“... time is lost, confusion results, and money is spent...”
This quote, expressed in 1917 by a Connecticut manufacturing manager, referred to the telephone. Imagine his thoughts now, when a company such as Walmart alone handles more than 1 million customer transactions electronically every hour.1
Today, the amount of data flowing through every technical medium is enormous. Health care information alone is voluminous, and numerous providers, federal and state governments, cooperative groups, physicians, laboratories, hospitals, data companies, and pharmacies see a lot of it.
No one is invisible when it comes to health care data; patients, physicians, hospitals, and pharmacies all generate a trail of data footprints that are gathered and analyzed by someone every day. This volume of data is expected to grow exponentially in the coming years. The streamlining and unification of billing forms, e-prescribing, electronic medical records, and practice management systems used for scheduling and billing will all amplify this growth.
Health care technology has the goal of improving safety through better diagnostic, treatment, and management techniques for all participants in the health care continuum. To meet this goal, rules governing privacy had to be amended to secure personal information. The federal government responded in 1996 with the Health Insurance Portability and Accountability Act (HIPAA). HIPAA was created to protect patients, providers, and clearinghouses that process medical data and integrate billing standards. HIPAA provides oversight of all personal health information. The federal government furthered that initiative with the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.
HIPAA also required that all medical insurance forms be universal. The HCFA 1500 form is used by all insurance companies across the United States to process medical insurance claims. Contained within the HCFA 1500 form are details regarding the physician, International classification of diseases–ninth revision (ICD-9) diagnosis codes, current procedural terminology (CPT) codes, and Healthcare Common Procedure Coding System (HCPCS) codes. These forms also contain National Provider Identifier (NPI) information, which allows all of this information to be tied back to the rendering physician, hospital, and pharmacy. The amount of health care data has grown exponentially since the enactment of HIPAA.
As technology improves, so does the need for protecting health information. Some providers, physicians, patients, and pharmacies may be tacitly aware that their data are “out there,” but few recognize how often the data are analyzed and for what purposes. Safety, clinical trial development, and costs are often the main objectives of data analysis. These data also have allowed physicians to be located who are associated with a large volume of certain patient types, and thereby to be identified as “key opinion leaders.” These thought leaders often influence how standards of care are established and change over time with the dissemination and facilitation of new and emerging information.
Additionally, the FDA Amendments Act of 2007 (FDAAA) gave the FDA authority to require a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs with a high risk potential. As part of these new provisions, ongoing postmarketing safety data for numerous products with a REMS program must be collected. Currently, more than 150 medications are associated with a REMS program, including everything from asthma therapies to narcotics. Executing a REMS program requires a lot of data on both patients and providers. However, most companies with a drug requiring a REMS program are not able to “see” their data because the data are proprietary to the FDA.
REMS programs serve as a registry of patients, physicians, hospitals, and pharmacies dispensing a REMS-required product. Figure 1 lists a blinded example of a product currently requiring a REMS program. As depicted, patient numbers have been decreasing over time because of newer restrictions on its therapeutic use.