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Next Generation of Patient Care: Balancing Digital Engagement with Patient and Consumer Privacy

Jennifer Geetter and Lisa Schmitz Mazur wrote this bylined article on the regulatory implications of technology-supported devices, resources, and solutions that facilitate health patient-provider interaction. “Health industry regulators are struggling with how to apply the existing privacy regulatory regime, and the permitted uses and disclosures for which they provide, in this new world of healthcare innovation,” the authors wrote.

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Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

On July 28, 2016, US Department of Health and Human Services (HHS) issued guidance (guidance) under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and recover from ransomware attacks. Ransomware attacks can also trigger concerns under state data breach notification laws.

The HIPAA Security Rule requires covered entities and business associates to implement security measures. It also requires covered entities and business associates to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information (ePHI) the entities create, receive, maintain or transmit and to implement security measures sufficient to reduce those identified risks and vulnerabilities to a reasonable and appropriate level. The HIPAA Security Rule establishes a floor for the security of ePHI, although additional and/or more stringent security measures are certainly permissible and may be required under state law. Compliance with HIPAA’s existing requirements provides covered entities and business associates with guidance on how to prevent and address breaches that compromise protected health information. The new HIPAA guidance specific to ransomware reinforces how the existing requirements can help an entity protect sensitive information.

Read the full article here.




With No Federal Law in Sight, States Continue to Refine Their Own Data Privacy Laws

With no Congressional consensus to adopt a federal data privacy and breach notification statute, states are updating and refining their already-existing laws to enact more stringent requirements for companies.  Two states recently passed updated data privacy laws with significant changes.

Rhode Island

The Rhode Island Identity Theft Protection Act (Rhode Island Data Law), an update to Rhode Island’s already-existing data security and breach notification law, introduces several new requirements for companies that store, collect, process, use or license personal identifying information (PII) about Rhode Island residents.

A few of these provisions are particularly noteworthy.  First, the new law requires entities to “implement and maintain a risk-based information security program which contains reasonable security procedures and practices,” scaled to the size of the entity and the type of personal information in its possession.  Second, the Rhode Island Data Law requires that any entity that discloses PII to a third party have a written contract with the third party pursuant to which the third party will also implement and maintain an information security program to protect the personal information.  Third, the Rhode Island Data Law requires any entity that experiences a data breach of personal information to notify affected residents within 45 calendar days after it knows that a breach has occurred.  (Rhode Island also required this under its previous law, but there was no precise time frame.)  Among other information, the notification must now contain information about data protection services to be offered to the resident, as well as information about how the resident can request a security credit freeze.

Under both the old and new laws, a health care provider, insurer or covered entity that follows the medical privacy and security rules established by the federal government pursuant to the Health Insurance Portability and Accountability Act (HIPAA) is deemed compliant with the law’s requirements.  The Rhode Island Data Law will become effective June 26, 2016.

Connecticut

The Connecticut Act Improving Data Security and Effectiveness (Connecticut Data Law) similarly updates Connecticut’s existing law and introduces more stringent requirements for entities that that store, collect, process, use or license PII about Connecticut residents.

Perhaps most noteworthy, the Connecticut Data Law puts in place important new requirements about notification following a data breach.  Unlike the older Connecticut breach notification law, the Connecticut Data Law now requires an entity to notify affected individuals of a data breach within a set time period of 90 days.  In addition, if the breach involves disclosure of Social Security numbers, the entity must also provide free credit monitoring services to individuals for one year.  Many companies provide credit monitoring at no cost to their customers affected by a data breach voluntarily.  However, laws like Connecticut’s make credit monitoring a mandatory part of any company’s response.

Additionally, the Connecticut Data Law imposes significant new requirements on insurers and state contractors that handle PII.  Health insurers are required to develop and follow a written data security program, and to certify annually to [...]

