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So, you’re a HIPAA covered entity or business associate who is in the final throes of revamping (or creating) appropriate and compliant HIPAA privacy and security policies. And, you finally think you are getting a handle on all the changes required by the new HITECH components of the HIPAA rules. And, boy, it’s been some work. So, you’re good for a while, right?

Not really. While the HIPAA privacy and security rules occupy the primary attention for healthcare entities and their business associates, there is a wide range of other privacy and security practices, rules, laws and regulations that must be met—and the laundry list is evolving almost constantly. It’s taken so long for the HITECH rules to become final that we’ve seen a whole new set of issues arise across the healthcare industry, resulting in a set of new challenges that must be addressed at the same time—and continuing beyond September’s HIPAA compliance date—for the healthcare industry and their service providers.

Making sure that your security program works well is the single most important HIPAA compliance step you can take.

Obviously, getting the final touches on an appropriate HIPAA program is important. For most companies, finalizing HIPAA security steps will be the most important obligation. For business associates, this is the first time that HIPAA security compliance is required. For covered entities, compliance has been required for many years, but it seems like some healthcare companies are just realizing the complexity of the HIPAA Security Rule. Making sure that your security program works well is the single most important HIPAA compliance step you can take. In addition, it’s critical to understand the new breach notification rule, the changes to the sale and marketing provisions and the limited new individual rights. Also, new privacy notices and business associate agreements need to be implemented.

Ok, what else is going on in the industry? Remember healthcare reform?

For the past few years (and continuing for several years ahead), we’ve seen a barrage of new healthcare reform programs as a result of the broad-based healthcare reform legislation. Each of these programs has its own set of program requirements, creating substantial compliance obligations across various aspects and components of the healthcare industry. But, for some mostly unexplained reasons, the Department of Health and Human Services (HHS), primarily through its Center for Medicare and Medicaid Services (CMS), seems intent on implementing privacy and security requirements for these programs that are different from the existing HIPAA requirements. Virtually every new healthcare reform program has implemented either a “HIPAA-plus” requirement or a “different than HIPAA” approach. All this does is create challenges without necessarily improving privacy and security. In fact, a strong argument can be made that requiring new time, resources and effort at evaluating different requirements, particularly on security, simply detracts from developing appropriate security programs.

This will be a particular challenge for the health insurance exchange programs, where the privacy and security requirements are substantially different from the existing HIPAA rules, and are still being developed despite an October 1 start date for the program. Some of the privacy and security elements are being left to the individual state exchange programs, which can create their own requirements based on various topic headings mandated by the federal rules. Remember—setting these principles is CMS, a separate department within HHS, which happens to be the same agency that includes the Office for Civil Rights that develops and enforces the HIPAA rules.

At the same time, the HHS Office of the National Coordinator for Health Information Technology (ONC), yet another HHS department, is also developing new and different rules related to health information exchange. Health information exchange programs are designed to improve the flow of information between and among providers and insurers, to improve efficiency, medical effectiveness and the overall quality and cost of healthcare. Sounds pretty much like the “treatment, payment and healthcare operations” purposes that are core to the HIPAA principles. Yet, ONC seems determined to implement a “more than HIPAA” approach across these information exchanges.

And, while healthcare reform is notable for its “different than HIPAA” approach because it is all one agency, other agencies and regulators are getting into the healthcare privacy and security business as well. To some extent, this is because HIPAA itself is too limited in what it applies to; it is not an overall medical privacy rule but is instead a rule that protects certain information when it is held by certain kinds of entities. In the years since the HIPAA statute was passed in 1996, we’ve seen an explosion in avenues for the flow of healthcare information. Some are within the normal scope of the HIPAA regime. Other programs, like healthcare reform, should be within the scope of HIPAA, but the government is taking a different approach. (Apparently, what’s good enough for most of the healthcare system isn’t good enough for these new reform programs).

Regulation of mobile applications is a key focus of FTC activity right now. How much this will impact healthcare companies remains somewhat unclear.

But, it’s clear that there are lots of new avenues for the flow of healthcare information that are not within the scope of HIPAA. The broad range of websites that provide information and education on healthcare issues typically aren’t regulated by HIPAA, because these websites typically are not operated by healthcare providers or health plans. There also are a wide range of new healthcare applications, whether on the now traditional Internet or new mobile applications, which are outside the scope of HIPAA in most circumstances if they are “direct-to-consumer” products.

So, because of these gaps, and the overall explosion in mobile technology, the Federal Trade Commission (FTC) is also getting into the healthcare act. Regulation of mobile applications is a key focus of FTC activity right now. How much this will impact healthcare companies remains somewhat unclear, as healthcare may or may not get wrapped into a broader set of mobile privacy principles. Also, the FTC was given certain enforcement rights related to security breaches involving certain kinds of personal health records, in yet another attempt to close some of the obvious gaps left by the HIPAA structure.

And this is before we even start on the regulation of security practices. We are seeing state breach notification laws, a limited number of state information security practices and now the development of an entire program built around “cybersecurity,” which is—at least partially—data security with a different title. At a minimum, healthcare entities need to keep abreast of this constantly changing security environment, even if HIPAA remains the cornerstone of an effective information security compliance program for the healthcare industry.

So, with the healthcare industry in a continuing state of evolution and turmoil, the consistent pressure to upgrade security practices remains a major challenge. At the same time, the healthcare system also is striving toward a new model where patient engagement is more extensive, which creates its own vicious cycle of security concerns. That means that being smart about security practices, creative about communications models and effective at overall controls will be ever more important in a highly competitive and challenging healthcare industry.


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  • comment K Royal • Sep 4, 2013
    Kirk,  as always, your insight is very helpful. I cannot count the times I hear coworkers and professional colleagues declare that HIPAA is the only standard to meet. People forget about state laws (whether healthcare-specific or not) and federal laws. We live in a regulatory world that is radically evolving. It's a great field to be in and I am curious what we are going to look like in 5 years - 10 years...
  • comment Flora Preston • Mar 24, 2014
    This is a great article - well written and to the point