The 2013 HIPAA Amendments directly apply to healthcare providers, plans and clearinghouses as “covered entities,” as well as their subcontractors and vendors as “business associates” (including their downstream subcontractors and agents). However, it is not just covered entities and business associates that need to understand the 2013 Amendments. Advertisers, data aggregators, market researchers and others that want access to PHI, even data that appear to be de-identified, will be impacted.
HIPAA-covered entities and many of their vendors—among them are HIO and EHR consultants, data analytic firms, data transmission facilitators, software vendors and device vendors—rely on health information technology (HIT) to accomplish their purposes. Large data companies, small entrepreneurs and investors are participating in the growth of HIT.
Because HIPAA includes employer-sponsored group health plans under the definition of insurers, employers that sponsor plans are also affected by the GINA amendments to the HIPAA Privacy Rule (“the GINA amendments”). In addition, the GINA amendments will have applicability beyond the insurance industry because they draw distinctions between permissible and impermissible uses of “genetic information” in connection with the diagnosis of a medical condition. Click here to read more about how the new HIPAA rules regarding genetic information affect employers, group health plans, health insurers and healthcare providers.
Employers that sponsor group health plans for their employees should pay careful attention to the newly announced final omnibus rule amending HIPAA in accordance with the HITECH Act of 2009. This final rule under the HITECH Act, issued on January 17, 2013, impacts group health plans in two significant ways. Group health plan sponsors should act now to make changes to existing plan documents, including HIPAA procedures and business associate agreements, in response to the Final Rule.
Click here for an overview of how HIPAA generally applies in the context of employer-sponsored group health plans and these significant changes impacting group health plans.
The HIPAA Rules require that when a HIPAA-covered entity (a provider, plan or clearinghouse) or a business associate of a covered entity uses or discloses protected health information (“PHI”), or when it requests PHI from another covered entity or business associate, the covered entity or business associate must make “reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.”
Click here to read more about the HIPAA “minimum necessary” standard—one of the most essential, yet vague, aspects of the HIPAA Rules.
The 2013 Amendments include a number of sweeping changes to the HIPAA Rules, including the expansion of the definition of a business associate to include their subcontractors that handle protected health information (“PHI”); a lower threshold for determining whether a breach has occurred for reporting purposes; and restrictions on “marketing” activities and the “sale” of PHI.
Click here to read this Overview Summary of the 2013 Amendments. Duane Morris is issuing a series of Alerts on the 2013 Amendments. Please see the in-depth Alerts already distributed by the firm on changes under the 2013 Amendments to the definition of a business associate and changes to the breach notification requirements. We will continue to issue Alerts on discrete HIPAA topics.