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A “Reasonable” Approach to HIPAA Risk Analysis

The Office of Civil Rights (OCR) is responsible for issuing annual guidance on the provisions in the HIPAA Security Rule (45 C.F.R. §§ 164.302 – 318.). But with so much recent interest in IT security driven by the “meaningful use” incentive program, we want to share some our observations and perspectives from recent Redspin client engagements in the healthcare industry.

All electronic protected health information (ePHI) created, received, maintained or transmitted by an organization is subject to the Security Rule. The importance of safeguarding ePHI cannot be understated. Sure, publicized breach notifications and million dollar penalties damage a healthcare organization’s reputation and bottom line. But more than that, such incidents undermine professional and public trust of electronic health records (EHR). And make no mistake about it – the widespread adoption of EHR is fundamental to future improvements in efficiency, communications and patient care.

So if security is the cornerstone to health IT transformation, what can your organization do to not only comply with the regulations but also contribute to this important mission? First, all heathcare organizations are required to evaluate risks and vulnerabilities in their environments. Then they must “implement reasonable and appropriate security measures to protect against reasonably anticipated threats or hazards to the security or integrity of e-PHI.” While “reasonability” is a quintessential element of modern judicial systems, it doesn’t provide a lot of guidance. At Redspin, we suspect there will be little sympathy for major ePHI security breaches no matter what any standard of reasonability might dictate. More simply put, it’s better to be safe than sorry.

Conducting a risk analysis that maps to the HIPAA Security Rule is the first step in protecting ePHI. Note, the Department of Health and Human Services (HHS) does not endorse or recommend any particular risk analysis or risk management model. At Redspin, we think this is wise. From our direct experience, no template or “one-size-fits-all” approach can meet the diverse needs of the healthcare industry. We treat each client individually and conduct a thorough review of their environment even before drafting a scope of work, including:

– size and complexity of the IT environment

– number of physical and logical locations where ePHI is stored

– number of IT staff; their knowledge and experience level

– types of EHR, CPOE and other new applications

– functional responsibilities of team members

– progress-to-date toward EHR completion

– company culture and information security awareness

While a HIPAA Risk Analysis is often project-based, we also consider it the start of a process that will lead to ongoing and durable improvements in information security. The Security Rule itself requires an entity to update and document its security measures “as needed” and specifically recommends conducting continuous risk analysis to identify when such updates are warranted. While the rule does not specify how frequently to do this, it’s a moot point for Redspin’s enterprise security assurance clients. By providing our services on a monthly or quarterly subscription basis, regularly-scheduled assessments, validation and re-testing simply become part of an overall operating environment. Our enterprise solution also tracks and documents all historical findings and remediation via our secure, online web portal. The portal’s dashboard view displays summary information via a compelling graphical user interface, making complex data easier to understand and better enabling you to communicate improvements in your overall security posture to all stakeholders.

In summary, Redspin empowers healthcare organizations to truly integrate their risk analysis and management process. This helps them to accommodate: (1) new technologies (2) evolving business operations, (3) new regulations and (4) personnel changes. And by addressing security risks in a proactive, timely manner rather than fixing problems after implementation, healthcare organizations gain greater value from their investment in IT. Sound reasonable?

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