While your business may indeed be a “victim” when hit by a phishing attack, your enterprise can also be responsible for violations of law associated with the incident.   Earlier this week, the HHS Office for Civil Rights (“OCR”) announced a $400,000 settlement with Metro Community Provider Network (“MCPN”) related to a 2012 HIPAA breach caused by a phishing scam. The phishing scam, carried out by accessing MCPN employees’ email accounts, gave a hacker access to the electronic protected health information (“ePHI”) of 3,200 individuals. In investigating the breach, OCR determined that, prior to the breach, MCPN had not conducted a security risk analysis (a requirement under HIPAA). Further, OCR found that even after MCPN conducted a risk analysis, its analysis was insufficient to meet the requirements of the HIPAA Security Rule.

In addition to the $400,000 fine, MCPN agreed to a corrective action plan with OCR. That plan requires MCPN to conduct a comprehensive risk analysis and to submit a written report on the risk analysis to OCR. Additionally, MCPN will be required to develop an organization-wide risk management plan, to review and revise its Security Rule policies and procedures, to review and revise its Security Rule training materials, and to report to OCR any instance of a workforce member failing to comply with its Security Rule policies and procedures.

The MCPH settlement underscores the importance of risk analyses and workforce training to avoid phishing scams. Additionally, it is crucial that entities regulated by HIPAA conduct an enterprise-wide HIPAA risk analysis, update that analysis to address new threats, and implement policies and training based on identified risks. Failure to comply with these essential HIPAA requirements can turn a relatively routine breach investigation into a $400,000 settlement.

A copy of the MCPN resolution agreement and corrective action plan is available here. OCR’s press release on the settlement is available here. General Security Rule guidance from OCR is available here.

At last week’s Health Care Compliance Association’s annual “Compliance Institute,”  Iliana Peters, HHS Office for Civil Rights’ Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA enforcement trends as well as a road map to OCR’s current and future endeavors.

Continuing Enforcement Issues

Ms. Peters identified key ten enforcement issues that OCR continues to encounter through its enforcement of HIPAA.  Do any of them look familiar to you? These issues include:

  1. Impermissible Disclosures. HIPAA’s Privacy Rule prohibits covered entities and business associates from disclosing PHI except as permitted or required under HIPAA. Impermissible disclosures identified by Ms. Peters all center on the need for authorization, and include:
    • Covered entities permitting news media to film individuals in their facilities prior to obtaining a patient’s authorization.
    • Covered entities publishing PHI on their website or on social media without an individual’s authorization.
    • Covered entities confirming that an individual is a patient and providing other PHI to reporters without an individual’s authorization.
    • Covered entities faxing PHI to an individual’s employer without the individual’s authorization.
  2. Lack of Business Associate Agreements. OCR continues to see covered entities failing to enter into business associate agreements.
  3. Incomplete or Inaccurate Risk Analysis. Under HIPAA’s Security Rule, covered entities are required to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic PHI (ePHI). According to Ms. Peters, organizations frequently underestimate the proliferation of ePHI throughout their environment, including into systems related to billing, faxing, backups, and medical devices, among others.
  4. Failure to manage identified risks. HIPAA requires regulated entities to put in place security measures to reduce risks and vulnerabilities. According to the presentation, several OCR breach investigations found that the causes of reported breaches were risks that had previously been identified in a risk analysis but were never mitigated. In some instances, encryption was included as part of the remediation plan, but was never implemented.
  5. Lack of transmission security. While not required in all cases, HIPAA does require that ePHI be encrypted whenever it is deemed appropriate. The presentation identified a number of applications in which encryption should be considered when transmitting ePHI, including email, texting, application sessions, file transmissions (e.g., FTP), remote backups, and remote access and support services (e.g., VPNs).
  6. Lack of Appropriate Auditing. HIPAA requires the implementation of mechanisms (whether hardware, software or procedural) that record and examine activity in systems containing ePHI. HIPAA-regulated entities are required to review audit records to determine if there should be additional investigation. The presentation highlighted certain activities that could warrant such additional investigation, including: access to PHI during non-business hours or during time off, access to an abnormally high number of records containing PHI, access to PHI of persons for which media interest exists, and access to PHI of employees.
  7. Patching of Software. The use of unpatched or unsupported software on systems which contain ePHI could introduce additional risk into an environment. Ms. Peters also pointed to other systems that should be monitored, including router and firewall firmware, anti-virus and anti-malware software, and multimedia and runtime environments (e.g., Adobe Flash, Java, etc.).
  8. Insider Threats. The presentation identifies insider threats as a continuing enforcement issue. Under HIPAA, organizations must implement policies and procedures to ensure that all members of its workforce have appropriate access to ePHI and to prevent those workforce members who do not have access from obtaining such access. Termination procedures should be put in place to ensure that access to PHI is revoked when a workforce member leaves.
  9. Disposal of PHI. HIPAA requires organizations to implement policies and procedures that ensure proper disposal of PHI. These procedures must guarantee that the media has been cleared, purged or destroyed consistent with NIST Special Publication 800-88: Guidelines for Media Sanitization.
  10. Insufficient Backup and Contingency Planning. Organizations are required to ensure that adequate contingency planning (including data backup and disaster recovery plans) is in place and would be effective when implemented in the event of an actual disaster or emergency situation. Organizations are required to periodically test their plans and revise as necessary.

