Originally Published MX July/August 2005
IT IN HEALTHCARE
Coming Closer: The Future of Integrated Healthcare ITAs the ideal draws nearer to reality, medtech manufacturers should not miss the integration bandwagon.
Joseph Vinhais
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| The ubiquitous paper patient record, symbol of inefficient clinical management practices that are gradually being edged aside through the adoption of advanced health information technologies. (click to enlarge) |
Over the past two decades, the development and adoption of information technologies (IT) have advanced at breathtaking speed. The first personal computer was built 30 years ago. Many people remember when the PC first arrived in their office, and now PCs are standard equipment in almost every office in the world. However, exponential advances in the ways information is exchanged, and people and equipment are connected, have created both opportunities and conundrums.
Nowhere are these connections and information exchanges more delicate than in the healthcare industry. Healthcare organizations must temper the use of personal health data to advance healthcare efficiencies with the obligation to secure exchanges of such data in order to protect patient privacy and safety. They need electronic environments in which data are easily available to appropriate participants in the healthcare delivery process, but at the same time they have to ensure that conduits for health information exchange comply with the patient privacy requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Many healthcare-related IT systems are now in operation. These include the systems hospitals use for administration and patient care; the systems physicians use for patient scheduling, reimbursement, and maintaining electronic medical records; and the systems medical device and pharmaceutical manufacturers use in running their businesses, particularly in the areas of process and quality control. Although these healthcare stakeholders may regularly install new software and IT hardware, many healthcare providers and medtech manufacturers continue to depend on paper-based systems to manage the aforementioned tasks. And despite the high level of IT connectivity that has been developed, many of the electronic systems in place operate in a silo or do little more than duplicate electronically the information contained in paper-based systems.
At some point, regulatory, market, and other pressures will force all of these healthcare IT systems to integrate. This article examines the present capabilities of healthcare IT systems of various types, considers their path of evolution, and appraises their potential for becoming fully integrated, emphasizing how medical technology manufacturers can and should fit into the integration picture.
Healthcare IT Today
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| Figure 1. In spite of the prevalence of computerized systems in virtually all healthcare-related settings, the adoption of interoperable software and use of connectivity solutions remain spotty at best (weakest areas are indicated by faint icons). (click to enlarge) |
Some clinics, physician offices, and hospitals are quite highly automated today, with minimal paperwork; however, paper-based systems predominate in most places. The ubiquitous color-coded manila folder is still the physician's mainstay.
Nonetheless, physician offices increasingly are becoming electronically based, and physicians more technologically astute. Physicians learning to exploit new computer systems can be observed carrying half-sized notebook PCs to and from patient rooms that are standardized such that each room has a matching adapter into which the clinician can plug the computer. Connections may be both wired and wireless. Office personnel scan historical paper records into the system so that a physician can pull up all past visits instantaneously. Lab results also return electronically and are readily available at follow-up visits, even if such a visit is just three days later. Physicians submit prescriptions electronically, directly to a hospital or drugstore pharmacy, thereby eliminating the infamous problem of illegible prescriptions. With patient consent, physicians can forward patient health data to consulting specialists. The system simultaneously creates referral paperwork electronically when required by the patient's preferred provider organization, as outlined by the system.
Some healthcare providers are using IT with tremendous efficiency and realizing many of the potential benefits of these systems. In particular, they are finding that they can use technology to implement a fully patient-centered approach to healthcare. Medical device manufacturers could add tremendous value to their products if they could link into this same system and connect with physicians directly. This would be great for sales and marketing, of course; new- product time to market and company share price might improve. What is more important for healthcare delivery, however, is that manufacturers could also send information generated during factory production directly to physician offices. For example, a manufacturing system might find the introduction of a defect in a particular production run. If integrated with patient-care systems, that manufacturer's execution system could immediately notify users of the affected device about the problem, bringing advantage to both the provider and the patient.
Forerunner physician practices are enjoying many benefits from technologies that are available to medtech manufacturers as well, but that these manufacturers underutilize. The benefits these physicians enjoy include greater timeliness of information, error-free communication (no interpretation of chicken-scratch notes necessary), and expedited billing and payment. Information exchange is facilitated; everything is legible, easy to maintain, and accessible from one screen. All elements of patient history tie together, including trends in the patient's condition, the record of diagnosis and prescription, and more.
Manufacturers can benefit from IT in much the same way. Manufacturers would profit from more-timely information that could speed decision-making. Error-free communication would help ensure that every step of the manufacturing process runs smoothly and correctly—the right revision to the right person, use of the right equipment and the right material at the right time, and so on. Manufacturing-company personnel would find it easy to look up information and share it with the appropriate colleagues. Records would be legible, without chicken-scratch values recorded on job-ticket travelers and indecipherable nonconformance records. Data would be readily available for trending and correlation.
