Jun 18, 2007 | Laboratory Management and Operations, Laboratory News
According to a study entitled Critical Needs of Today’s Healthcare System, many healthcare institutions are within two years of purchasing wireless networking. Healthcare Informatics Magazine did a follow-up study, polling 200 of the original 300 healthcare executives and upper-level management surveyed in January 2007 for an article entitled No Strings Attached.
Healthcare Informatics’ study determined that the current state of affairs was mixed. For example, only 5% of the organizations of the 200 healthcare executives and upper-level management they polled said their organization was completely wirelessly-enabled. Significantly, three-quarters, 72%, reported a mix of hardwired and wireless networks. That left nearly one-quarter, 23%, with no wireless network. After reviewing current and existing spending plans on implementation of wireless systems, Healthcare Informatics concluded that hospitals and health systems are implementing wireless technology in a methodical progression.
The devices most often used to access wireless networks were stationary desktop PCs and workstations, followed by laptops on carts, tablet PCs, and PDAs. 69% of respondents said that PDAs were a part of their wireless network, but that multiple brands and types of devices co-existed within the enterprise. These pocket-friendly devices are being used primarily to support patients’ treatments and for ordering and access to diagnostic tests.
The paced but steady progression of wireless technology into the healthcare scene will obviously effect how laboratories deliver laboratory test data to different sectors of the healthcare system. Some hospital laboratories are already capable of capturing lab test orders transmitted wirelessly and transmitting results back via wireless. Even in the outreach environment, physician use of wireless technology has resulted in situations where the laboratory provider has collaborated to support wireless transmission of lab test orders and laboratory test results.
Wireless connectivity, by its nature, allows people to communicate on a round-the-clock basis. Just as Web connectivity enables 24/7 access to information, wireless connectivity encourages transactions on a 24/7 basis. Progressive laboratories have already recognized that the ability to communicate with selected clients using wireless technology can be a way to differentiate themselves from competitors. Strategically, laboratories would be well-advised to identify several clients already using wireless systems and cooperate with these sites to support wireless transmission of lab test orders and laboratory test results. As the use of wireless systems becomes more common in healthcare, eventually every laboratory will need to support such wireless arrangements.
Related Resources:
Critical Needs of Today’s Healthcare System
No Strings Attached by Healthcare Informatics Magazine
Jun 15, 2007 | Compliance, Legal, and Malpractice, Laboratory News
To hasten the day when all Americans have an electronic health record (EHR), last year, on August 8, 2006, the U.S. Department of Health and Human Services (“HHS”) issued regulations that would allow hospitals to provide certain software and technical support services to physicians without violating federal antikickback law. Because many physicians have been slow to invest in electronic health record systems, this new regulation is designed to encourage hospitals and health systems to step into the gap and offer software and services that support EHR systems.
This is a significant development for hospital-based laboratories. It creates new opportunities to build relationships with referring physicians. But it also creates new compliance exposure for laboratories which fail operate within the parameters of the law.
Recently the IRS weighed in on issue to provide further clarification. Titled “Hospitals Providing Financial Assistance to Staff Physicians Involving Electronic Health Records”, the IRS memo spells out the circumstances necessary to meet the safe harbor requirements of the HHS policy on the provision of software and technical support services by a hospital to physicians on staff.
Since the IRS lingo is complicated, to say the least, we asked Jane Pine Wood, attorney for McDonald Hopkins and a specialist in clinical laboratory and anatomic pathology legal matters, how this change would affect hospital laboratories. Wood responded, saying:
“The IRS memorandum offers greater assurance to tax-exempt hospitals that they can provide EHRs to members of their medical staffs, in compliance with the applicable Stark exception and the applicable safe harbor under the Medicare and Medicaid anti-kickback law, without jeopardizing their tax-exempt status. It is important to note that this memorandum provides approval only to those arrangements which comply fully with the numerous criteria of the Stark exception and anti-kickback law safe harbor.”
We also asked Wood if hospital laboratories should take any special steps to react to this memo. “For many laboratory clients, particularly gastroenterology and endoscopy providers, EHRs are increasingly important,” said Wood. “So,this IRS memorandum is of significant benefit to those tax-exempt hospitals who wish to make EHRs more accessible for their clients.”
And there you have it. Hospital laboratories that want to take advantage of the memo should carefully study the Stark exception and the applicable safe harbor under Medicare and Medicaid anti-kickback law to ensure full compliance. Once this due diligence is complete, hospital laboratories can safely make EHRs more accessible to their medical staff.
