday, March 20, 2012

Consumer Reports Poll:  Americans Overwhelmingly Support Strong Medical Device Safety Oversight

Industry Pressure Stymies Patient Protections In Draft House and Senate Medical Device Bills

WASHINGTON, D.C. –  A new Consumer Reports poll shows overwhelming public support for strong medical device safety oversight.  The poll was released just as House and Senate Committees have issued draft legislation to reauthorize the statute governing medical devices and at a time when the FDA’s process for reviewing new implants has come under intense criticism. 

The House Energy and Commerce Health Subcommittee’s draft bill would significantly weaken device safety oversight and should be rejected by Congress, according to Consumers Union, the policy and advocacy arm of Consumer Reports.  While the Senate Health, Education, Labor and Pensions Committee’s draft bill provides some additional protections for patients once devices are on the market, it misses the opportunity to enact a clear process for preventing unsafe devices from being sold in the first place. 

“Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective,” said Lisa Swirsky, senior policy analyst for Consumers Union.  “Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight.  The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices.  Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available.”

The medical device industry has been pushing Congress to scale back oversight of implants and other devices, which it claims is necessary to promote innovation and make it easier to get new devices approved.  But according to the new Consumer Reports poll, 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation. 

The vast majority of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale.  Instead, the FDA is limited to review only whether the device is similar to one already on the market.  Ninety-one percent of the Consumer Reports poll respondents said each implant should be safety tested before being sold even when similar implants were in use, and 68 percent of those respondents thought they “definitely should” be safety tested.

Current law allows the FDA to approve a new device that is similar to an existing device even when the existing device has been recalled because of safety problems.  So far, the medical devices industry has succeeded in lobbying Congress to keep this policy in place – neither the House nor Senate discussion drafts address it.  However, 71 percent of the poll respondents said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled. 

Ninety-four percent of poll respondents indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device.  Existing law gives the FDA only limited authority to require such long-term safety monitoring.

Similarly, 95 percent of respondents said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls.  No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.

Sixty-six percent of respondents indicated a high level of concern about the safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.  Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest.  The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago. 

One additional finding of the poll was that 17 percent said they had a medical implant and 47 percent have a family member or close personal friend with one.  These findings reflect the large number of Americans using medical implants that could pose a risk of significant harm if they break, leak, stop functioning or disintegrate.  

“Our poll shows that Americans support common sense reforms that would help improve medical device oversight and keep patients safe,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.  “The vast majority of the public wants strict requirements that ensure new implants are safe and effective.”

Consumers Union’s Safe Patient Project has called on Congress to require more rigorous safety testing before medical implants and life sustaining devices are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems arise. For more details, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet.

The Consumer Reports National Research Center conducted a nationally representative telephone survey about medical implants such as artificial joints and heart stents between February 9-12, 2012.  The poll included 1,000 U.S. residents (18 and older) and was fielded by vendor ORC International.  Respondents were asked their opinions about the safety, level of concern and consumer protections related to medical implants.  The margin of error is + / - 3.0 percentage points at a 95 percent confidence level.

###

Michael McCauley

Media Director

Consumers Union

mmccauley@consumer.org

415-431-6747, ext 126 (office)

415-902-9537 (cell)

www.ConsumersUnion.org

Premier healthcare alliance supports UDI for medical devices.

LINK HERE: full article at Premier webpage

Statement on legislation to require implementation of unique device identification

By Blair Childs, senior vice president of public affairs, Premier healthcare alliance

March 15, 2012

Members of the Premier alliance applaud Senators Jeff Merkley (D-OR), Michael Bennett (D-CO), Charles Grassley (R-IA) and Herb Kohl (D-WI) for introducing legislation that would require implementation of a unique device identification (UDI) system for medical devices.

UDI is the missing link to protect patient safety. Enabling healthcare providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting. In addition to these important safety benefits, automating the now manual process of tracking of medical devices is projected to save the healthcare industry approximately $16 billion each year from greatly improved efficiencies.

Although the law requiring UDI was passed nearly five years ago with broad support from hospitals, doctors, consumer groups and patient advocates, it has been awaiting approval from the Office of Management and Budget (OMB) for more than six months. Despite urging from industry requesting that UDI be fast-tracked in the approval process, no action has been taken. While OMB delays, patients continue to face the real risks of a flawed recall or an adverse event, even though a better system exists and is ready for implementation today.

It is essential that UDI regulations move out of the OMB and into implementation immediately. Electronic tracking systems are commonplace in other industries, and have been in place since the 1970s. Today we can recall tainted dog food using standardized bar codes faster than we can medical devices, including those that are implanted in patients. It's time for healthcare to join the 21st century with a fully functioning UDI system.

About the Premier healthcare alliance, Malcolm Baldrige National Quality Award recipient
Premier is a performance improvement alliance of more than 2,500 U.S. hospitals and 81,000-plus other healthcare sites using the power of collaboration to lead the transformation to high-quality, cost-effective care. Owned by hospitals, health systems and other providers, Premier maintains the nation's most comprehensive repository of clinical, financial and outcomes information and operates a leading healthcare purchasing network. A world leader in helping deliver measurable improvements in care, Premier has worked with the Centers for Medicare & Medicaid Services and the United Kingdom's National Health Service North West to improve hospital performance. Headquartered in Charlotte, N.C., Premier also has an office in Washington. https://premierinc.com. Stay connected with Premier on Facebook, Twitter and YouTube.  CONTACT:
Alven Weil
Premier healthcare alliance
704.816.5797

'Occupy Health' Protesters at the Chamber of Commerce DC/Blue Cross

Link to 5 minute video of peaceful occupation on 11/14/11




Sadly, it has come to this . . .  healthcare is a "profit center" and an "industry" for the Chamber of Commerce.  Health care leaders do things FIRST, not necessarily ethically.

Respect must be earned.

Leadership is doing it first.  Wisdom is knowing the right thing to do. Integrity is doing the right thing. Character is doing it in the face of adversity. Grace is doing it even though the recipient appears undeserving.  
Servant-hood is doing it even if it's "below your pay grade". Generosity is doing it with no expectation of reward or acknowledgement.