Information Technology usage in the healthcare ecosystem is pervasive and dates back to some of the earliest stages of development of the computer industry. In fact, the Healthcare Information Management Systems Society, better known as HIMSS, celebrates its 50th anniversary in 2011. Design concepts for the first computerized medical record system were developed by Lawrence L. Weed, a physician at the University of Vermont, in the 1960s. In addition, many of today’s largest providers of electronic medical record software can directly trace their technology roots to the Massachusetts General Hospital Utility Multi-Programming System (MUMPS), a programming language and data management model originally developed in the 1960s.
The earliest stages of development of what would come to be known as the Internet was announced in 1969, when four computers located in geographically distant locations successfully exchanged information over an electronic network. Over the next decade, work on a standard way to interconnect computers on this network culminated with the release of the Internet Protocol, or IP, in 1981. In December of 1990, Sir Tim Berners-Lee introduced the world to the hyperlinked information model of the HTML programming language of the World Wide Web built on top of the Internet Protocol, which enabled information to move across boundaries with a click of the mouse. This was followed by development of the Mosaic graphical web “browser” in 1993 at the University of Illinois, which made it easy for ordinary people to use the power of the World Wide Web. In 1995 James Clark, one of the co-founders of Netscape, launched a company known as Healtheon, later merged with WebMD, that had the goal of creating software that would place the Internet and his company’s portal between physicians, patients, and health care institutions in order to eliminate unnecessary paperwork and facilitate networking and communication.
The ideas behind these seemingly isolated events spanning three decades now sit together center stage in the quest to improve quality of care and efficiency for the global healthcare industry. Combination of advanced information technologies, electronic health records, and the Internet are promoted and encouraged by governments worldwide, including the significant resources associated with electronic health record adoption in the United States as part of the 2009 HITECH legislation.
The Highly Regulated World of Healthcare Technology: a Big Challenge for IT Companies
The information technology industry is known for being fast moving, aggressive, extremely competitive, and subject to rapid and often unpredicted upheaval and change. Many of the early leaders in the development of the industry have succumbed to rapidly shifting technologies and economic pressures driven by relentless pursuit of better, faster, and cheaper alternatives.
In contrast, the highly complex and regulated healthcare industry must move at a much slower pace because its products are required to be thoroughly tested and analyzed, and undergo risk and risk mitigation assessments as part of product development before the technologies can be marketed and deployed.
The “ship early and ship often” or “new releases are a feature” stereotypes often associated with many familiar information technology providers is anathema to regulated technology use and to the regulators, who demand that suppliers of technology used for medical purpose prove the products to be “safe and effective” for patients and healthcare professionals. The Anson Group can assist IT companies entering the healthcare and medical technology space navigate the regulatory compliance hurdles that characterize the challenges of the industry.
Anson supports:
- Mapping regulatory compliance strategy to business strategy
- Evaluating potential partners regulated as medical device manufacturers for compliance
- Assessing regulatory compliance as mergers and acquisitions due diligence and for strategic impact on a company’s non-regulated operations
- Assessing roles and responsibilities for companies that serve as suppliers to regulated medical device manufacturers
- Assessing intended use claims for IT companies who desire to avoid direct FDA regulation: understanding the boundaries between unregulated and regulated products, and developing strategies on how not to cross them
- Educational training on FDA regulation requirements that apply to medical technology
- Developing product commercialization strategies and requirements
- Preparing regulatory product approval and clearance submissions
- Preparing for meetings with regulatory agencies
- Remediating compliance issues