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States Respond to Recent Breaches with Encryption Legislation

In the wake of recent breaches of personally identifiable information (PII) suffered by health insurance companies located in their states, the New Jersey Legislature passed, and the Connecticut General Assembly will consider legislation that requires health insurance companies offering health benefits within these states to encrypt certain types of PII, including social security numbers, addresses and health information.  New Jersey joins a growing number of states (including California (e.g., 1798.81.5), Massachusetts (e.g., 17.03) and Nevada (e.g., 603A.215)) that require organizations that store and transmit PII to implement data security safeguards.   Massachusetts’ data security law, for example, requires any person or entity that owns or licenses certain PII about a resident of the Commonwealth to, if “technically feasible” (i.e., a reasonable technological means is available), encrypt information stored on laptops and other portable devices and encrypt transmitted records and files that will travel over public networks.  Unlike Massachusetts’ law New Jersey’s new encryption law only applies to health insurance carriers that are authorized to issue health benefits in New Jersey (N.J. Stat. Ann. §  56:8-196) but requires health insurance carriers to encrypt records with the PII protected by the statute when stored on any end-user systems and devices, and when transmitted electronically over public networks (e.g., N.J. Stat. Ann. § 56.8-197).

At the federal level, the Health Insurance Portability and Accountability Act (HIPAA) already requires health plans, as well as other “covered entities” (i.e., health providers)  and their “business associates” (i.e., service providers who need access to a covered entity’s health information to perform their services), to encrypt stored health information or health information transmitted electronically if “reasonable and appropriate” for them to do so (45 C.F.R. §§ 164.306; 164.312).  According to the U.S. Department of Health and Human Services, health plans and other covered entities and their business associates should consider a variety factors to determine whether a security safeguard is reasonable and appropriate, including: (1) the covered entity or business associate’s risk analysis; (2) the security measures the covered entity or business associate already has in place; and (3) the costs of implementation (68 Fed. Reg. 8336).  If the covered entity or business associate determines that encryption of stored health information or transmitted information is not reasonable and appropriate, however, the covered entity or business associate may instead elect to document its determination and implement an equivalent safeguard.

The New Jersey law and the Connecticut proposal appear to reflect a legislative determination that encryption of stored or transmitted health information is always reasonable and appropriate for health plans to implement, regardless of the other safeguards that the health plan may already have in place.  As hackers become more sophisticated and breaches more prevalent in the health care industry, other states may follow New Jersey and Connecticut by expressly requiring health plans and other holders of health care information to implement encryption and other security safeguards, such as multifactor authentication or minimum password complexity requirements.  In fact, Connecticut’s Senate [...]

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Pressure Points: OCR Enforcement Activity in 2014

During 2014, the Office for Civil Rights (OCR) of the U.S. Department of Health & Human Services initiated six enforcement actions in response to security breaches reported by entities covered by the Health Insurance Portability and Accountability Act (HIPAA) (covered entities), five of which involved electronic protected health information (EPHI).  The resolution agreements and corrective action plans resolving the enforcement actions highlight key areas of concern for OCR and provide the following important reminders to covered entities and business associates regarding effective data protection programs.

  1. Security risk assessment is key.

OCR noted in the resolution agreements related to three of the five security incidents, involving QCA Health Plan, Inc., New York and Presbyterian Hospital (NYP) and Columbia University (Columbia), and Anchorage Community Mental Health Services (Anchorage), that each entity failed to conduct an accurate and thorough assessment of the risks and vulnerabilities to the entity’s EPHI and to implement security measures sufficient to reduce the risks and vulnerabilities to a reasonable and appropriate level.  In each case, the final corrective action plan required submission of a recent risk assessment and corresponding risk management plan to OCR within a relatively short period after the effective date of the resolution agreement.

      2.  A risk assessment is not enough – entities must follow through with remediation of identified threats and vulnerabilities.

In the resolution agreement related to Concentra Health Services (CHS), OCR noted that although CHS had conducted multiple risk assessments that recognized a lack of encryption on its devices containing EPHI, CHS failed to thoroughly implement remediation of the issue for over 3-1/2 years.

      3.  System changes and data relocation can lead to unintended consequences. 

In two of the cases, the underlying cause of the security breach was a technological change that led to the public availability of EPHI.  A press release on the Skagit County incident notes that Skagit County inadvertently moved EPHI related to 1,581 individuals to a publicly accessible server and initially reported a security breach with respect to only seven individuals, evidentially failing at first to identify the larger security breach.  According to a press release related to the NYP/Columbia security breach, the breach was caused when a Columbia physician attempted to deactivate a personally-owned computer server on the network, which, due to lack of technological safeguards, led to the public availability of certain of NYP’s EPHI on internet search engines.

