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September 2011 Editors: Sunquest Information Systems is not only following the rules, it’s embracing them—even though the company need not pay them any mind. And it has its Lean Compliance program to thank for that. “For many companies within this industry, [government] regulations are seen as constraints,” says Patrice Nedelec, Sunquest’s vice president of quality, regulatory affairs, and program management. “We are at the other end of the spectrum.” Sunquest recognizes the benefits of voluntarily adhering to federal rules and regulations when developing software, Nedelec says. For example, although not required, about two-and-a-half years ago Sunquest began adapting the development of its FDA-classified class I and unregulated health care information technology solutions so those products would meet the requirements of class II devices. In general, the class II rules require that manufacturers submit rigorous documentation that explains the design of the product and that the FDA be notified of any problems with the product that could become a public health issue. Before that, Sunquest was voluntarily developing its solutions to meet class I regulations, applicable to devices considered to be of lesser risk. Developing products that adhere to these regulations leads to higher quality products and, ultimately, better patient care, Nedelec says. Sunquest is complying with such federal regulations, in part, through its Lean Compliance program, initiated in 2009. The program applies Lean manufacturing principles to the development of software applications. (Derived from automobile manufacturer Toyota Motor Corp., Lean manufacturing is a management philosophy that focuses on removing waste from the production process by removing steps that add no value to the end result.) At Sunquest, the goal is to find the simplest way to develop a safe product and bring it to market, Nedelec says. “We remove all unnecessary steps as part of those processes.” For example, until 2009, Sunquest used two levels of design documents—a high and a low—which defined in detail how a software solution is supposed to function and made it easier to test that solution. The company generated both levels of documents manually. Now the company creates just one level of design documents, and, in part, they are generated automatically by a state-of-the-art software system, Nedelec says. Sunquest has also automated its quality control testing process. Increased use of automation allows Sunquest to focus more of its efforts on enhancing quality during the product development process, Nedelec continues. And each stage of the product development cycle involves an evaluation of the potential risk for errors in the context of a user setting. In addition, an independent Sunquest team that reports to the company’s quality and regulatory affairs department works with clients to test solutions for patient safety and error prevention. “When we develop requirements for our products, we consider how the customer is going to use them in the intended environment,” says Kelly Feist, Sunquest’s vice president of marketing. By understanding the problems that customers are trying to solve and the constraints within their workflows, Feist says, Sunquest can build a more effective and efficient solution that adheres to the quality standards detailed in FDA regulations. By making this process smarter, and thereby faster, Sunquest can conduct a greater amount of end-user testing on products before they’re released to market and still get those products to market more quickly than was possible just a few years ago. Product cycle times across all categories have been reduced by about 25 percent since incorporating Lean manufacturing principles, says Nedelec. “Not only are we faster to market,” he adds, “but the quality of the products that we are delivering is significantly higher.” Halfpenny Technologies has entered into a demonstration project for a lab hub with the Georgia Health Information Technology Regional Extension Center. The lab hub is intended to facilitate a seamless and secure exchange of clinical data between members of the extension center to support Georgia’s statewide health information exchange deployment initiative. “Utilizing a vendor-neutral lab hub will not only streamline clinical data exchange for GA-HITREC members but also enable them to meet lab-specific meaningful use certification requirements for physician EMR adoption, including CPOE, structured results reporting, and quality reporting,” says Dominic Mack, MD, director of the GA-HITREC and deputy director of the National Center for Primary Care. Halfpenny initially will make the lab hub available to a select group of the extension center’s constituents, including Solstas Laboratories and LabCorp. Halfpenny Technologies The FDA is seeking input on its proposed approach to oversight of select mobile applications that are specific to health care and designed for use on smartphones and other mobile computing devices. “The use of mobile medical apps on smartphones and tablets is revolutionizing health care delivery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.” The draft guidance focuses on a small subset of mobile medical applications that may influence the performance or functionality, and potentially the safety, of regulated medical devices. This includes mobile medical applications that are used as accessories to medical devices already regulated by the FDA, such as an application that allows users to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or a mobile tablet. The guidance also applies to mobile medical applications that transform a mobile communications device into a regulated medical device by using attachments, sensors, or other functionality, such as an application that turns a smartphone into an electrocardiograph machine. Under the proposed guidance, a manufacturer would register annually and list the mobile medical applications it is marketing and supply specific labeling information with the products. Manufacturers would have to meet quality system requirements to assure that their products are safe and effective and establish consistent methods to design, produce, and distribute their devices or software. Furthermore, mobile medical application makers would be required to report to the FDA information about serious adverse incidents related to use of their products. The FDA is seeking public input on its draft guidance. Comments and suggestions can be submitted to the FDA at www.regulations.gov until Oct. 19. The draft document was published in the Federal Register on July 19. IRobot Corp. and InTouch Health have signed an agreement to explore opportunities for using iRobot platforms in the health care arena. IRobot develops robotic technology-based solutions, including the popular Roomba automated cleaning robots. InTouch Health manufactures remote-presence telemedicine systems. iRobot Corp. Medical transcription and software vendor Nuance Communications has purchased Webmedx to strengthen its position in the medical transcription services marketplace. Nuance will market Webmedx’s clinical documentation services and technology to health care organizations. The company will also incorporate Webmedx’s natural language processing-driven Quality Analytics application into its offerings. In a separate announcement, Nuance reported that it has entered into a 10-year-long partnership with the University of Pittsburgh Medical Center to develop speech-recognition and clinical language understanding-enabled technologies. The latter allows a computer to read and process text and abstract data. Under terms of the development agreement, Nuance and UPMC initially will focus on clinical language understanding-enabled technology and decision-support tools intended to help clinicians capture relevant clinical details when dictating notes for the medical record. The partners are also exploring data mining specifically tied to the federal government’s meaningful use requirements for electronic records and the possibility of creating tools to search and analyze the contents of clinical document repositories. Nuance will market solutions developed as part of the agreement. Nuance Communications Siemens Healthcare Diagnostics has introduced the Syngo Lab Data Manager laboratory data-management system. The product is designed to work in conjunction with multiple instruments, a laboratory information system, and Siemens’ data center. The browser-based system offers autoverification; advanced quality control capabilities, such as applying Westgard and custom rules to flag questionable results; and remote services provided via the Siemens Data Center. A single interface links the system to the LIS. Syngo supports access for up to 25 concurrent users on a PC network. Siemens Healthcare Diagnostics The American Medical Association has introduced AMA Coding Online, an interactive Web site that offers a comprehensive set of the organization’s coding applications and services for an annual subscription fee. “The all-new online products are based on best-selling AMA coding resources,” says Robert Musacchio, PhD, senior vice president of AMA Business Products and Services. “Regular electronic updates through AMA Coding Online ensure these Web-based products stay current with the latest information that users need for accurate medical coding.” AMA Coding Online will include Web versions of the association’s CodeManager, CPT Assistant, RBRVS DataManager, CPT Changes, and other coding products. Aprima Medical Software, formerly iMedica, has acquired the revenue cycle management company Health Care Strategies. Aprima, a provider of electronic health record and practice-management systems, has operated under a partnership with Health Care Strategies since 2006. Aprima Medical Software Dr. Aller is director of informatics in the Department of Pathology, University of Southern California, Los Angeles. He can be reached at raller@usc.edu. Hal Weiner is president of Weiner Consulting Services, LLC, Florence, Ore. He can be reached at hal@weinerconsulting.com. |
Why Sunquest leads with Lean