Today's healthcare organizations are being urged to adopt electronic health records in the midst of complex legal and regulatory changes, especially in the areas of privacy and security. In this environment there is a clear need for a security framework specifically designed to help healthcare organizations build a security program that addresses all current data protection requirements.
For years, there has been considerable opinion in the healthcare industry that HIPAA does not adequately protect health data in today's rapidly changing IT environment.
The HIPAA security rule itself does not prescribe specific security controls. Instead it requires ongoing risk assessment as a basis for an organization's selection and maintenance of security controls. This inherent flexibility, both a benefit and a compliance challenge, has perhaps inhibited the ability of HHS to determine and enforce compliance and provide meaningful guidance, education and support to the industry.
The advent of ARRA has brought long overdue additional statutory requirements for "covered entities" as well as an extension of HIPAA to other entities. ARRA has additional requirements such as: breach notification, accounting of disclosures, new limits on the sale and marketing of personal health information, a right to restrict disclosures and increased enforcement.
There is general agreement that these new requirements will enhance health data protection. HHS will undertake rulemaking on these requirements in the near term, which is expected to produce greater specificity in individual standards.
However, greater specificity without the benefit of context within an appropriate security program framework still does not meet the needs of the industry.
There are many security frameworks and/or framework components in existence. But none individually meet the particular needs of healthcare organizations, nor do they clearly relate to an organization's business and strategic goals. A healthcare security framework developed and maintained by healthcare industry stakeholders is the best way to meet the needs of healthcare organizations.
This framework should include:
• A structure to which an organization can relate its security program that is independent of technology and technology platform.
• A description of common elements that an organization should have in its security program, implemented differently depending on compliance and risk requirements.
• A mechanism for mapping and assessing against current compliance requirements.
• A scalable model capable of integrating new or emerging requirements.
• Guidance resource for selection and implementation of appropriate security controls and processes.
• A means to determine effectiveness and compliance against measurable industry best practices.
HIPAA, like other data protection requirements, defines the categories of controls needed to assure protection of electronic personal health information, but it does not provide an information security framework. HIPAA assumes the implementation of controls within a common security framework—an assumption that has not come to fruition.
Facing an increasingly complex and costly security environment, today's healthcare organizations need nothing less than is already provided to other regulated industries with serious data protection requirements. They must have the tools and resources they need to implement a sound security program and meaningfully demonstrate compliance. It is time to address this disparity in healthcare data protection.