The HIPAA/HITECH Omnibus Rule became effective just over one year ago. The compliance date was just over six months ago. Within about another six months (plus or minus), Federal regulators – at the Office for Civil Rights at the US Department of Health and Human Services – will begin a new round of HIPAA compliance audits.

Regulators are already actively involved in complaint investigations governed by the “new” HIPAA rules. Other Federal, state and territorial authorities are actively involved in HIPAA and related health data privacy and security enforcement activity: the Federal Trade Commission, the Secret Service, the Puerto Rico Health Insurance Administration, state attorneys general.

The “Wall of Shame” on the OCR website adds information about newly disclosed data breaches on a regular basis. Fines under the new HIPAA rules may hit $1.5 million or more. Fines under other regulatory schemes have climbed significantly higher. Compliance agreements, follow-up audits and more await those covered entities (healthcare providers or payers) (CEs) or business associates (everyone else in the healthcare ecosystem – billing services, marketing agencies, consultants, shredding contractors, attorneys, accountants, etc.) unfortunate enough to experience a lapse in their HIPAA compliance programs and to have occasion to file a breach notification, or to be the subject of a complaint investigation or random audit.

Long before becoming covered entities under HIPAA, physician practices have been aware of their responsibilities regarding privacy and security of protected health information (PHI in HIPAA-speak). The HIPAA rules have added a layer of compliance requirements to a pre-existing landscape of patient records privacy laws. Some of the regulatory changes affect the ways in which physician practices may market to new and established patients, but many of the changes that took effect last year relate to the obligations of business associates – “downstream contractors” that deal in PHI on behalf of physician practices.

BAs are now explicitly subject to the same compliance requirements applicable to CEs. And it is the responsibility of each CE to ensure that downstream contractors are doing what they are supposed to be doing in the realm of HIPAA compliance – or risk being held liable for the failings of their BAs. It is therefore a good time for physician practices to re-examine their HIPAA compliance plans, the scrutiny applied to their BAs’ HIPAA compliance programs, and their contractual agreements with BAs. The bottom line is, well, the bottom line; covered entities are now explicitly liable for the HIPAA compliance of their business associates.

What does this mean in practice?

1. Tailor-made compliance plans. Unlike other regulatory schemes, which envision compliance with specific rules and regulations, and allow for certification of compliance, HIPAA is a much looser construct. There are standards, but adherence with all of them is not mandatory. Some standards are “addressable” – which means that regulated entities may address certain regulatory concerns in ways other than full compliance with the methods outlined in the rule. The idea is that this is not a one-size-fits-all program; rather, HIPAA compliance programs need to be tailored to the privacy and security needs of an individual CE or BA.

2. Adoption of policies; review of policies and related documents. Privacy and security policies must be revised and updated on a regular basis, particularly in connection with a major regulatory overhaul such as the promulgation of the Omnibus Rule, but also on an annual basis. Grandfathered Business Associate Agreements (BAAs) should be reviewed for compliance with the new regulations as well. More and more CEs are looking for indemnification provisions in their BAAs. In the end, though, the indemnities are only as good as the BA’s HIPAA compliance program and insurance, both of which bear closer examination.

3. Workforce training. Once appropriate policies, agreements and insurance are in place, the workforce must be trained, and tested, on the HIPAA compliance material.

4. Risk assessments. Annual risk assessments – preferably handled by outside data security experts – must be conducted on an annual basis. A good risk assessment will uncover room for improvement even in an organization that is highly attuned to HIPAA compliance. Why? Because this is more of a continuous improvement exercise addressing evolving realities than it is check-the-box compliance with a static rule.

Are there things other than HIPAA compliance that demand investment of staff and other resources? Of course there are. But the costs associated with failing to invest appropriately in this realm can be significant. Multi-million-dollar fines and imposition of compliance monitoring agreements – to say nothing of the attendant negative publicity – may be devastating. It seems clear that the investment in HIPAA compliance is one that is likely to pay dividends over the years.

A well-developed, well-documented and well-implemented privacy and security policy, where training and testing of staff is documented, where key agreements are in place and easily producible for review when your friendly neighborhood government agent comes knocking, will go a long way towards minimizing potential sanctions when (not if) your organization experiences a breach of privacy or security of protected health information.

David Harlow is Principal of The Harlow Group LLC, a health care law and consulting firm based in Boston, MA. He blogs regularly at HealthBlawg, where this post originally appeared. Follow him on Twitter.

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