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EUROPEANS READY FOR PRIVACY LAW

June 1, 1998
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EUROPEANS READY FOR PRIVACY LAW

A major European Union privacy law goes into effect this October, setting a global standard for tough protection of private information. The EU Data Protection Directive was passed in 1995 to establish a common set of data protection laws governing the access, use and storage of personal data in EU nations. Every EU country must have national laws in place by the fall. A few countries such as Italy and Greece have already enacted laws. Others, such as the U.K., France and Germany, have bills under debate now. "It will considerably strengthen the data protection environment we have in Europe," notes Barry Barber, a consultant with British firm Health Data Protection, Ltd. Barber says the result should be a more uniform policy for data protection from country to country.

The directive establishes detailed rules for the secure processing of personal information. It will require informed consent for release of data to a third party, provides citizens with a host of rights including access to their data and a record of which parties are using it and why, denotes special protection for "sensitive" data which would include medical records, and largely prohibits the export of data outside the EU to countries that do not have comparable privacy standards. In particular, parties in the United States will not be able to receive or process EU personal data without a special contract.

Software providers marketing in Europe will have to make sure their systems incorporate adequate access, tracking and authorization controls. Yet according to Philip Jones, an assistant registrar with the Data Protection Registrar, an independent office in southern England that reports to the British Parliament, software modifications should not be a burden. "I don’t think there’s anything in the bill that would require people to have massive restructuring of their systems."

The U.K. is one of several EU nations that have had legislation for data protection in place for years. The Data Protection Act of 1984 already complies with roughly 80 percent of the directive, according to the Data Protection Registrar. The most significant changes of the directive, says Jones, are the inclusion of manual records (the 1984 Act applied specifically to computerized data), a more stringent registration system for recording transactions of personal information, and the export rules. Jones says it is too early to make any accurate cost estimates of compliance with the new law.

"I personally think that one of the most important things will be the third-party disclosure registrar because healthcare is now being provided by a variety of different organizations and agencies rather than one central one," Barber says. Data controllers at every European organization will have to report details on the use of personal data to a national data protection registrar.

The NHS and the British Medical Association are currently debating how and if to use strong encryption for medical records, according to Barber. He believes it will take a good five to 10 years before a security infrastructure is in place that allows the widespread use of smart cards, encryption and other security tools. Still, Europe has made substantial progress in gaining acceptance for security standards, such as the EU standards body CEN’s 12924 standard for healthcare information systems.

The vital exchange of data between Europe and the U.S. will be hampered greatly--affecting multinationals and the financial community particularly hard. Pharmaceutical and medical device manufacturers may also face difficulty in using patient data from Europe in clinical trials, research databases or marketing purposes--even with certain exemptions in the directive for scientific research and preventive medicine, according to Peter Swire, an associate professor at The Ohio State University College of Law who is co-author of a just-released book on the subject: "None of Your Business: World Data Flows, Electronic Commerce and the European Privacy Directive."

While Jones maintains that the directive does not mean an end to the flow of personal information between the EU and the U.S., Swire says the new privacy laws will potentially affect "hundreds of billions of transactions"--an issue that will not likely be resolved by similar national legislation coming out of the current U.S. Congress. In healthcare, U.S. lawmakers have been dawdling for years on medical records privacy legislation. Yet for Europeans it is much easier to pass sweeping privacy laws, suggests Swire, because the ties between society and government are so much greater. "In the U.S., laissez-faire is still a stronger ideology than in Europe." A copy of the directive can be found at Swire’s Web site: http://www.osu.edu/units/law/swire.htm.

Polly Schneider is senior editor at Healthcare Informatics.


AUSTRALIA: EYE SURGEON’S DIGITAL HELPER

Patients in Australia can opt for corrective eye surgery that takes advantage of digital decision support and a steady hand. For the past seven years, eye surgeon Noel A. Alpins, MD, of Melbourne, Australia, has used software he developed to guide his laser scalpel as he makes incisions to correct misshapen corneas. His laptop has become as much a part of his operating room paraphernalia as his mask and gloves.

In the past, surgical corrections for astigmatisms could be figured in two ways: the first method gauges the specification based on what kind of corrective lenses improves the patient’s vision; the second measures the actual topography of the cornea. Alpin’s software crunches values from both methods, giving surgeons a set of "what ifs" to examine before and during surgery--and solid numbers to look at following surgery for analyzing outcomes.

During surgery, Alpins consults the patented software ASSORT (Alpins Statistical System for Ophthalmic Refractive Surgery Techniques) to determine the desired numeric value to set for the laser, rather than relying on the laser manufacturer’s recommendations or clinical intuition.

The use of the laptop is routine for him, and the technique is widespread in Australia and gaining acceptance in Ireland, Finland, Canada, the U.S. and Japan. Ideally, Alpins says, the software belongs in the lasers and other ophthalmic equipment. Manufacturers in Germany, the U.S. and Japan are exploring that possibility.

The software package, which enables surgeons to analyze outcomes for refractive surgery, cataract surgery and medical and surgical treatment of glaucoma, costs $4,900 and runs on Windows 3.1, 95 or NT. A scaled-down version called Vectrak, which addresses only the treatment of astigmatism, is priced at $590. Decision-support software for the operating room is also available for other specialties like cardiology.

