Mobile health (“mHealth”) medical app developers, including health information technology (“HIT”) and telemedicine app developers, tend to focus on FDA requirements. Indeed since many of these apps may be categorized as medical devices, and the FDA approval process is lengthy, developers are wise to focus on whether an app is regulated by the FDA. But a successful developer should also build privacy protections (e.g., privacy policies) and security protections (e.g., disaster recovery) into its product from the earliest stages. The Federal Trade Commission (“FTC”) calls this “Privacy By Design.” “Security By Design” is the corollary. Continue reading Attention mHealth, HIT and Telemedicine App Developers: Privacy and Security By Design Is Critical
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.
One of the most significant changes in the final HIPAA amendments is the Breach Notification Rule, which modifies and clarifies the definition of “breach” and the risk-assessment approach required for breach notification. In light of this heightened standard, covered entities, business associates and downstream contractors should consider carefully reviewing their breach notification policies and procedures, training materials and contractual arrangements in an effort to avoid potential liability under the Breach Notification Rule.
Click here for more information on the most significant changes to the Breach Notification Rule.
Among the most significant changes of the Final HIPAA amendments are the provisions that extend the Privacy and Security Rules’ stringent compliance obligations to business associates (BA) and expand the definition of BAs to include subcontractors of BAs. Why the changes? The HITECH Act of 2009 specifically extends direct liability to BAs and expands the list of obligations for BAs. The Department of Health & Human Services extends BA obligations even further to ensure the privacy and security of all PHI throughout the HIPAA ecosystem.
Click here to read a summary of the key provisions under the 2013 amendments, as well as factors that may be worthwhile for covered entities and business associates to consider in light of these amendments.