The development, observance, and enforcement of HIPAA guidelines and procedures is the foundation of HIPAA compliance. If there are no policies and procedures to give instructions, employees of Covered Entities and Business Associates are going to be uninformed of how they ought to perform their tasks that comply with HIPAA, how they ought to respond whenever particular events happen, and what sanctions might be applicable for non-compliance with HIPAA.
The necessity to develop, observe, and enforce HIPAA guidelines and procedures is the initial standard of the Administrative Requirements of the Privacy Rule (45 CFR § 164.530). The standard says a Covered Entity ought to assign a privacy officer who is in charge of the development and execution of the guidelines and procedures of the entity.
This standard is not just applicable to the development and enforcement of Privacy Rule guidelines and procedures, it is likewise applicable to the Breach Notification Rule guidelines and procedures. The assigned privacy officer is additionally in charge of training employees of the Covered Entity about pertinent policies and procedures, and the applicable sanctions for failing to comply.
Concerning the Security Rule guidelines and procedures, the specifications of the Administrative Safeguards (45 CFR § 164.308) are far more extensive. Covered Entities and Business Associates must assign a security officer who is in charge of creating and implementing HIPAA guidelines and procedures made to avoid, find, manage, and correct security breaches.
Even though the Administrative Safeguards of the Security Rule call for general protection and awareness training instead of particular policy and procedure training, security officers are directed to provide documentation to the individuals in charge of carrying out the procedures to which the documentation relates, evaluate compliance, and implement sanctions for failing to comply.
Even though there are countless Covered Entities and Business Associates, the HIPAA policies and procedures do not fit all. The reason being HIPAA benefits various types of organizations and what may be right for a big medical system is probably not right for a technology provider, dental clinic, or veterans´ health program.
Therefore, Covered Entities must perform regular HIPAA risk assessments to determine where there are risks to the integrity, availability, and confidentiality of PHI and create, execute risk analyses to determine gaps, and employ HIPAA guidelines and procedures to minimize risks and vulnerabilities to a sensible and proper level.
To help Covered Entities and Business Associates with the improvement of guidelines and procedures, the HHS´ Office for Civil Rights has launched an interactive Security Risk Assessment Tool that helps users undergo a Security Rule analysis. Nonetheless, this tool doesn’t guarantee HIPAA compliance since it doesn’t cover the Privacy Rule and Breach Notification examination.
Privacy Rule and Breach Notification reviews will need to be performed manually to adhere to the Administrative Requirements of the Privacy Rule – such as reasonably prevent any intentional or unintentional usage or disclosure of Protected Health Information (PHI), which violates the standards, implementation specs, or other demands of this subpart.
HIPAA Policies and Procedures Can’t Be Avoided
The inability to create, implement, and impose HIPAA policies and procedures could have substantial outcomes. Insufficient guidelines result in several HIPAA violations. Not developing, implementing, and imposing HIPAA guidelines and procedures in itself violates HIPAA for which the HHS´ Office for Civil Rights has issued financial penalties in the past.
It is likewise essential to notify everybody about any policies and procedures changes that impact them. What this might mean is the need to revise Notices of Privacy Practices, to train employees again, or to re-issue Business Associate Agreements. All policy alterations ought to be recorded and kept for at least six years.
Besides regularly going over and updating guidelines and procedures in reply to environmental and organizational adjustments, Covered Entities and Business Associates should likewise update policies and procedures in accordance with state regulations. A number of state laws like Texas´ Medical Records Privacy Act go further than state boundaries to any Covered Entity that gathers, maintains, or processes the PHI of a resident in Texas irrespective of where the Covered Entity is situated.
Another reason for updating HIPAA policies and procedures is that if new HIPAA regulations are released, it will be less difficult for Covered Entities and Business Associates to evaluate and change current policies and procedures. This does not just mitigate the administrative cost of HIPAA compliance, it will additionally simplify the release of adjustments for patients, employees, and Business Associates.