Using IT in the manufacturing environment makes perfect sense. Nevertheless, according to anecdotal accounts and surveys conducted by the author's company, more than 80% of the information collected and distributed in manufacturing is paper-based. It is ironic that manufacturing companies should be so backward in handling these data, because 90—95% of that information is produced electronically.
Technology now exists that helps all sorts of regulated medtech manufacturers meet current requirements and mandates, yet too few companies have the vision to develop paperless systems that will take care of future needs. Those manufacturers that can create a manufacturing compliance data infrastructure, or platform, to ensure connectivity and interoperability well into the future will be benefiting themselves and also the other players in the healthcare system—providers, payers, and patients—all of whom are mutually dependent on good data availability. True technological integration will streamline communication and data exchange, and promote public health.
Toward an Integrated Ideal
Connecting for Health (New York City) is a broad-based organization that unites government, medtech industry, and healthcare industry leaders in tackling the technical, financial, and policy challenges that are inherent in efforts to effect IT transitions. It has issued a healthcare connectivity roadmap that outlines ways that public- and private-sector healthcare institutions can work together to address those challenges by:
- Achieving connectivity via the creation of a solid technical framework.
- Addressing financial barriers to quality improvements in healthcare via the development of incentives to promote enhancements.
- Communicating with and educating the public in order to help people embrace the changes as they come about.1
In its roadmap document, Connecting for Health asserts that stakeholders can best address the last of these points by encouraging consumers to access their health information and by directing resources toward promoting the benefits of electronic data. Electronic data are already used successfully in healthcare and are integrated to some extent. Examples of electronic data systems for healthcare include the electronic health record (EHR), FDA's adverse event reporting system (AERS) and MedWatch system, the quality improvement organization, and the QualityNet Exchange.
EHR systems are becoming widely used, but they vary from place to place and from product to product. In addition, EHR functionality varies widely. Basic system functions include clinical documentation, patient medical records, messaging, patient demographic data, and the ability to view laboratory information. More-extensive options may also encompass drug ordering and management, public health reporting, adverse-event reporting and information, and protocols and standards of care. In most cases, patients can access their own medical records via a secure route. Finally, a well-designed EHR can interface with medical-practice management software. The federal government is currently working toward standardizing a national EHR system with most of these features.
The primary goal of AERS is to protect public health by providing the best implements for storing and analyzing safety reports. AERS serves as an electronic information database. It supports FDA's postmarket safety surveillance program for all approved drug and therapeutic biologic products. Theoretically, all information in the EHR should be transmissible to AERS and vice versa.
Similar to AERS, MedWatch is an FDA voluntary reporting system that puts out safety alerts for pharmaceuticals, dietary supplements, biologics, and medical devices.
The Centers for Medicare and Medicaid Services (CMS; Baltimore) directs a network of 53 quality improvement organizations (QIOs) across the United States. These organizations work with both consumers and caregivers to improve healthcare systems and ensure that care is timely and appropriate. QIOs aim to make certain that federal programs reimburse medically necessary procedures and treatments exclusively. They focus primarily on underserved populations. In addition, they investigate quality-of-care complaints for beneficiaries. QIOs operate best if they have direct access to patient records and adverse-event information.
The QualityNet Exchange (QNet Exchange) is a Web site designed to facilitate this transfer of information. Specifically, QNet Exchange is a secure Internet vehicle by which a client system can transfer information to the doctors' office quality information technology (DOQ-IT) application, which was born of a project to encourage the use of IT and the EHR in physician offices. Its framework is designed to run data checks before uploading information. This is important because QNet only transfers data; it does not store anything.
The EHR, AERS, MedWatch, QIO, and QNet Exchange systems, considered together, exemplify how integration can facilitate a patient-centered approach to healthcare.
Pharmaceutical and medical device manufacturers are key players in the healthcare cycle that, optimally, should connect with AERS and QIOs. One way they can do this is by establishing a manufacturing compliance platform. Such a platform enhances the capabilities of several enterprise systems and technologies, including the manufacturing execution system (MES) that controls all production information.
The MES electronically hosts the device history record (DHR) and batch record (BR), both regulatory requirements, as the eDHR and eBR. These records also connect to other systems within the organization, such as the corrective and preventive action (CAPA) and customer complaint systems. This direct connection between pre- and postmanufacturing data linked to complaint management systems allows a manufacturer to report adverse events electronically—thus, in a timely manner—while immediately understanding the corresponding risk posed by, and level of customer exposure to, a defective product. The objective in such an instance is to enable physicians and other clinicians to have information regarding adverse events at their fingertips when selecting a drug or device for use in a treatment or diagnostic plan.
