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ONC announces HITECH amendments to HIPAA privacy, security and enforcement rules

David HarlowThe federales announced a new set of HIPAA regulations today (to be published in the Federal Register on July 14) in a press conference featuring Kathleen Sebelius (HHS Secretary), Georgina Verdugo (HHS OCR Director) and David Blumenthal (ONC Director).  The HIPAA changes are essentially mandated by the HITECH Act.  From the HHS presser:

The proposed rule announced today would strengthen and expand enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Enforcement Rules by:

  • expanding individuals’ rights to access their information and to restrict certain types of disclosures of protected health information to health plans;
  • requiring business associates of HIPAA-covered entities to be under most of the same rules as the covered entities;
  • setting new limitations on the use and disclosure of protected health information for marketing and fundraising; and
  • prohibiting the sale of protected health information without patient authorization.

Two new websites were announced as well.  One is a beefed-up version of the HIPAA data breach notification wall of shame, and the other is a new HHS privacy website directed at the general public, now up at hhs.gov/healthprivacy.

This website, a joint statement from ONC and OCR posted today, and the tenor of the federales’ remarks today indicate a deep concern about public perceptions concerning privacy and security of protected health information — sort of a “what if we throw a party and nobody comes?” vibe.Continue reading…

Maybe Being Wrong is Better and More Human than Being Right

St. Augustine: “Fallor ergo sum”

When I was in charge of the medical residency programs in Grand Rapids, Michigan, David Leach introduced me to the expanded Dreyfus Model of how physicians can progress from beginners to masters.  I was always struck by how master physicians freely admitted their mistakes and used them as a teaching tool.  As a young surgical and cytopathologist, my sanity was saved more than once by University of California San Francisco’s Dr. Theodore R. Miller, a true master of cytology, being willing to share with me some of his mistakes.  I do not honestly think I could have survived in diagnostic pathology without his guidance and wisdom.  Years later, I still remember Dr. Miller showing me a breast fine needle aspiration biopsy slide of fat necrosis that mimicked ductal carcinoma and a case of wrongly diagnosed pancreatic cancer that turned out to be inflammatory atypia.

Mistakes and errors are on my mind because I just finished reading some extraordinary works.

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Why Obama Made the Right Call on Berwick

The recess appointment of Don Berwick to lead CMS can be seen as a cynical act of political opportunism, sidestepping the Congressional approval process using a tactic worthy of Machiavelli, or Karl Rove. Or it can be viewed as a pragmatic decision by Obama to avoid a lengthy and exasperating re-litigation of the healthcare reform debate.

Death Panels. Been there, done that. So I’m going with Choice #2.

The right side of the blogosphere has erupted, painting Berwick as an effete academic who would have withered under the Klieg lights and piercing questions of the likes of John Ensign and Jim Bunning. Those of us who know Don have no doubt that he would have more than held his own in debating the lessons of England’s healthcare system and the necessity of clear-headed rationing choices. Don is serious, hyper-articulate and intellectually nimble; in a real debate with members of the Senate Finance Committee, all my money would have been on him.Continue reading…

The Health 2.0 Developer Challenge–It’s On!

Today is the formal kick-off of the Health 2.0 Developer Challenge. The challenge was first announced by Federal CTO Aneesh Chopra on June 2 at the Community Health Data Initiative (CHDI) meeting, and it’s partly a continuation of the great work done within CHDI, and partly an expansion of the code-a-thon/developer camp effort to the whole Health 2.0 community. The challenge is supported by HHS. It’s being run by the Health 2.0 Conference, with partners O’Reilly, Internet2, Sunlight Labs, Healthtap & the Health 2.0 Accelerator.

Anyone can submit a challenge or join a team to solve a challenge. But the goal is to get the health care and developer communities working on building new innovative applications in rapid-fire time.

The Challenge has two parts: online and offline. The online challenge process officially begins today—there are four challenges up already and we have several others in the queue, but we’re looking for more!

  • Whyville challenges game developers to build tools for their arcade to help kids understand and apply health data. The kids will vote on the winner!
  • Move your apps; a challenge to develop an app for the Android platform that helps users burn calories, brought to you by Snaptic & Hopelab
  • Practice Fusion‘s Real Time Patient-Driven Data Challenge invites developers to build applications that connect to the Practice Fusion EMR platform.
  • The Szollosi Healthcare Innovation Program wants to see whether a lightweight EMR can be built with blog and wiki software.
  • And……Your challenge here!!

Here’s the link to the challenges page

Teams will be working on challenges over the course of the summer. Selected winners from the challenges will be showcased at the Fall Health 2.0 Conference, and we’ll be building an online community of challengers and teams in the coming weeks.

