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Transformations in Research
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A technician reviews a digital mammography file. |
Thousands of women face the same torturous wait every year. After enduring the discomfort and pain of having a mammogram, they can only sit by the phone until their doctor calls with the results. The wait can be agonizing as they ask the question: Am I healthy or will the physician say the dreaded word “lump?”
Until 2002, women would wait months for mammogram results while their files traveled cross-country to specialists’ offices. But a group led by the University of Pennsylvania eliminated the waiting period with the National Digital Mammography Archive (NDMA), the largest database of its kind. Together, Pennsylvania, the University of Chicago, the University of North Carolina, the University of Toronto and contractors at the Oak Ridge National Laboratory in Tennessee created a searchable medical records catalog.
The archive improves mammography procedures in several ways. Besides reducing the time required to perform a digital mammography, it produces images that are easier to read. Once the files are in the system, doctors can access the information with just a few keystrokes, paving the way for rapid diagnosis. NDMA also provides avenues for women to contribute to breast cancer research.
After two years in development, NDMA gives doctors an opportunity to collaborate on tough cases and treat patients from underserved areas. Currently, i3Archive, a healthcare images and data company, partners with IBM, GE Medical Systems, iCAD and Siemens to provide NDMA technology to hospitals. i3Archive has made the database available to hospitals nationwide but not all facilities are enrolled in the project.
The NDMA group received a three-year, $6 million grant from the National Library of Medicine’s Next Generation Internet initiative. Since 2002, the NDMA, which can recall mammography records within 2 to 90 seconds, enrolled approximately 10 patients each day. But when the partnership with physician-owned Radiology Ltd. of Tucson is completed, NDMA will gain access to more mammograms than it has collected to date, said Derek Danois, executive vice president and chief operating officer of i3Archive.
Deciding to use mammograms for a medical records archive was an obvious choice, according to the project’s supervisor at Pennsylvania. Mammograms had several built-in advantages over other tests such as MRIs or CT scans.
“Mammograms were a compelling clinical opportunity because it is the only standard imaging screening done on women, and all old information and new data are important,” said Mitchell Schnall, M.D., Ph.D., associate professor of radiology and chief of the Division of Magnetic Resonance Imaging at the University of Pennsylvania Medical Center. “Also, the standards for reporting a mammogram are already set.”
Through i3Archive, hospitals and mammography facilities join the archive through a Wallplug system that attaches to the hospital’s information technology structure, according to Bob Hollebeek, Ph.D., i3Archive’s chief technology officer and a founding NDMA member. The Wallplug allows the archive to communicate with the hospital’s system, but firewalls prevent security breaches on either side. In addition, physicians can enter the archive only through select locations.
“With a Wallplug, it’s very easy for hospitals to securely acquire or send information through the archive,” Dr. Hollebeek said. “It’s much like getting power from the wall. The Wallplug is simple, small and highly secure.”
The archive has tremendous benefits for patients, physicians and hospitals. For patients, digital mammograms are quicker, and they are less likely than film copies to be lost. In addition, women who submit their records to the archive can make themselves available for clinical trials, said Diane Hockstein, Esq., president of the Susan G. Komen Foundation Philadelphia affiliate.
“Making these women eligible for a study gives them the ability to say they participated in finding a cure for breast cancer,” she said.
As participants in the archive, women can request their mammography results be burned onto a CD, allowing them to take their files to another doctor if they want a second opinion. Hockstein said having the CD removes any anxiety some patients might have about offending their doctor if they want an additional diagnosis.
Physicians benefit from the archive by gaining almost instantaneous access to a file when they need it, as well as being able to chart a patient’s medical history through several years of digital images. Other benefits include a drop in overhead and administrative costs for maintaining film files in hospitals or physician offices, increased patient safety and a reduction in potential legal fees should files be lost or misread.
Maintaining a hospital’s infrastructure integrity was only one security issue NDMA faced. HIPAA concerns were also a top priority, and the group took every precaution to ensure compliance, Dr. Schnall said. As a first step, the archive identifies mammograms upon entry as belonging to a specific facility, immediately limiting which group of physicians can see it.
Hospitals and mammography facilities can also use additional security measures to prevent unauthorized viewing, Dr. Hollebeek said. If required, doctors must use a smart card in conjunction with a PIN number and a password. The PIN and password prevent anyone who inappropriately has a smart card from entering the archive.
Once in the archive, however, physicians do not have unlimited access to all mammography files. Instead, the smart cards are encoded with different authorization levels, and doctors cannot communicate through the archive itself. Patients can also participate in the archive’s security by asking to see a list of which physicians viewed their mammograms.
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