      4.  Patch management and software upgrades are basic, but essential, defenses against system intrusion.

OCR noted in its December 2014 bulletin on the Anchorage security breach (2014 Bulletin) that the breach was a direct result of Anchorage’s failure to identify and address basic security risks. For example, OCR noted that Anchorage did not regularly update IT resources with available patches [...]

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When Seeking Cyber Coverage, Preparation is Key

In 2014, major data breaches were reported at retailers, restaurants, online marketplaces, software companies, financial institutions and a government agency, among others.  According to the nonprofit Privacy Rights Clearinghouse, 567 million records have been compromised since 2006.  Companies with data at risk should consider purchasing so-called cybersecurity insurance to help them weather storms created by assaults on their information infrastructure.  A company’s insurance broker and insurance lawyer can be of significant help in procuring insurance that meets a company’s need.

As an additional benefit, preparation for the cybersecurity insurance underwriting process itself likely will decrease the risk of a debilitating cyber incident.  The underwriting process for cybersecurity insurance is focused on the system that a company employs to protect its sensitive data, and can be detailed and exhaustive.  Like other insurance carriers, cybersecurity insurance carriers use the underwriting process to investigate prospective policyholders and ascertain the risks the carriers are being asked to insure.  Before applying for cybersecurity insurance, companies should perform due diligence on their information systems and correct as many potential risks as possible before entering the underwriting process.

Applicants for cybersecurity insurance may expect to answer questions about prior data breaches, information-technology vendors, antivirus and security protocols, and the species of data in their custody.  Carriers might also ask about “continuity plans” for the business, the company’s security or privacy policies, whether those policies are the product of competent legal advice, whether the company’s networks can be accessed remotely and, if so, what security measures are in place.  The investigation might even extend to a company’s employment practices, such as password maintenance and whether departing employees’ network access is cancelled prior to termination.  If a company has custody of private health information, carriers might delve into a company’s compliance with the Health Insurance Portability and Accountability Act of 1996.  Anything that makes a company more or less at risk for a data breach is fair game in the cybersecurity underwriting process.

Due diligence and corrective action prior to approaching an insurance company should yield three related results.  First, it should reduce the company’s risk of a data breach.  Because the insurance carriers are focused on what makes a company a larger or smaller risk to underwrite, companies can use carriers’ underwriting questions as a roadmap to improving the security of their information-technology systems.  Second, it should make the company more attractive to the prospective insurance company.  Insurance companies obviously prefer policyholders that do not present substantial risk of claims.  A company’s ability to present its systems as safe and secure will give a carrier a greater degree of comfort in reviewing and approving the application for insurance.  Finally, it should reduce the company’s premium for cybersecurity insurance.  Premium rates have a simple, direct relationship with risk.  As a policyholder’s risk profile increases, so too does the premium.  Shoring up gaps in a company’s security profile therefore should pay dividends in lower insurance costs.

Companies with sensitive data in their care should investigate options for cybersecurity insurance.  In [...]

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New Data Disposal Law in Delaware Requires Action by Impacted Businesses

While the federal government continues its inaction on data security bills pending in Congress, some U.S. states have been busy at work on this issue over the summer.  A new Delaware law H.B. 295, signed into law on July 1, 2014 and effective January 1, 2015, provides for a private right of action in which a court may order up to triple damages in the event a business improperly destroys personal identifying information at the end of its life cycle.  In addition to this private right of action, the Delaware Attorney General may file suit or bring an administrative enforcement proceeding against the offending business if it is in the public interest.

Under the law, personal identifying information is defined as:

A consumer’s first name or first initial and last name in combination with any one of the following data elements that relate to the consumer, when either the name or the data elements are not encrypted:

  • his or her signature,
  • full date of birth,
  • social security number,
  • passport number, driver’s license or state identification card number,
  • insurance policy number,
  • financial services account number, bank account number,
  • credit card number, debit card number,
  • any other financial information or
  • confidential health care information including all information relating to a patient’s health care history, diagnosis condition, treatment or evaluation obtained from a health care provider who has treated the patient, which explicitly or by implication identifies a particular patient.

