Chapter One
Market Background
Change is the law of life. And those who look only to the past or present are certain to miss the future.
-John F. Kennedy (1917-1963), thirty-fifth President of the United States
E-Health
What is e-health? Is it merely a fashionable buzzword from the 1990s? Is it a new way for marketing professionals to distinguish their healthcare offerings, or just a way for them to repackage their old offerings? E- (electronic-) health is all about technology. E-information is today''s revolutionary market tool across all industry sectors. The term tools is used in the context of electronic processing of a particular operation. It is the technology of communicating, processing, and deriving information in electronic form. E-information will continue to impact the healthcare industry. Although the market players (patients, providers, payers, plan sponsors, and other third-party service providers) within the healthcare continuum (HCC) remain intact, how each functions within the continuum along with their diagnostic tools and treatment protocols continues to change.
What has changed? What is new? E-health initiatives essentially implement new, evolving forms of electronic communication and processing tools in our current healthcare system. As e-health initiatives continue to emerge, we may learn better ways to redefine the roles of our market players. In fact, we should expect some traditional roles and processes to continue to change in scope as technology modernizes the healthcare industry.
Evidenced-based medicine is being presented as an e-health opportunity. Evidenced-based medicine can be defined as
The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine requires the integration of individual clinical expertise with the best available external clinical evidence from systematic research and our patient''s unique values and circumstances.
The key e-health initiative would be the assimilation of external clinical evidence. Most providers are creating internal electronic systems to be more efficient within their organizations. Providing structure to health clinical outcomes from external sources would impact how we make decisions in healthcare. The audit concerns would revolve around ensuring the security and integrity of the external information being integrated with internal evidence. This opportunity should be developed within a contemporaneous internal audit control environment.
We often hear the term efficiency directly correlated to e-health. If someone needs to obtain a prior medical record of a patient in a traditional paper record system, it requires physically going into a file room. If someone needs to study how a patient or a series of patients responded to a treatment plan, she must engage in a set of manual processes to achieve a certain level of intelligence from the information. In other words, because a paper system is manually driven, it requires more labor hours to arrive at a particular outcome.
E-health initiatives provide the opportunity to reduce the labor associated with the retrieval of healthcare information. Similarly, electronic tools that sift through large amounts of data at a speed and consistency unmatched by any human provide the opportunity to reduce the labor associated with the processing and reading of each paper page of information.
But is there any guarantee that e-health initiatives will make all aspects of healthcare processes more efficient? In a recent audit of an e-health system, the task of organizing a patient''s health information and determining what, where, when, why, and how a patient was treated clinically and financially was found to be more time consuming than that same task in a traditional paper system.
The number of e-health tools that simply do not have a clear e-audit trail within their systems is alarming. If a bank implemented similar types of e-financial tools, then someone could walk into its vault at any time without any tracking of his activities. The audit of a 500-bed hospital in which the new state-of-the-art e-health system had the ability to track additions and deletions of a medical record showed that the system design did not include a control to prevent a user from deleting or adding an entire medical record episode. Another 250-bed hospital purchased a system that in essence merely tracks the activity of the last user. For example, someone could enter a medical record and record a narrative. Another user could walk in behind her and rewrite her narrative, and the system would keep track of only the last entry and have no record of the original entry. On the financial side, there are systems in which the billing side will purge account activity once the account is closed. If that provider was subjected to any audits, it would have no ability to follow the money. Imagine being presented with an audit from Medicare or Medicaid that wanted last year''s accounts in which claims were submitted. In your response, you would have to clarify that the system you purchased automatically purges all accounts and you can no longer retrieve the information. Having a system that leaves your organization noncompliant with the ability to audit your claims is a significant high-risk situation to be in.
E-health is about digital healthcare data in electronic form that designated market players generate, transfer, and utilize. The technology behind e-health consists of digital tools, electronic tools, and network exchanges conceived and built to facilitate the transfer of such data. One of the foremost ongoing concerns about e-health lies in the management of its technological growth. How, for example, will we manage data when the materials and equipment (hard drive storage technology) used to create that storage become obsolete? Another significant concern regarding e-health involves the effect that varying rates of technology adoption among the market players will have on the healthcare system. The concept of interoperability thus refers not only to market acceptance of electronic media utilization but also to an environment in which the market standard drives consistent use of current technological capabilities.
From an audit perspective, the critical question concerning e-health focuses on its impact on market roles and processes. We will examine this impact in closer detail.
How Is Electronic Information Created?
The following is a very brief overview of the history, terminology, and acceleration of developing technologies. The evolution of technology provides the foundation for the auditors'' information diagram in Exhibit 1.1. The latter half of the twentieth century has seen an explosion in new technology. While they may have started as government experiments or research projects, the results of the development projects have become a part of our everyday lives. Everything from television to computers to cell phones is a result of this technological revolution. We live in a digital age, and it is defined by technology and innovation. The tools used today to execute various functions within the healthcare domain are a result of this digital age. They can be classified into the following categories: electronics, computers, networks, software, and storage.
The digital age really began with the development of the transistor in 1947 by Bell Laboratories. Transistors are semiconductor devices that can manipulate electronic signals. They are the basis of all digital circuits, including microchips, which use millions of microscopic transistors to power everything from calculators to cell phones. Transistors are the building blocks of all electronics, including computers.
The transistor made building electronics faster and cheaper, and allowed manufacturers to build smaller and smaller devices. Electronics that were once the size of a room are now able to fit in the palm of our hand. The advances over the years have influenced the tools used in healthcare and have increased the accuracy and quality of healthcare. From digital thermometers to MRI machines, all aspects of healthcare are affected by the growth of electronic tools.