Upcoming Guidance and FAQs

OCR also identified upcoming guidance and FAQs that it will use to address the following areas:

  • Privacy and security issues related to the Precision Medicine Initiative’s All of Us research program
  • Text messaging
  • Social media
  • Use of Certified EHR Technology (CEHRT) & compliance with HIPAA Security Rule (to be release with the Office of the National Coordinator for Health Information Technology (ONC))
  • The Resolution Agreement and Civil Monetary Penalty process
  • Updates of existing FAQs to account for the Omnibus Rule and other recent developments
  • The “minimum necessary” requirement

Long-term Regulatory Agenda

The presentation also identifies two long-term regulatory goals to implement certain provisions of the HITECH Act. One regulation will relate to providing individuals harmed by HIPAA violations with a percentage of any civil monetary penalties or settlements collected by OCR, while the second will implement a HITECH Act provision related to the accounting of disclosures of PHI.

Audit Program Status

The presentation discussed the current status of OCR’s audit program. As we have previously discussed, OCR is in the process of conducting desk audits of covered entities and business associates. These audits consist of a review of required HIPAA documentation that is submitted to OCR. According to Ms. Peters, OCR has conducted desk audits of 166 covered entities and 43 business associates. Ms. Peters also used the presentation to confirm that on-site audits of both covered entities and business associates will be conducted in 2017 after the desk audits are completed. We will continue to follow and report on developments in the audit program.

Commentary

The list of continuing enforcement issues provides covered entities and business associates with a helpful reminder of the compliance areas that are most likely to get them in compliance trouble. Some of the enforcement issues may require HIPAA-regulated entities to revisit decisions that they previously made as part of a risk analysis. Transmission security (#5, above) is an example of such an area that may warrant reexamination. In the past, encrypting data was often too expensive or too impracticable for many organizations. However the costs of encryption have decreased while it has become easier to implement. A covered entity or business associate that suffers a breach due to transmitting unencrypted PHI over the internet will likely garner little sympathy from OCR going forward. The presentation is also notable for the long list of guidance and FAQs that OCR will be publishing, as well as their plan to issue regulations to address changes ushered in by the HITECH Act that were not captured by the 2013 Omnibus Rule. These regulations, particularly the regulations related to accounting for disclosures of PHI, could have a far-reaching impact on how covered entities and business associates comply with HIPAA in the future.

The FBI has issued new guidance specifically applicable to medical and dental facilities regarding the cybersecurity risk of File Transfer Protocol (“FTP”) servers operating in “anonymous” mode.  FTPs are routinely used to transfer information between network hosts.  As further described in the guidance, when an FTP server can be configured to permit anonymous users (through the use of a common user name like “anonymous” and without the use of a password) to gain access to the information stored on the server, which might include sensitive information about patients.  In addition to potentially directly compromising the security of the stored information, a hacker could use the FTP server in anonymous mode to launch a cyber attack on the entity.

The FBI provides the following specific guidance, which Covered Entities and Business Associates should heed:

The FBI recommends medical and dental healthcare entities request their respective IT services personnel to check networks for FTP servers running in anonymous mode. If businesses have a legitimate use for operating a FTP server in anonymous mode, administrators should ensure sensitive PHI [Protected Health Information] or PII [Personally Identifiable Information] is not stored on the server.