Related Articles:
Hospitals Providing Financial Assistance to Staff Physicians Involving Electronic Health Records
Jun 13, 2007 | Laboratory News
At this stage in the digital revolution, most of us are familiar with peer-to-peer file sharing networks. The most famous for its rise and fall was Napster, originally designed to enable digital music files to be transferred from one user to another. Many of these file sharing networks, such as Kazaa and Gnutella, still exist. What many people do not realize is that peer-to-peer networks can be used for sharing more than just MP3 music files. People can share any type of file, be it an image, Word document, PDF, etc, and therein lays the potential threat for the data networks of laboratories and pathology groups.
Many small companies have prohibited the installation of any new software on their employees’ computers in an effort to prohibit the installation of peer-to-peer software. This becomes somewhat more difficult as companies grow past small and become medium to large in size. In a company with hundreds or thousands of employees the IT department staff is often outnumbered by other employees and many of these employees need simple programs, downloadable online, such as Acrobat Reader and Shockwave, to view files. Often, companies let employees use their judgment in downloading programs.
This mistake can open vulnerabilities in the data networks of companies for a number of reasons. The threat is related to a new term entering the informatics lexicon, which is “digital wind.” Digital wind describes the phenomenon of how a shared file, whether shared intentionally or not, can quickly spread from one person’s computer to hundreds of others.
In a recent study on the phenomenon of “digital wind” conducted by Eric Johnson, a professor at Dartmouth College’s Tuck School of Business, Johnson noted that everything from loan applications and bank statements to tax returns can be accessed and shared on peer-to-peer networks. Many of these documents contain sensitive information, including Social Security numbers and credit card information. Those files end up in peer-to-peer networks because network users do not know how to properly set the parameters for which files on their computer can be shared and which cannot. Consequently, everything becomes shared.
Johnson found that, once a file is shared and picked up by the file sharing network, it disseminates quickly, often to people that aren’t even looking for it. Johnson cited an example in which a searcher was looking for Madonna’s performance in Wachovia Center, but found numerous bank statements and other documents from Wachovia Bank. Given improper access to computers in a laboratory, searchers might find lab test results or patient demographic and financial information, in addition to other proprietary and confidential documents.
Companies that lose proprietary information via peer-to-peer networks have little legal recourse to reclaim the information. They can punish the employee, but the damage cannot be undone.
Another vulnerability companies have when they allow peer-to-peer file sharing networks on company computers is exposure to lawsuits. If an employee has hundreds or thousands of illegal music files on his or her company computer, the company can be sued for the illegal storage of copyrighted files. In some cases, large awards in resulting lawsuits can financially damage or force small to medium-sized companies to declare bankruptcy.
The moral of the story for laboratories and other healthcare providers is to protect your company computers. Recognize the vulnerability that peer-to-peer file sharing software creates. Do not give employees, no matter how Web-savvy they are, the right to install software on their computers. It can open holes in the security of the data network and lead to stolen information. Because of the huge amounts of sensitive data about patients in laboratory information systems, this is a real threat and steps should be taken to close this window of vulnerability.
Related Articles:
Sharing MP3s may mean sharing far more
Risky Business: What Must Employers Do to Shield Against Liability for Employee Wrongdoings in the Internet Age?
Jun 12, 2007 | Laboratory Management and Operations, Laboratory News, Laboratory Operations
Dark Daily recently caught up with Michael J. Becich, M.D., Ph.D. from the University of Pittsburgh School of Medicine. He is the Course Director of the upcoming APIII conference on anatomic pathology informatics and imaging support for translational medicine and an international expert on the digitization of anatomic pathology.
We queried Dr. Becich about his views on the three most important new developments in pathology informatics. Because he is on cutting edge of new technologies and applications, his insights can cue pathologists about what is likely to change in the way anatomic pathology groups capture information and report it to referring clinicians.
Number one on Becich’s list is the continued deployment of synoptic reporting. Synoptic reports are structured, textual reports with coding and standards built in. Laboratory Information System (LIS) vendors continue to push this feature and it is enabling laboratorians to data mine from pathology reports. This development is important because, “For years, pathologists dictated reports as large blocks of text and valuable information was locked inside those reports,” observed Becich. “Now, with synoptic reports, that valuable information is directly accessible.”