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Durenberger: Health Insurance Chickens Come Home to Roost

Former Republican Senator Dave Durenberger was always the sensible Republican on health care. He now hangs out in a small institute called the National Institute of Health Policy at a small Minnesota college called the University of St. Thomas. Every so often he puts out great commentary emails. His most recent one contains a really a great description of what happened to health insurance in the late 1990s. You can sign up here. Well worth a read and I’ve reprinted the part about insurance below—Matthew Holt

I’ve watched the ups and downs of health insurance products and “markets” since involving myself as an employer in the 70s in a community-wide effort by large employers to provide employees with a choice of health insurance plans, including the nascent HMO. Our goal was reducing health care costs through informed employees and accountable health plans, creating, in effect, new forms of insurance and competitive markets for insurance and medical services at the community level by using available information and consumer choices to facilitate behavior change.

While experiments like this across the country have been tried with varying success, we are now on the verge of doing a “back to the future” adaptation of our lessons learned. The health reform law (ACA) provides for state-based health insurance regulation, health insurance exchanges and a new emphasis in assisting “smart buys” by employees. Recall what happened to the HMO: It became large national “managed care organizations” like UnitedHealth Care (UHC) who lost community support for their behavior change because savings never stayed with those who earned them.

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Esther Dyson – “Health, Not Healthcare!”

At the Health 2.0 Goes to DC conference Esther Dyson gave a powerpacked 3 minute rant about how the Health ecosystem really works — dividing it into three markets: Healthcare, Bad Health and Health 2.0.

In a Surprise Move, Administration Appoints Berwick to Head CMS

Tuesday night the White House Blog explained: “In April, President Obama nominated Dr. Donald Berwick to serve as Administrator of the Centers for Medicare and Medicaid Services (CMS). Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points.

“But with the agency facing new responsibilities to protect seniors’ care under the Affordable Care Act, there’s no time to waste with Washington game-playing. That’s why tomorrow the President will use a recess appointment to put Dr. Berwick at the agency’s helm and provide strong leadership for the Medicare program without delay.”

A “recess appointment” means that the president is putting Berwick in place while Congress is on recess (i.e. is taking a vacation). As a result, Berwick won’t have to go through a Senate confirmation hearing. Senate conservatives had made it clear that they hoped to defer this hearing for as long as possible.

The White House Blog notes that “CMS has been without a permanent administrator since 2006, and even many Republicans have called on the Administration to move to quickly to name a permanent head.”

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Leapfrogging CPOE

Leapfrog group

Last week, yet another alarming Computerized Physician Order Entry
(CPOE) study made headlines. According to Healthcare IT News, The Leapfrog Group, a
staunch advocate of CPOE, is now “sounding
the alarm on untested CPOE”
as their new study “points
to jeopardy to patients when using health IT”.
Up until now we had
inconclusive studies pointing to increased and also decreased mortality
in one hospital or another following CPOE implementation, but never an
alarm from a non-profit group who made it its business to improve
quality in hospitals by encouraging CPOE adoption, and this time the
study involved 214 hospitals using a special CPOE evaluation tool over a
period of a year and a half.

According to the brief Leapfrog
report
, 52% of medication errors and 32.8% of potentially fatal
errors in adult hospitals did not receive appropriate warnings (42.1%
and 33.9% accordingly, for pediatrics). A similar study published in the
April edition of Health
Affairs (subscription required)
, using the same Leapfrog CPOE
evaluation tool, but only 62 hospitals, provides some more insights into
the results. The hospitals in this study are using 7 commercial vendors
and one home grown system (not identified), and most interestingly, the
CPOE vendor had very little to do with the system’s ability to provide
appropriate warnings. For basic adverse events, such as drug-to-drug or
drug-to-allergy, an average of 61% of events across all systems
generated appropriate warnings. For more complex events, such as
drug-to-diagnosis or dosing, appropriate alerts were generated less that
25% of the time. The results varied significantly amongst hospitals,
including hospitals using the same product. To understand the
implications of these studies we must first understand the Leapfrog CPOE evaluation tool,
or “flight simulator” as it is sometimes referred to.

Continue reading…

Navigating Cancer

Gena Cook is the CEO of Navigating Cancer, a new Health 2.0 company aiming at getting cancer patients online with their care providers. Gena tracked me down in a Starbucks in Seattle (oxymoron I know) when I was up there last week, and she told me about the new company. Here’s the (short) interview

Todd Park on Health 2.0’s Role in a World of Data Liberation

At the Health 2.0 June conference in DC Chief Technology Officer of the US Health & Human Services, Todd Park, participated in the panel discussion on Health 2.0’s role in a world of “Data Liberacion”. He spoke about the data libration movement and how the government has made great amounts of health data available to developers resulting in apps and tools that can provide new insights and improve healthcare.



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