In a report issued earlier this week, the Office of Inspector General found that the Center for Medicare and Medicaid Services’ (CMS) oversight and enforcement actions were not sufficient to ensure that covered entities, such as hospitals, effectively implemented the HIPAA Security Rule.

OIG’s recommendation: Continue the compliance review process (audits) that began in 2009 and implement procedures for conducting compliance reviews to ensure that HIPAA Security Rule controls are in place and operating as intended to protect ePHI at covered entities.

To reach this conclusion, OIG audited 7 hospitals throughout the country (locations in California, Georgia, Illinois, Massachusetts, Missouri, New York, and Texas).  These audits focused primarily on:

  1. wireless electronic communications network or security measures the security management staff implemented in its computerized information systems (technical safeguards);
  2. the physical access to electronic information systems and the facilities in which they are housed (physical safeguards); and
  3. the policies and procedures developed and implemented for the security measures to protect the confidentiality, integrity, and availability of ePHI (administrative safeguards).

Significant vulnerabilities identified. The audits identified 151 vulnerabilities in the systems and controls intended to protect ePHI, of which 124 were categorized as high impact. A high vulnerability refers to one that

may result in the highly costly loss of major tangible assets or resources; may significantly violate, harm, or impede an organization’s mission, reputation, or interest; or may result in human death or serious injury.

The report noted that outsiders or employees at some hospitals could have accessed, and at one hospital did access, systems and beneficiaries’ personal data and performed unauthorized acts without the hospitals’ knowledge. Although each of the seven hospitals had implemented some controls, policies, and procedures to protect ePHI from improper alteration or destruction, none had sufficiently implemented the administrative, technical, and physical safeguard provisions of the Security Rule. Clearly, mediocre compliance is not sufficient.  

Some of the more significant vulnerabilities found related to (i) wireless access; (ii) access controls, and (iii) integrity controls. In the case of wireless access problems, the report identified vulnerabilities including ineffective encryption, rogue wireless access points, no firewall separating wireless from internal wired networks, the inability to detect rogue devices intruding on the wireless network, and no procedures for continuously monitoring the wireless networks. Access control problems included inadequate password settings, computers that did not log users off after periods of inactivity, unencrypted laptops containing ePHI, and excessive access to root folders. According to the OIG, these conditions could have led to unauthorized individuals viewing or altering ePHI data on nonclinical workstations that were not automatically logged off after a period of inactivity; ePHI being compromised on lost or stolen unencrypted laptops; and unauthorized users circumventing system controls and harming system files.

The list goes on and on.

The Office of Civil Rights (OCR), the arm of HHS now charged with enforcing the HIPAA security regulations, may be listening. As reported here earlier, OCR appears to be taking steps to improve its enforcement efforts, which likely will include increasing the number of compliance reviews/audits at hospitals and health care providers around the country. These efforts include a request by the agency to increase its budget for 2012 by $5.6 million, or 13.6%, to be aimed at enforcement. 

Because HIPAA now applies to business associates, it would not be surprising to see business associates on an audit list. Accordingly, covered entities and business associates should be taking steps now to ensure compliance.

Email this postTweet this postLike this postShare this post on LinkedIn
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.