Susan Lucas, director of marketing for Atlanta-based Surgical Information Systems, says her company makes and markets software that offers surgeons real-time analyses of similar surgical events. "It will say, for example, `Here’s what happened in x, y, and z situation. It’s been found that 90 percent of patients will turn out fine if you choose this approach’," Lucas explains.

Surgical Information Systems’ software is installed in four hospitals in the U.S., including Medical Center East in Birmingham, Ala., which has decision-support built in for all surgical procedures performed in that facility. The software, like ASSORT, allows for the analysis of clinical and financial outcomes.

Kathleen Kimball-Baker is a Minneapolis-based healthcare writer.


INTERNATIONAL DEALS

Medical records software vendor MedPlus, Inc., Cincinnati, Ohio, will partner with European IT Solutions (EITS), a U.K.-based consultancy, to develop a market entry strategy for MedPlus in Europe. EITS will research and develop an indirect sales channel for MedPlus, including the identification of potential business partners in Europe, and will also provide implementation and support services for MedPlus products.

Integration vendor Software Technologies Corporation, Monrovia, Calif., announced a contract with Hammersmith Hospitals NHS Trust in London, to deploy the STC DataGate enterprise integration system. Hammersmith will use the Unix-based product to share data among its five hospitals through a central data repository. According to STC, DataGate supports multiple messaging capabilities, electronic data interchange, encryption and monitoring; and is compliant with several international standards including ASC X12, Health Level 7, ACCORD, UN EDIFACT and S.W.I.F.T. (http://www.stc.com)

Hewlett-Packardhas released a Japanese version of its flagship acute care clinical information system, HP CareVue. The Japanese version will accommodate Kanji and other Japanese character sets. HP has already placed seven orders in Japan for the system, according to HP’s Mike Bunnell. The CareVue system supports electronic bedside data collection, progress notes, care plans and clinical pathways and medication administration; and interfaces for ADT, lab and pharmacy data and bedside monitoring devices. CareVue is available in 10 languages and is deployed in more than 20 countries. (http://www.hp.com)

--P.S.


MICROSOFT TARGETS EUROPEAN HEALTHCARE

At the end of March, delegates from all over Europe braved the chill winds of Harrogate, a Victorian-era spa resort in the north of England, for Healthcare ’98, the U.K.’s largest healthcare trade show. They were rewarded with a keynote speech by live videoconference from a once-unlikely speaker: Bill Gates, chairman of Microsoft Corporation. The importance attached by Microsoft to the conference marks a shift in its attitude to the European healthcare informatics market.

In a flurry of activity since late last year, Microsoft has released European-specific white papers, launched a European arm of its Microsoft Health Care Users Group (MSHUG), begun publishing a European magazine, Windows on Healthcare, and appointed a European healthcare industry manager charged with formulating a European product strategy.

What’s going on? "Europe is a large market that has had a relatively low level of IT investment in recent years," observes Steve Graham, a Manchester, U.K.-based partner with consultancy firm KPMG Health Systems. "Initiatives such as MSHUG specifically aim to take the lessons that Microsoft has learned in the U.S., and apply them to Europe."

Microsoft’s activities to date have revolved around forging links with local partners and standards bodies such as Health Level 7, CORBAmed, and the Andover Working Group. The company has also been finding out exactly what sort of a challenge it faces. "There isn’t a pan-European healthcare industry at the moment," concedes Robert Powell, the company’s Reading, U.K.-based European healthcare industry manager. "It’s a very fragmented marketplace, with 22 countries and 22 different standards for communication and messaging."

As Powell sees it, one of the key tasks of MSHUG will be to provide a forum in which a collective pan-European consensus can evolve. In what is likely to be regarded as a coup for Microsoft, standards expert Georges De Moor, professor in medical informatics and statistics at the University of Ghent in Belgium, has relinquished his role as founding chair of Europe’s CEN TC 251 medical informatics standards committee to chair MSHUG Europe.

According to De Moor, there is a high level of frustration within the European healthcare industry that standards bodies debate issues without ever implementing anything. "Microsoft offers a platform to bring some of those to fruition," he argues. "A major concern is to have solutions that are capable of implementation."

However, Microsoft will have to tailor its U.S. strategy for Europe. "The two markets are different," concedes John Carpenter, Microsoft’s worldwide healthcare industry manager based in Redmond, Wash. "Europe is about a year behind in its acceptance of Microsoft technology. In the U.S., we’re looking at ISVs that are delivering and installing applications--and that’s not the case in Europe."

In part, explains Chris Cherrington, a London-based analyst with Frost & Sullivan, this is because "there’s a lot of reluctance to go down the NT route because of the perception that it’s not yet industrial strength." In the short-term, he believes Microsoft will be held back by Europe’s double problem of preparing for European Monetary Union--which will bring about a single common currency in participating countries--and year 2000 compliance. Longer term, issues surrounding IT funding--largely provided by European governments--and differences between the U.S. and European healthcare systems may also affect Microsoft’s success, according to Paul Goss, a Basingstoke, U.K.-based analyst with Silicon Bridge Research Ltd.

