Disclosing protected health information (PHI) to a business associate without a compliant business associate agreement (BAA) is an improper disclosure under the HIPAA privacy and security regulations. According to the HHS Office for Civil Rights (OCR), an error like that can cost a small healthcare provider $31,000.

OCR recently announced a resolution agreement (pdf) with the Center for Children’s Digestive Health, S.C. (CCDH), a “small, for-profit health care provider with a pediatric subspecialty practice that operates its practice in seven clinic locations in Illinois.” According to the resolution agreement, OCR apparently learned of the missing BAA while investigating CCDH’s file storage vendor, FileFax, Inc., which stored CCDH’s PHI. Responsible for enforcing the privacy and security rules under HIPAA, OCR then commenced a compliance review of CCDH. It reported finding that neither CCDH nor FileFax could produce a signed BAA applicable to periods that CCDH had shared PHI with FileFax.  Without an admission of liability, CCDH agreed to resolve the matter by paying $31,000 and agreeing to comply with a comprehensive Corrective Action Plan (CAP).

The Health Information Technology for Economic and Clinical Health (HITECH) Act made a number of changes to HIPAA, including to the rules concerning “business associates.” Among those changes were updates to BAAs that the HIPAA rules require covered entities to maintain with their business associates. A covered entity’s business associates include third-party service providers, such as: claims administrators, accounting firms, law firms, consultants, cloud and other data storage providers.

The regulations make clear that even though business associates are directly subject to many of the HIPAA privacy and security requirements, BAAs remain necessary for compliance. A starting point for BAA compliance is the set of sample provisions posted by the OCR. However, there are other issues that parties to a BAA will want to address, such as: specificity concerning the safeguards that should be in place, data breach coordination and response, indemnity, cybersecurity insurance, and agency status. More information about business associates and BAAs can be accessed here.

Covered entities also should remember that the HIPAA regulations are not the only rules that require written assurances from third-party service providers concerning security of personal information. A number of state laws (e.g., California, Massachusetts, Maryland, New Mexico, New York, Oregon) require businesses to have contracts with third-party service providers to safeguard personal information. Of course, even in the absence of a federal or state law, taking steps to ensure vendors secure the confidential information they are provided, such as through a detailed data security agreement, is a prudent practice.

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Photo of Joseph J. Lazzarotti Joseph J. Lazzarotti

Joseph J. Lazzarotti is a principal in the Berkeley Heights, New Jersey, office of Jackson Lewis P.C. He founded and currently co-leads the firm’s Privacy, Data and Cybersecurity practice group, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP)…

Joseph J. Lazzarotti is a principal in the Berkeley Heights, New Jersey, office of Jackson Lewis P.C. He founded and currently co-leads the firm’s Privacy, Data and Cybersecurity practice group, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with the International Association of Privacy Professionals. Trained as an employee benefits lawyer, focused on compliance, Joe also is a member of the firm’s Employee Benefits practice group.

In short, his practice focuses on the matrix of laws governing the privacy, security, and management of data, as well as the impact and regulation of social media. He also counsels companies on compliance, fiduciary, taxation, and administrative matters with respect to employee benefit plans.

Privacy and cybersecurity experience – Joe counsels multinational, national and regional companies in all industries on the broad array of laws, regulations, best practices, and preventive safeguards. The following are examples of areas of focus in his practice:

  • Advising health care providers, business associates, and group health plan sponsors concerning HIPAA/HITECH compliance, including risk assessments, policies and procedures, incident response plan development, vendor assessment and management programs, and training.
  • Coached hundreds of companies through the investigation, remediation, notification, and overall response to data breaches of all kinds – PHI, PII, payment card, etc.
  • Helping organizations address questions about the application, implementation, and overall compliance with European Union’s General Data Protection Regulation (GDPR) and, in particular, its implications in the U.S., together with preparing for the California Consumer Privacy Act.
  • Working with organizations to develop and implement video, audio, and data-driven monitoring and surveillance programs. For instance, in the transportation and related industries, Joe has worked with numerous clients on fleet management programs involving the use of telematics, dash-cams, event data recorders (EDR), and related technologies. He also has advised many clients in the use of biometrics including with regard to consent, data security, and retention issues under BIPA and other laws.
  • Assisting clients with growing state data security mandates to safeguard personal information, including steering clients through detailed risk assessments and converting those assessments into practical “best practice” risk management solutions, including written information security programs (WISPs). Related work includes compliance advice concerning FTC Act, Regulation S-P, GLBA, and New York Reg. 500.
  • Advising clients about best practices for electronic communications, including in social media, as well as when communicating under a “bring your own device” (BYOD) or “company owned personally enabled device” (COPE) environment.
  • Conducting various levels of privacy and data security training for executives and employees
  • Supports organizations through mergers, acquisitions, and reorganizations with regard to the handling of employee and customer data, and the safeguarding of that data during the transaction.
  • Representing organizations in matters involving inquiries into privacy and data security compliance before federal and state agencies including the HHS Office of Civil Rights, Federal Trade Commission, and various state Attorneys General.

Benefits counseling experience – Joe’s work in the benefits counseling area covers many areas of employee benefits law. Below are some examples of that work:

  • As part of the Firm’s Health Care Reform Team, he advises employers and plan sponsors regarding the establishment, administration and operation of fully insured and self-funded health and welfare plans to comply with ERISA, IRC, ACA/PPACA, HIPAA, COBRA, ADA, GINA, and other related laws.
  • Guiding clients through the selection of plan service providers, along with negotiating service agreements with vendors to address plan compliance and operations, while leveraging data security experience to ensure plan data is safeguarded.
  • Counsels plan sponsors on day-to-day compliance and administrative issues affecting plans.
  • Assists in the design and drafting of benefit plan documents, including severance and fringe benefit plans.
  • Advises plan sponsors concerning employee benefit plan operation, administration and correcting errors in operation.

Joe speaks and writes regularly on current employee benefits and data privacy and cybersecurity topics and his work has been published in leading business and legal journals and media outlets, such as The Washington Post, Inside Counsel, Bloomberg, The National Law Journal, Financial Times, Business Insurance, HR Magazine and NPR, as well as the ABA Journal, The American Lawyer, Law360, Bender’s Labor and Employment Bulletin, the Australian Privacy Law Bulletin and the Privacy, and Data Security Law Journal.

Joe served as a judicial law clerk for the Honorable Laura Denvir Stith on the Missouri Court of Appeals.