This month, security provisions implementing the Health Insurance Portability and Accountability Act (HIPAA) take effect. They are only the latest in a series of implementing provisions, all of which raise complicated legal issues that companies must understand if they are to avoid liability for noncompliance. These issues include how to know when security measures are sufficient under the risk analysis and risk management sections of the regulation and how to respond when law enforcement demands patient information that the privacy regulation protects.
Sufficient security. Under the final security regulation, a company covered by HIPAA must ensure the confidentiality, integrity, and availability of all electronic protected health information that it creates, receives, maintains, or transmits. The regulations do not make a distinction among types of information--such as between routine appointment schedules and drug-screening results, for example. For all types of electronic information, companies are charged with protecting against any unauthorized disclosures or other reasonable threats or hazards to the security or integrity of such information.
HIPAA does not require companies to absolutely protect against every risk. Further, the security regulation allows companies to choose cost-effective security measures by balancing their costs against the losses expected if such measures were not in place.
Risk assessment. The first step toward compliance is a risk assessment. The regulations require that companies perform a proper risk analysis to identify the potential risks to the confidentiality, integrity, and availability of the electronic protected health information they control.
After risks and threats are identified, the question becomes how to take steps legally sufficient to protect against these "reasonably anticipated" threats, hazards, and improper uses or disclosures.
Reasonable steps. Each organization must determine for its unique set of circumstances what specific steps would be reasonable and appropriate. These measures must be documented and kept current.
The rule offers possible solutions, called "addressable specifications." They include specific technologies, such as encryption, or specific procedures, such as access control. The statute notes that if implementing the addressable security measure is not reasonable, the company must document why implementing the measure recommended in the HIPAA regulation would not be reasonable or appropriate and then implement an equivalent alternative measure or explain why nothing is needed.
In other words, an addressable specification can result in one of three actions by the company: implementing the specification, implementing a substitute security measure, or not implementing any security measure because none is necessary. However, each action must be backed by documentation explaining why that course was selected.
For example, the transmission security standard requires companies to make sure that sensitive information that a patient might not want revealed is given extra protection. The standard does not specify any particular remedy. For example, the standard does not mandate that a company use encryption in a specific circumstance, though it lists encryption as one possibility.
A company transmitting electronic health information consisting of AIDS test results over the Internet should find, after a thorough risk analysis, that encryption is reasonable and appropriate under the transmission security standard. Another company transmitting appointment reminders for non-celebrity podiatry patients may find that encryption is not necessary.
Security does not have to adopt every possible security measure to protect against every imaginable harm. Rather, the company should devote its resources to protecting primarily against risks that carry a high probability of occurring and that would cause a high degree of damage if they did occur. …