Next on Becich’s major list of trends is the continuing development of whole slide digital imaging. Radiology has been converting to digital picture archiving systems (or PACS) for some time. Now, pathology is moving down the same road, with glass slides being converted to digital files. This development is important because “pathologists frequently must transport slides around to numerous locations and it is often difficult to share a glass slide with others. Digital slides provide a cost-effective way to easily and instantaneously share slides and improve patient safety,” said Becich. He also pointed out that digital slides offer the opportunity for pathologists to work from a totally-digital and analytical desktop. One major benefit is that it makes it easier for pathologists to more widely distribute information to patients and stakeholders who want it.
The third development on Becich’s radar screen is quantitative image analysis. Pathologists now have computer algorithms that assist them in the interpretation of images. This is particularly important for immunohistochemistry. Billing codes are now available that pathologists can bill for (if they choose to) use these computer-assisted devices. “This trend is important, said Becich, “These computer algorithms enable a pathologist’s digital desktop to provide high-volume, high-throughput quantitative analysis. In the era of personalized medicine, the qualitative evaluation (1+, 2+, 3+ method) is not sufficient for the interpretation of immunohistochemistry.”
Laboratorians interested in learning more about these trends should attend the APIII conference. It will take place on September 9-12, 2007 in Pittsburgh, Pennsylvania at the Marriott City Center Hotel.
Jun 8, 2007 | Compliance, Legal, and Malpractice, Laboratory News
Earlier this week, Digene Corporation (Nasdaq: DIGE) announced that it would be acquired by Dutch firm Qiagen (Nasdaq: QEN) for a purchase price of approximately $1.6 billion. Digene has been involved in patent infringement lawsuits during the past year in efforts to protect its HPV patents.
It was announced on Monday, June 4, that Digene will be purchased by Qiagen, a Dutch maker of tools for gene research. This gives Quiagen access to Digene’s patented HPV test, and tests for sexually transmitted diseases. Digene’s HPV test is the only one that has been approved in the U.S. and Europe. The purchase gives Qiagen “instantaneous market and technology leadership” in molecular diagnostics and will be “a catalyst for growth,” Peer M. Schatz, CEO of Qiagen, said.
It was announced back in January that Digene was suing Third Wave Technologies (Nasdaq: TWTI) over alleged patent infringement. The suit alleged that Third Wave infringed on a biotechnology patent involving human detection of the human papilloma virus (HPV).
Third Wave countersued Digene in early March by filing an anti-trust suit that alleged that Digene “abused its monopoly power to thwart competition” in the HPV diagnostic market. The current legal action is interesting because Digene and Third Wave had earlier entered into an agreement to dismiss, without prejudice, a declaratory judgment action filed by Third Wave against Digene for the same HPV detection technology. It was January 2006 when both parties agreed to throw out that lawsuit.
Digene has also been pursuing legal action against Ventana Medical Systems (Nasdaq: VMSI) in another patent infringement lawsuit. Last month the U.S. District Court for the State of Deleware denied Digene’s motion for a preliminary injunction against Ventana. “Although we are disappointed with the court’s ruling, the denial of our preliminary injunction request was not unexpected given the pending expiration of the patents at issue in May and June,” said Daryl Faulner, President and CEO of Digene. In the ruling, the court noted that there remains a substantial question as to whether Ventana has a license to the relevant HPV patents.
Digene’s acquisition by a larger in vitro diagnostics (IVD) manufacturer is another example of the ongoing consolidation in the IVD industry. Along with the strong price Qaigen is paying, it demonstrates the high interest investors have in molecular diagnostics. Interestingly, during May, another major IVD company in cervical cancer screening was acquired. Cytyc Corporation (Nasdaq: CYTC) is being sold to Hologic (Nasdaq: HOLX) in a deal valued at $6.2 billion and expected to close during the third quarter.
Should acquisitions continue in the IVD industry at the current pace, it will certainly change the competitive landscape. Further, much of the molecular technology currently finding its way into new clinical assays has been developed by start-up companies. For that reason alone, the established IVD giants will need to scramble to develop or acquire comparable molecular technology that will help them maintain market share.
Related Articles:
Digene sues Third Wave over patent
(last article at the bottom of the page)
Digene Files Infringement Suit Against Third Wave Technologies
Third Wave files countersuit vs. Digene in patent case
Preliminary Injunction Denied in Digene’s Case Against Ventana Medical Systems
Qiagen to Buy Digene, Maker of Tests for Cancer-Causing Virus