Interestingly, this new law exempts from its coverage:  banks and financial institutions that are merely subject to the Gramm-Leach-Bliley Act, but the law only exempts health insurers and health care facilities if they are subject to and in compliance with the Health Insurance Portability and Accountability Act (HIPAA), as well as credit reporting agencies if they are subject to and in compliance with the Fair Credit Reporting Act (FCRA).

Given how broadly the HIPAA and FCRA exemptions are drafted, we expect plaintiffs’ attorneys to argue for the private right of action and triple damages in every case where a HIPAA- or FCRA-covered entity fails to properly dispose of personal identifying information, arguing that such failure evidences noncompliance with HIPAA or FCRA, thus canceling the exemption.   Note, however, that some courts have refused to allow state law claims of improper data disposal to proceed where they were preempted by federal law.  See, e.g., Willey v. JP Morgan Chase, Case No. 09-1397, 2009 U.S. Dist. LEXIS 57826 (S.D.N.Y. July 7, 2009) (dismissing individual and class claims alleging improper data disposal based on state law, finding they were pre-empted by the FCRA).

The takeaway?  Companies that collect, receive, store or transmit personal identifying information of residents of the state of Delaware (or any of the 30+ states in the U.S. that now have data disposal laws on the books) should examine their data disposal policies and practices to ensure compliance with these legal requirements.  In the event a business is alleged to have violated one of [...]

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Trendy “Cybersecurity” Versus Traditional “Information Security” Two Sides of the Same Security Coin

Cybersecurity has become a dominant topic of the day.  The Snowden revelations, the mega-data breaches of 2013, the pervasiveness of invisible online “tracking” and the proliferation of “ data broker” trading in personal data – all feed into the fears of individuals who struggle to understand how their personal information is collected, used and protected.  Over the past year, these forces have begun to merge an old concern by individuals about the security of their personal information into a broader, more universal fear that the country’s infrastructure lay vulnerable.

In many respects, however, the concept of cybersecurity is not new.  Cybersecurity is a form of information security, albeit perhaps with a broader, more universal view of required security controls.  Decades-old statutes include information security requirements for certain types of information, the Health Insurance Portability and Accountability Act (HIPAA) addresses health information and the Gramm-Leach-Bliley Act (GLBA) addresses financial information.  Add to those statutory regimes the U.S. Federal Trade Commission’s (FTC) enforcement authority over corporate information security practices pursuant to Section 5 of the FTC Act (recently upheld in Federal Trade Comm’n v. Wyndham Worldwide Corp.) and certain state-based data security regulations that require corporations to safeguard personal information (e.g., 201 CMR 17.00, et seq.).  The net effect of these regulatory drivers is that many organizations have focused for decades on developing administrative, physical and technical safeguards for effective protection of personal information – resulting in a programmatic approach to information security.

Now, along comes the evolution of cybersecurity with its own emerging standards.  Organizations are asking themselves whether they need to do something different or in addition to the programmatic steps already taken to comply with information security requirements that are applicable to the organization.  The good news is that while some additional work likely will be required as described below, companies with solid programmatic approaches to information security are well on their way to meeting the following emerging cybersecurity standards.

NIST Cybersecurity Framework

On February 12, 2013, President Obama issued an Executive Order entitled “Improving Critical Infrastructure Cybersecurity.”  The Executive Order has several key components, but most importantly, it contains a requirement for owners and operators of “critical infrastructure” to develop a cybersecurity framework.  The Order directed the National Institute of Standards and Technology (NIST) to develop a baseline cybersecurity framework to reduce cyber risks to critical infrastructure.  NIST subsequently developed its “Framework for Improving Critical Infrastructure Cybersecurity” (Framework), which was released on February 12, 2014.  The goal of these efforts is to provide organizations with a cybersecurity framework as a model for their business.  While at this point, the Framework is intended to provide a voluntary program for owners and operators of critical infrastructure, it is already starting to seep into federal “incentives” used to encourage the private sector to comply with the Framework.  And the Framework itself may evolve into a sort of “security” standard of care.

SEC Cybersecurity and Disclosure Laws

In addition to the Framework, the U.S. Security and Exchange Commission (SEC) recently [...]

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