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Health Management Technology News
  March 3, 2014
In this issue:
 

► Republicans blast FDA for secretly monitoring whistleblowers

► Congress seeking to limit FDA oversight of low-risk software

► HIMSS Analytics announces first Certified Educator of the EMR Adoption Model

► 'World-class' medical imaging centre set to be built in Glasgow

► ScImage introduced a universal MPI translator for PICOM365 at HIMSS 2014


Republicans blast FDA for secretly monitoring whistleblowers

Republican lawmakers blasted the Food and Drug Administration for secretly monitoring the emails of agency scientists who went public with allegations that they were pressured to approve certain medical devices.

In a report published in conjunction with a congressional hearing, two Republicans said that the FDA’s computer surveillance may have overstepped federal laws designed to protect government whistleblowers. Using software that took rapid-fire screen shots of employees’ desktops, the FDA swept up emails from several whistleblowers to members of Congress and their private attorneys. Such communications are protected from disclosure by federal law.

The report is the product of a two-year investigation by Rep. Darrell Issa, R-Calif., and Sen. Chuck Grassley, R-Iowa. Issa acknowledged in his opening statement that federal workers have no right to privacy when using government computers or property.

“But that is not to say that targeting is appropriate. That is not to say that these five scientists’ concerns are unreasonable — they are.” Issa said.

House Democrats defended the surveillance, in part, pointing to the findings of the inspector general that oversees the FDA. In a report released just ahead of the hearing, the inspector general concludes that the surveillance had a “reasonable basis” because the employees were leaking confidential information to the press about devices under review. The report also concluded that the surveillance was not targeted to capture communications with Congress or any other specific parties.

While finding justification for the monitoring, the report also faults the agency for having no system to ensure that “their investigations were conducted in accordance with laws and regulations.” As a result, the program “had significant negative consequences for FDA.”

The report does not make a final judgment on whether the FDA monitoring was lawful, noting that that question is the subject of litigation. Several of the whistleblowers have a lawsuit pending against the FDA, alleging that their right to privacy was violated.

The FDA’s chief operating officer, Walter Harris, told lawmakers that the agency recently put in place guidelines for monitoring employees’ computers.

In testimony before the House Committee on Oversight and Government Reform, Harris said policies issued last September are designed to ensure that “monitoring is utilized for appropriate purposes and takes place for no longer than necessary.”

Not present at the hearing were the FDA whistleblowers themselves, several of whom have since left the agency.

Read the full Washington Times article here ► 

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Congress seeking to limit FDA oversight of low-risk software

The drumbeat to limit FDA's regulatory authority over various software systems is growing.

Many interested parties are worried that FDA will act to regulate Electronic Medical Records (EMRs) and Electronic Health Records (EHRs) with the same rigor that is applied to the software running a radiation therapy machine.

Boston Globe reporter Tracy Jan spoke with Dan Haley, vice president for government and regulatory affairs of Athenahealth (Watertown, MA), a health information firm. “Right now, the FDA has the authority to regulate all of health IT,” Haley said. “They say they exercise discretion to pick and choose which technologies they regulate. From our perspective, that is just not a tenable state of affairs.”

In her article, Jan continues, “Backers of FDA regulation say digital records systems sometime contribute to prescribing errors and other patient mix-ups that can have dangerous, even fatal, consequences. Bad or missing data in a patient’s computer record, for instance, can lead to catastrophic medication errors.

“But the healthcare industry, including many top hospitals as well as manufacturers of the systems that manage digital records, want looser regulation. They contend that submitting to FDA safety reviews would slow the pace of innovation and make software upgrades difficult.”

Read the full report here ► 

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HIMSS Analytics announces first Certified Educator of the EMR Adoption Model

HIMSS Analytics announced that Allscripts is the first Certified Educator of the Electronic Medical Record Adoption Modelsm (EMRAM).

EMRAM is an eight-step process that allows healthcare provider organizations to analyze their level of EMR adoption, chart accomplishments, and benchmark progress against other healthcare organizations across the country. Each of the stages is measured by cumulative capabilities and all capabilities within each stage must be reached before progressing.

“As the Meaningful Use timeline tightens it becomes increasingly important for providers to align IT initiatives with overall business strategy,” said Blain Newton, Sr. VP and COO, HIMSS Analytics. “The EMR Adoption Model provides a roadmap to help organizations shape their future IT strategy.”

Read the full press release here ► 

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'World-class' medical imaging centre set to be built in Glasgow

A high-tech new imaging centre that could help with the development of personalized medicines is being funded by the Scottish Government.

Health Secretary Alex Neil announced £3mfor the initiative, which will be part of a £15.3m Glasgow University clinical research facility on the new South Glasgow Hospital site.

The funding should mean that a state of the art research imaging suite is in place when the new hospital opens in 2015.

Personalized medicine involves the creation of treatments that have been specially tailored for the patients, based on their genetic make-up. Advanced equipment at the imaging centre should help medics predict which treatments will be most efficient and effective for patients.

Mr. Neil said: "Personalized medicine holds huge potential in the development of new treatments for diseases such as cancer.

"It is one of the most significant advances in 21st century health research as it looks to move away from the one-treatment-fits-all approach to one where a patient's specific genetic makeup determines the most appropriate treatment."

Read the full STV article here ► 

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ScImage introduced a universal MPI translator for PICOM365 at HIMSS 2014

ScImage announced the availability of a new Master Patient Index (MPI) Translator that enables healthcare providers to deliver quality care to patients based on important diagnostic imaging data residing in disparate systems, often located at unrelated facilities.

Traditionally, an MPI strategy to transport images between subscribers in a cooperative environment utilizes a known MPI reference. However, strategic discussions between competing parties usually end up with no real solution. Complications develop when dealing with independent and sometimes competing institutions or multi-specialty groups. This requires an independent and intelligent translator that can provide fast and automated image transfer across multiple environments.

PICOM365 corrects this problem by using an end-to-end image transfer with an adaptive translator. The MPI translator provides a foundation for true interoperability, offering seamless image sharing and collaboration. This intelligent engine pulls and pushes images across multiple facilities and manages a seamless productive clinical workflow with comprehensive reading packages.

Read the full press release here ► 

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