Coupled with recent advice from FBI Director James B. Comey on ransomware, which we blogged about here, this latest guidance from the FBI demonstrates the seriousness the potential cybersecurity threats facing healthcare entities.

Wearable technology continues to do a full court press on the marketplace and in the process, the step counters of the world and health apps tied to devices capable of tracking real-time biostatistics, are revolutionizing the way companies think about wellness. Wearables are the latest in workplace fads and they’ve got the numbers to back it up: sales are likely to hit $4 billion in 2017 and 125 million units are likely to be shipped by 2019. Wearable technology has transformed the workplace just as more and more employers are utilizing wellness programs to improve employee motivation and health.  As the popularity of these technologies soars, so too will concerns around the associated privacy and data security risks.  In this blog post, we discuss just a few of the legal implications for employers who run wellness programs embracing this new fad. Continue Reading March Fadness: Wearable Tech in the Workplace and Privacy

Last week, the HHS Office for Civil Rights (OCR) disclosed a $5.5 million settlement with Memorial Healthcare Systems (MHS) for HIPAA violations affecting the protected health information (PHI) of 115,143 individuals. The Resolution Agreement, which can be found here, also contains a detailed corrective action plan (CAP).

The Florida-based health system reported to OCR that the PHI had been impermissibly accessed by MHS employees and impermissibly disclosed to affiliated physician office staff. The PHI consisted of names, dates of birth, and social security numbers.

According to OCR, the login credentials of a former employee of an affiliated physician’s office had been used to access the ePHI maintained by MHS on a daily basis without detection from April 2011 to April 2012, affecting 80,000 individuals. Although it had workforce access policies and procedures in place, MHS failed to implement procedures with respect to reviewing, modifying and/or terminating users’ right of access, as required by HIPAA. The health system also failed to regularly review records of information system activity for its applications that maintain electronic PHI and which are accessed by workforce users and users at affiliated physician practices. To make matters worse, the health system failed to review the audit information despite having identified this risk on several risk analyses conducted by MHS from 2007 to 2012.

“Access to ePHI must be provided only to authorized users, including affiliated physician office staff” said Robinsue Frohboese, Acting Director, HHS Office for Civil Rights. “Further, organizations must implement audit controls and review audit logs regularly. As this case shows, a lack of access controls and regular review of audit logs helps hackers or malevolent insiders to cover their electronic tracks, making it difficult for covered entities and business associates to not only recover from breaches, but to prevent them before they happen.”

While hacking incidents typically garner more media coverage, this case highlights the increasing threat posed by those inside a HIPAA-regulated organization. According to a Protenus report, nearly 60% of the breaches that occurred this past January involved insiders. Organizations would be well-served by reviewing recent OCR guidance on the importance of audit controls.

Originally posted in Mintz Levin’s Health Law Policy Matters

As published in our sister blog, Health Law & Policy Matters

OCR Provides Additional Clarification on Phishing Scam

As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR’s Phase 2 audit program. The email, which was disguised as an official communication, suggests that recipients click on a link. This link takes recipients to a non-governmental website marketing cybersecurity services.

On Wednesday, OCR followed up their alert with additional details about the phishing campaign. According to OCR, the phishing email originates from the email address OSOCRAudit@hhs-gov.us and directs individuals to a URL at http://www.hhs-gov.us. OCR points out the subtle difference from the official email address for its HIPAA audit program, OSOCRAudit@hhs.gov, noting that such subtlety is typical in phishing scams.

OCR also took the opportunity to confirm that it has notified select business associates of their inclusion in the Phase 2 HIPAA audits.  For more information about the Phase 2 audit program please visit our earlier post.

The term “cloud computing,”  — a process by which remote computers are used to store, manage and process data — is no longer an unfamiliar term. According to at least one estimate, “approximately 90 percent of businesses using the cloud in some fashion.” American Airlines is assessing major providers of cloud services for an eventual relocation of certain portions of its customer website and other applications to the cloud.

What some may not realize is that there are actually three main types of clouds: public, private and hybrid.  Public clouds are those run by a service provider, over a public network.  For example, Amazon Web Services offers public cloud services, among others.  A private cloud is operated for a single entity, and may be hosted internally or by a third-party service provider.  A hybrid cloud is a composition of two or more clouds, such as a private cloud and a public cloud, such that the benefits of both can be realized where appropriate.  Each of these cloud infrastructure types has different advantages and disadvantages.

