What is the state of the HITECH enforcement regime?
We are certain that all of our readers will be happy to hear that HITECH's enforcement regime is alive and well, thank you very much. We don't enjoy (per se) being the bearer of "bad news" but here's a news flash: Privacy and Security regarding PHI will remain of paramount importance going forward!
There is simply NO WAY that either the Federal Government (read HHS and the FTC), and the tech giants who are "ramping up to seize the moment" can tolerate anything less than the security standard set by the online banking community: 1) the former because tolerating less is bad public policy; and 2) the latter because tolerating less is bad PR (news travels fast on the Internet 24/7 365).
We have yet to see the new sheriff flex her muscles, but rest assured that Doc Holiday and Wyatt Earp will be riding your way any day now. The HITECH sections labeled Improved Enforcement and Audits are a harbinger of things to come. This article does a good job at getting at some of the "willful neglect" issues that will trigger the biggest fines.
OK, here's our "cliff notes" version of what "willful neglect" means in unambiguous English: willful neglect means "clueless." Here are some examples that illustrate our definition:
- Your organization is simply unaware; just dusting off your old HIPAA documentation will no longer suffice (the ONLY reason you believe that you are currently in compliance now is because HIPAA was a paper tiger that was never enforced). In short, you are clueless if the world has changed and you don't know it. It's like missing the invention of the telephone and the Internet.
- You are clueless if you don't have any processes in place to support your policies and procedures. Having well written (and current) policies and procedures in place will not help you much if you can't show that you are following them. The only way to ensure compliance is to have a process in place that enforces it.
- You are clueless if you are a CE that does business with a number of BAs and have no contracts in place with them, or if you are still using your old contracts.
- You are clueless if you are a BA and have no contracts in place with third parties that touch the PHI that has been entrusted to you by a CE.
- You are clueless if, as a CE or BA, you think you can outsource liability by doing business with partners that are not directly subject to U.S. law, and assume therefore, that those partners need not comply (while arguably true you are still on the hook for having contracts with said partners).
OK, here's the bottom line: if you can't show visible demonstrable evidence (over time) ("VDE") that you are in compliance then you are clueless. If you know that you are not in compliance and don't have a plan in place to get into compliance, you are clueless. Forget about all the legal niceties that may distinguish "reasonable cause" from "willful neglect." Without VDE (and a strategic plan) there is not a lawyer on the planet smart enough to help you. You (and your lawyer) will need both VDE and a plan to make a "good faith" argument to a federal agency or a court of law. Period.
We can assure our readers that most of you are not in compliance because, for the most part, you have NOT figured out (yet) what that really means. Remember, whatever you have in place now is probably inadequate. It was never subjected to an audit and therefore never validated. HHS is going to have a field day handing out fines once it figures out its methodology for conducting the audits that are mandated under HITECH.
Your CEO is not likely to be a happy camper if you end up on HHS' publicly available list of organizations that have experienced a breach, especially if said breach was not handled well and/or you were found to be in willful neglect. On the other hand, you are not going to be able to make much process unless the compliance budget supports the initiative(s). We don't have any empirical data but would venture a guess: most compliance budgets are nowhere near sufficient to meet HITECH's requirements today.
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