As she had done in 2014, Marla Durben Hirsch interviewed my partner Elizabeth Litten and me for her annual Medical Practice Compliance Alert article on compliance trends for the New Year. While the article, which was entitled “6 Compliance Trends That Will Affect Physician Practices in 2015,” was published in the January 5, 2015 issue of Medical Practice Compliance Alert, a synopsis of the article can be found here. As we have previously pointed out, we always enjoy our talks with Marla because she never fails to direct our thinking to new areas. We look forward to the opportunity for further encounter sessions with her.
While the article discussed a diverse range of topics affecting physician practices, including accountable care organizations (ACOs) and telemedicine, this blog post will focus on HIPAA-related areas.
Even more HIPAA and related enforcement activities can be expected in 2015.
The article observed that providers will not see a reprieve in this area. Breaches of patient and consumer data continue to proliferate; the tremendous publicity that breaches outside of the HIPAA area have received, such as the hacking of Home Depot and Sony, will create more pressure on HHS’ Office for Civil Rights (OCR) to enforce HIPAA breaches. The article quotes us as saying “It’s [A HIPAA privacy breach is] very personal to people when their health data is filched; it’s creepy.”
The article also quotes Elizabeth, who warns that practices also should expect increased activity by the Federal Trade Commission in the area of healthcare data breaches through its enforcement of consumer protection laws and from the Food and Drug Administration’s protection of the integrity of medical devices, even though those federal agencies do not have the same comprehensive standards and clear regulations that OCR does to enforce HIPAA.
Additionally, there is likely to be more private litigation using HIPAA compliance as the standard of care, even though HIPAA itself does not give patients the right to sue for violations. The November 2014 ruling in the Connecticut Supreme Court discussed on this blog here and here recognized HIPAA’s requirements as a standard of care in a state breach of privacy lawsuit. Elizabeth and I observed that the Connecticut case will spawn copycat lawsuits using HIPAA the same way for state breaches of privacy, negligence and other causes of action.
Covered entities and business associates will refine their agreements, all as they come under more scrutiny.
Many practices and their business associates scrambled to sign business associate agreements (BAAs), often using model forms from OCR and professional societies, to ensure that they had them in place by the September 2013 effective date — and for those who needed only to update an existing BAA, September 2014. However, as discussed in the article, covered entities and business associates now are negotiating the language in BAAs and customizing them to their individual needs, such as choice of law and indemnification requirements.
One provision that may become more prevalent in newer BAAs would allow a business associate that deals with large amounts of data — such as a cloud electronic health records vendor — to use covered entity’s de-identified patient data for the business associates’ own uses. An industry is developing around the aggregation of data for purposes such as research or predicting patient outcomes, and some business associates are moving to capitalize on that data and use it or market it to others. According to Elizabeth, covered entities will need to determine whether they want to grant such business associates permission to use the data that way.
Business Associates Can Expect Audits by OCR in 2015.
The activities of business associates also will be under the microscope. The permanent HIPAA audit program, slated to begin in 2015, is expected to audit business associates as well as covered entities. Elizabeth observed that the use of subcontractors by business associates also will be examined more carefully, especially those who use off-shore subcontractors.
Again, to read more, click here and see the full article in the January 5, 2015 issue of Medical Care Compliance Alert.