For a given company looking to migrate to the cloud, the appropriate option will be motivated in part by business considerations; however, data privacy and security laws, compliance best practices, and contractual obligations will provide mandatory baselines that companies cannot ignore. As such, relevant laws, best practices, and contractual obligations serve as a useful starting point when evaluating the appropriate cloud option.

Most every organization has data flow systems that receive data, and then process and use the data to deliver a service. Below are three initial steps a decision maker should take when evaluating a potential cloud infrastructure choice.

 

First, consider the statutory implications of the types of data being processed

For example, is the system collecting social security numbers and driver’s license numbers? Pursuant to California Civil Code Section 1798.81.5, businesses that “own or license” personal information concerning a California resident are required to “implement and maintain reasonable security procedures and practices . . . to protect the personal information from unauthorized access, destruction, use modification, or disclosure.”  Of course, many other state and federal laws may also provide additional obligations, such as the HIPAA Security Rule, which applies to certain health information under certain circumstances.

Deciding which relevant laws apply, and then interpreting language such as “reasonable security procedures and practices” is a complicated process. Companies should consult experienced legal counsel regarding these risks, especially in light of potential liability.

Second, consider any relevant contractual obligations

For example, many companies may have contracts that provide for certain service level availability (SLA) obligations for services they provide. It is also possible that these contracts could have their own security requirements in place that must be met.

Third, decide which cloud architecture option makes sense in light of the first two steps as well as business considerations

After senior decision makers, with the benefit of experienced legal counsel, have decided what elements of applicable laws, best practices, and contractual obligations apply, further business considerations may need to be addressed from an operational standpoint.  For example, interoperability with other services may be an issue, or scalability may be an issue.

 

Through these requirements, in conjunction with appropriate information technology stakeholders, the appropriate cloud architecture can be chosen. Private clouds can offer the strongest security controls, as they are operated by a single entity and can offer security options not present in public clouds.  As such, a private cloud may be appropriate where a very strong security stance is deemed necessary.  Public clouds are often less expensive, but offer a more limited range of security options.  A hybrid cloud may be appropriate where an entity hosts certain high security data flow systems, as well as other systems with less sever security requirements.  For example an entity that has an HR system that contains social security numbers, as well as an employee shift scheduling system might choose to host the HR system on a private cloud, while hosting the customer feedback system on a public cloud system, with limited cross over and interoperability between the two systems.

Once you have chosen which cloud suits your business and data flow, the real work of getting appropriate contract documents in place begins.   We’ll discuss those issues in a future blog post.

 

 

Two recent data breach incidents in the healthcare industry prove what readers of this blog have heard all too often:  KNOW THY VENDORS.

Last week, Phoenix-based Banner Health reported one of the year’s largest data breaches.  Banner reported that it had suffered a massive cyberattack potentially affecting the information of 3.7 million patients, health plan members and beneficiaries, providers.   This attack is notable for all companies and not just healthcare providers covered by HIPAA.   Reportedly, the attack occurred through the computer systems that process food and beverage purchases in the Banner system.  In the incident, according to reports, the hackers gained access to the larger systems through the point-of-sale computer system that processes food and beverage purchases.  The attack was discovered on July 13, and Banner believes hackers originally gained access on June 17. Continue Reading To Protect Data: Keep Your Network Access Close, and Your Vendors Closer

The U.S. Department of Health and Human Services Office for Civil Rights (OCR)  recently issued a warning regarding vulnerabilities in third-party applications used by entities covered by HIPAA.  The OCR warning applies generally to HIPAA Covered Entities and Business Associates.  While Covered Entities and Business Associates are more cognizant of vulnerabilities in operating systems (like Windows) and install updates and patches as needed (we hope), OCR reported that companies are less likely to do the same for third-party applications (like Adobe’s Acrobat or others). Continue Reading OCR Warns of HIPAA Risks in Third-Party Apps

The number one threat to a company’s information (personal or confidential) is still its own employees. Data security and privacy training are the first lines of defense against negligent employee behavior.

Join us tomorrow (6.22) at 1 PM ET for a webinar in which we will explore why traditional training programs are falling short and what you can do to boost your efforts and counter top concerns regarding malicious and negligent employee handling of personal and confidential data.

Register here.

CLE credit available in NY and CA