In speaking of electronics, one cannot ignore the most significant electronic tool: the computer. While computers predated the development of the transistor and modern electronics, those early vacuum-tubed giants were really used only in government and corporate research. With advances in digital circuits, computers became cheaper, faster, and more available than ever before.
This in turn spurred the growth of new ways to use computers as software and programming languages were created and implemented. For example, the introduction of FORTRAN (short for the IBM Mathematical FORmula TRANslating System) in 1957 enabled a computer to perform a repetitive task from a single set of instructions by using loops. Developed in the early 1950s by the Stanford Research Institute, with funding from Bank of America, ERMA (Electronic Recording Machine Accounting) explored the automation of check handling and posting. When it went into production in 1959, Bank of America had a reliable solution to automate checking accounts. To get there, it had to overcome a number of hurdles, one of which was finding a solution to automate inputting of check information. This led to the creation of magnetic ink character recognition. Now checks could be preprinted with magnetic-ink font characters that could be read automatically or by humans. These are still visible at the bottom of the checks we use today. In 1960, COBOL was introduced for business use; LISP, for writing artificial intelligence languages; and Quicksort, for increasing the speed of data sorting. A few years later, the introduction of the American Standard Code for Information Interchange (ASCII) enabled machines from different manufacturers to exchange data.
Computers also had to be able to store the information they processed. In the beginning, this was done with punch cards. Advances in data storage technology grew as the need for more storage was created by the advances in computing. The more power the digital circuits or microchips had, the more processing they could do, which led to more information being processed and the need for larger storage capacity. In the 1950s, IBM introduced disk storage technology to the world when it launched the IBM 305 RAMAC, which could store 4.4 MB on 50 24-inch platters back in 1956. We have come a long way since the IBM 305 RAMAC, as storage area networks (networks of shared storage devices) can store terabytes of information. We carry around flash drives that hold over 4 GB and are smaller than a pack of gum.
Storage is a vital component of an auditor''s checklist for any e-health system, and the ability to ensure the confidentiality, integrity, and availability of the information stored is vital.
The final piece of the puzzle was networking, or the ability to have computers communicate with one another. This really began in 1960, when AT & T designed the data-phone, a commercial modem that converted digital computer information into analog signals. The data-phone set the stage for a series of advancements in data transmission over the next decade. ARPANET was born in 1969, from the Defense Advanced Research Project Agency of the U.S. Department of Defense. Its goal was to enable communication between research laboratories, universities, and the military.
ARPANET was in fact the predecessor to the Internet, but it did not gain the public''s attention until the early 1990s. In 1975, Telnet became the first publicly available commercial network service. Established in 1980, USENET is one of the oldest communication systems still in use today. At its inception, USENET allowed users to post and reply to public messages more than a decade before the World Wide Web by relying on the UUCP protocol to copy messages from one server to another. In 1983, the military portion of ARPANET was broken off as a separate network, MILNET. Before the break off, ARPANET was comprised of 113 nodes; today it is estimated that more than 1 billion people use the Internet. ARPANET became what we now know as the Internet.
The Internet is now a worldwide publicly accessible series of interconnected computer networks that exchange data using the Internet Protocol suite. The Internet Protocol suite (sometimes referred to as TCP/IP, based on its two most important protocols-Transmission Control Protocol and Internet Protocol) is a set of communication protocols that allow for standardized communication between hosts connected to the Internet or other private networks. The Internet serves to transport a variety of information using services like the World Wide Web and electronic mail.
The World Wide Web, created by Tim Berners-Lee, is comprised of a series of interlinked documents accessible via the Internet. The Hypertext Transfer Protocol (HTTP), a member of the Internet Protocol suite, allows for the transfer of information on the Web. The commercialization of the Web in the mid-1990s sparked online commerce as it allowed companies to create a presence online. Today, the Web has become a ubiquitous technology along with electronic mail.
Electronic mail, often abbreviated as e-mail, is a method of exchanging messages over a communication network such as the Internet. Having its roots in a variety of protocols, it allows users to compose, send, and receive messages.
Although adoption of new technology depends on the successful integration of a variety of components, it is clear that components do not evolve at the same rate. What does this mean to the healthcare industry?
Exhibit 1.1 demonstrates the categories that should be identified in the scope of auditing an information infrastructure.
From an information perspective, the auditors'' assessment should include questions that help identify the current electronic infrastructure of electronic information communications. For example, a checklist of questions might include:
Identify the current electronic infrastructure of information communications.
Identify what computer tools are being used to communicate information.
Identify what components are currently being used.
Identify the process flow of the network.
What software and languages are we currently using to communicate information?
What types of storage devices do we use?
For each item in the checklist, auditors should understand why the designated tool is used, where the tool is maintained, how the tool is implemented, and whether the tool uses the most appropriate framework and structure, to determine whether the information extrapolated from an e-audit will meet the standards of sufficiency and relevancy.
Information Technology Considerations
Auditing the systems and processes of an organization that utilizes information technology requires a general understanding of its technological components. In addition to a subject matter expert, a successful audit team will need to adopt someone who has an appropriate understanding of technological components such as operating systems, hardware, software, change or version control activities, and security devices.
An operating system is the software that allows the computer to run and process information on behalf of its user. Examples include Windows, Unix, Linux, and the Mac OS. An operating system therefore enables users to run various applications, such as an electronic healthcare record to manage information about a patient''s care. Within the scope of any audit, it is important to recognize which operating system an organization uses. Your audit at minimum should include compliance with maintenance and software update requirements to help ensure the integrity of the infrastructure.
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Excerpted from Electronic Health Recordsby Rebecca S. Busch Copyright © 2008 by Rebecca S. Busch. Excerpted by permission.
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