Possibilities down the Road
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| Figure 2. The future of healthcare information technology systems related to clinical quality and medical technologies. With expanded use of the Internet and secure firewalls, there will be a dramatic increase in the number of entities exchanging healthcare information seamlessly and instantaneously. (click to enlarge) |
As healthcare IT continues to evolve, so does the regulatory response of the federal government. Regulations, standards, and published guidances serve as anticipatory actions to help prevent foreseeable problems with electronic information exchange. These include, notably, the government's support of a national EHR system and 21 CFR Part 11, which covers electronic records and signatures as regulated by FDA.2 Today's high level of regulation compels manufacturers to move to electronic systems in order to control the costs of compliance. Moreover, the International Committee on Harmonization (ICH) and Global Harmonization Task Force (GHTF), joint government-industry projects for IT advancement in the pharmaceutical and medical device industries, respectively, both see integration as a key factor in risk management and quality control.
Production data become much more valuable as CMS puts pressure on medtech manufacturers to lower the cost of medical goods. Once the more blatant, high-visibility production costs are dealt with, reducing costs year after year by small percentages requires a much more granular level of process information than most manufacturers are equipped to generate currently. Granular information means, for example, that a manufacturer would have data detailed enough to quantify the cost of placing a product within a container before it is advanced to the next step in a manufacturing operation. This level of detail would also facilitate premarket testing.
Other industries already operate with this level of detail. Leading U.S. automakers have mandated that suppliers reduce prices 10% annually, which in turn forces those suppliers to reduce their own manufacturing costs to maintain margins. To contain costs, manufacturers, including those in the medtech industry, can implement several valuable tools, such as lean manufacturing and six sigma. Because of regulatory requirements, medtech companies, regardless of the tool employed, absolutely must produce data of high integrity.
The next wave of technology for enterprise systems will involve developing software that supports a service-oriented architecture (SOA).3 Software vendors will have to reframe their solution architectures to enable them to interoperate with other applications through programming invisible to the user. In other words, in an SOA environment, users would see the applicable components of each software package, and these components would be able to interact without human intervention. Thus, users would no longer be switching between applications or keeping multiple applications and multiple windows open on their computer screens.
A user could work from one window such as a browser able to accommodate the connection of any accessory device, such as a cell phone, personal digital assistant, computer, or network appliance. All systems would update automatically and simultaneously. As vendors move toward this SOA environment, more and more applications should become truly interoperable without the need for customization, integration, and extended validation—and without entailing the costs of those operations.
Current healthcare IT systems can evolve to meet future needs if manufacturers running them take full advantage of the technology available now. This requires a carefully planned and sustained effort, which will inevitably run into challenges as some existing practices will have to be revised. As payback for this effort, however, manufacturers will be able to considerably improve product delivery and customer service, as well as significantly reduce the cost of compliance and the cost of manufacturing overall.
A Vision of the Future
Imagine: A medical device manufacturer's nonconformance and CAPA system identifies a potential device problem in the field. During further investigation and review of the eDHR, the system, within seconds, narrows down the suspected product problem to a two-day production point occurring the week before. The eDHR system, in coordination with the manufacturer's warehouse management system, identifies distribution points. The system immediately sends a message to the hospitals and practitioners served from that distribution center, notifying them of the suspected lots, and requests immediate identification of usage, if any, from the doctors' office quality (DOQ) EHR system. This exchange of information benefits the physician and patient instantly. Meanwhile, the manufacturer enjoys the reduction of liability, reduction of expense, and the benefits accruing from enhanced customer service.
Another scenario: Through an EHR system, a physician in a private office designs a treatment plan for a patient that includes a prescription for a particular drug. Upon selecting the drug electronically, the DOQ EHR system automatically sends an information request to AERS. AERS immediately sends back a message to the doctor documenting the occurrence of several adverse events over a relevant period and provides a link enabling the doctor to look up the adverse events to understand their applicability to the patient's case. This exchange of information also benefits the physician and patient instantly. The pharmaceutical manufacturer gains by being able to respond to their needs particularly quickly and efficiently.
In both of these situations, the information exchange takes place over a secure Internet connection and concludes within seconds or minutes rather than taking, days, weeks, or months. The number of lives affected by adverse medical events would decrease drastically if connected and interoperable systems were in wide use, making short work of identifying, verifying, analyzing, tracking, and reporting suspected adverse events.
Patient safety is a vivid example of an area of health practice in which the integration of healthcare IT systems will have dramatic positive effects, but it is just one example. Many medtech manufacturers will find it imperative to have up-to-date healthcare information technologies in place. Some will choose to strategize on creating a manufacturing compliance platform able to integrate into new healthcare IT systems as they become available.
References
Joseph Vinhais is vice president for regulatory compliance at Camstar Systems Inc. (Charlotte, NC), a provider of enterprise manufacturing execution and quality systems software for medical device manufacturers.
Copyright ©2005 MX
