Patient record requests can be a significant administrative burden for health care providers. An OCR enforcement initiative and a new federal law give providers more reason to get this process right.  We summarize these rules here.

Since the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule became effective in 2003, it generally required covered entities to provide patients timely access to their medical records. However, continued concerns over the level of patient access to records are driving increased emphasis, heightened enforcement activity, and new laws to ensure individuals have easy access to their health information, including the 21st Century Cures Act.  A critical goal of these efforts is to empower patients to be more in control of decisions regarding their health and well-being. By helping individuals have ready access to their health records, according to OCR, they are better positioned:

to monitor chronic conditions, adhere to treatment plans, find and fix errors in their health records, track progress in wellness or disease management programs, and directly contribute their information to research.

The “Right to Access” under HIPAA established a floor for patients to access their health records, which could be exceeded by more stringent state laws. In 2019, the OCR commenced its Right of Access Initiative, an enforcement priority to support individuals’ right to timely access to their health records at a reasonable cost. At least one study found providers are struggling to fully comply. Nonetheless, the OCR has announced nearly 20 enforcement actions under its Right of Access Initiative – a full list of enforcement actions is available on the OCR website. Monetary settlements to date have ranged from $3,500 to $200,000. In addition, the OCR resolution agreements require the covered entities to develop a corrective action plans to prevent further violations.

The Cures Act significantly heightens the obligations under HIPAA right to access. Its Interoperability, Information Blocking, and the ONC Health IT Certification Program seeks to minimize the interference with the ability of authorized persons or entities to access, exchange, or use electronic health information – that is, it wants to eliminate impermissible “information blocking.” More specifically, the Cures Act defines information blocking as business, technical, and organizational practices that prevent or materially discourage the access, exchange, or use of EHI when an actor knows, or (for some actors like electronic health record vendors) should know, that these practices are likely to interfere with access, exchange, or use of EHI.  The law empowers the HHS Office of Inspector General (OIG) to investigate claims of information blocking and to provide referral processes to facilitate coordination with the OCR. The goal of these provisions is to support seamless, secure access, exchange, and use of electronic health information (EHI).

During the nearly 20 years since the HIPAA Privacy Rule became effective, technological changes now support even greater access rights, including enabling access in real time and on demand. Providers, even certain providers not subject to HIPAA, will need to ensure they have compliant policies and procedures for ensuring patients have access to their records and avoiding enforcement actions, headaches, and penalties.

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Photo of Joseph J. Lazzarotti Joseph J. Lazzarotti

Joseph J. Lazzarotti is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. He founded and currently leads the firm’s Privacy, e-Communication and Data Security Practice, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with…

Joseph J. Lazzarotti is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. He founded and currently leads the firm’s Privacy, e-Communication and Data Security Practice, 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, Mr. Lazzarotti 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 – Mr. Lazzarotti 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 – Mr. Lazzarotti’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.

Mr. Lazzarotti 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.

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