Others are more bullish. "[Microsoft’s arrival in the market] has revitalized a lot of the HIS vendors," notes Noel Daly, practice director at a London division of U.S.-based First Consulting Group. "Standardizing on Microsoft allows them to respond to customer pressures for GUIs more quickly."

Malcolm Wheatley is a freelance writer in England specializing in information technology.


TELEMEDICINE BRINGS CARE TO ISLAND

Patients on the island of St. Kitts have access to only one radiologist, a traveling doc who flies in every two weeks to read exams as part of several stops he makes throughout the Caribbean. Between visits, the island GPs must read the reports themselves or wait until the radiologist returns. Now, St. Kitts’ J.N. Francis Hospital has an ISDN connection with the Dalhousie Medical School’s Center for Telehealth, Halifax, Nova Scotia, which is enabling patients on the island to have specialist review of their cases within 24 hours. The program got started in the fall of 1997 when the governor general of St. Kitts, a graduate of Dalhousie, approached the university for a solution to bring more immediate care to the citizens of St. Kitts, according to Barry Martin, executive director of the Center for Telehealth.

Through funding provided by a St. Kitts bank and the World Bank, the hospital purchased an image scanner and other telemedicine equipment, and is reimbursing Dalhousie radiologists for the consultations, which are scanned and transmitted every night using a 56K desktop modem from 3Com Corp., Santa Clara, Calif. The network will help the island avoid the cost of transporting patients off the island in emergency situations, but this is only just the beginning, says Martin. "In the long term as we increase our service to include other specialties, there will be opportunities for more savings for them."

St. Kitts has asked Dalhousie to develop CME videoconferencing programs for the island’s physicians, and is interested in ultrasound and mammogram consultations as well as interactive sessions with Dalhousie emergency room physicians. According to Martin, St. Kitts may also find revenue-generating opportunities in providing telemedicine services to smaller islands nearby, and the Dalhousie connection should help St. Kitts attract more tourists by marketing the island’s access to specialized medical care.

To facilitate and support a growing international telemedicine program, the Center for Telehealth will rely on more than nine years of experience in telemedicine at Dalhousie. The center is in the process of installing a 51-site telemedicine network in Nova Scotia linking regional hospitals and clinics with the main tertiary care center at Dalhousie. The Nova Scotian government is funding the project, and has agreed to reimburse specialists for the consultations. The center has also partnered with 3Com as its core networking vendor, and is exploring technologies like ATM to speed up the links; MedVision, Minneapolis, and Zydacron, Manchester, N.H., are providing the videoconferencing technology. Martin says Dalhousie will be able to expand its telemedicine program to other Caribbean sites for a minimal investment: "We expect if we can put the system on another two islands in the next year, we’ll generate profits."

--P.S.


IS PURCHASES COMPLEX IN U.K.

After 168 years, Carlisle, a small town in northwest England, is getting a brand new hospital. Funding of the Cumbrian Infirmary--an investment of 80 million pounds or U.S.$128 million--was a unique partnering of public and private monies and set a benchmark as England’s first hospital building project funded by a public bond issue. However, the monies approved do not cover the costs for much-needed capital investments such as radiological equipment, computer systems and communications.

Although improving services for patients by upgrading IS equipment is at the top of the wish list at the new facility, Paul Wiggins, head of information services at Cumbrian, explains the difficulty in procuring products under the U.K.’s National Health Service: "We have a quandary facing us concerning any computers or equipment improvement in our system. If these were to be acquired through NHS monies we would need to make a formal request and then go through the bureaucratic wait of a government vote to approve funding and purchase." Since the U.K. provides free, universal healthcare to all of its citizens--a system that is becoming increasingly constrained--funding for IS purchases is scarce.

Ultimately, Wiggins says, getting a new computer system translates to one of two choices: waiting for the government to vote on funding, or seeking additional capital from private sponsors. While no one denies the importance to health delivery of better electronic communications, getting physicians to buy into the concept for their practice has yet another twist.

In England, physicians have an earnings cap in their NHS contract. To augment their salary, physicians may become consultants offering "private practice" services, but there is an earning cap for these services as well. As a result, Wiggins explains, primary care physicians cannot (or are reluctant to) generate the cash needed to invest in IS.

The Cumbrian IS department operates at two sites with 400 PCs that are "mostly networked," ranging from older 386 models to the latest Pentium processors, according to Wiggins. His vision is to eventually have state-of-the-art tools. "We want to move to electronic record keeping, communicate images back and forth and standardize care protocols." Given the government funding issue, this will likely be accomplished through leasing arrangements, a common practice in the U.K.

Wiggins says leasing will allow hospital staff to learn the ropes of a new system and experiment with technologies such as bedside notepads and voice-activated systems. Learning what would work best "without actually having made the investment and then being stuck with something that’s not right for us," he says, is still a positive step in the transition from old to new. The 474-bed Cumbrian Infirmary is scheduled to open in the year 2000.

Barbara Hesselgrave is a Virginia writer specializing in healthcare.



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