Articles Posted in HIPAA

data-storage-1-1155466-m.jpgAn unencrypted thumb drive cost a dermatology practice $150,000. On December 26, 2013, the U.S. Department of Health & Human Services (HHS) announced a settlement with Adult & Pediatric Dermatology, P.C. of Concord, Massachusetts (APD) of alleged violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). APD, a “covered entity” for HIPAA purposes, has offices in Concord, Westford, Marlborough, and Ayer, Massachusetts, and Wolfeboro, New Hampshire.

The thumb drive contained unsecured electronic protected health information (ePHI) relating to the performance of Mohs surgery for about 2,200 patients. The thumb drive was stolen from the vehicle of one of APD’s employees. APD informed its patients of the theft of the thumb drive and provided a media notice.

HHS investigated and determined that APD did not timely conduct an accurate and thorough analysis of the risks associated with potential exposure of the ePHI. HHS also determined that APD did not fully comply with the administrative requirements of HIPAA’s breach notification requirements to have written policies and procedures and train employees regarding breach notification requirements. HHS also determined that APD disclosed ePHI in violation of HIPAA by the access gained to it when APD did not reasonable safeguard an unencrypted thumb drive.

HHS fined APD $150,000 and required APD’s execution of a Corrective Action Plan. The Corrective Action Plan requires APD to develop a comprehensive risk analysis and risk management plan to ensure future compliance with HIPAA and to periodically report to HHS the status of APD’s implementation of the plan. HHS released its right to take further action against APD, conditioned upon full compliance by APD with the Corrective Action Plan. See HHS Resolution Agreement.
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1177227_vintage_alarm_clock.jpgAs a general rule of thumb for legal issues, being proactive tends to be much less expensive than being reactive. This general rule certainly applies to health care providers, their business associates and, now, business associate subcontractors with respect to changes required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The HIPAA Omnibus Final Rule (Final Rule), implementing provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act passed in 2009, became law last week on March 26, 2013. The Final Rule significantly modifies HIPPA requirements for compliance and security measures intended to protect health information (PHI), especially business associate agreements. Health care covered entities and their business associates and subcontractors have six months to become compliant with the rule, or face large fines (up to $1.5 million). The deadline for compliance is September 23, 2013, and the clock is ticking. Quickly.

According to the U.S. Department of Health & Human Services (HHS), the Final Rule is intended to bolster privacy and security protections for PHI under HIPAA by greatly enhancing the government’s ability to enforce the law. Health care provider audits are expected to dramatically increase in the coming months and years. Assuming that an audit will not happen is a mistake for any health care provider. Fines for HIPAA violations can be considerable, up to $1.5 million.

Under the Final Rule, parts of the HIPAA “Security Rule” (security requirements for electronic PHI) and “Privacy Rule” (security requirements for privacy of PHI) will now apply directly to business associates so that business associates will be potentially liable for civil and criminal penalties for any non-compliance with the HIPAA regulations, rather than just a breach of contract. Additionally, many subcontractors of business associates will now be covered. Liability for data breaches and other non-compliance can lie with the subcontractor, the business associate or the covered health care entity.

So, who is a “business associate”?

This is an important question because many changes under the Final Rule will profoundly impact not only covered entities and existing business associates, but other entities that now meet the definition of “business associate” and downstream business associate subcontractors whose services touch PHI. The Final Rule broadened the definition of “business associate” so that anyone who creates, receives, maintains, or transmits PHI might be deemed subject to HIPAA rules as a business associate. For example, the new definition includes companies or persons that “maintain” PHI, such as a data storage company or a company that provides data transmission services.

Legal counsel should be consulted to determine what business partners and vendors might be deemed “business associates” by HHS in the event of an audit. The reality is that many (probably most) business associates are currently not compliant with HIPAA and, if they consider the issue at all, may be in denial. HHS has decided it will deal with the issue more aggressively. Prudent health care providers must promptly inventory their business relationships to identify all business partners and vendors that meet the broadened definition of “business associate” under HIPAA rules and ascertain whether business associates are compliant with HIPAA’s risk assessment and other compliance protocol. This process should include evaluation of existing business associate agreements and, ultimately, health care providers should insist that every business associate demonstrate compliance.

Do your business associate agreements need to be updated?

Covered entities, business associates and subcontractors have until September 23, 2013 to execute business associate agreements compliant with the Final Rule. Under the Final Rule, business associate agreements must be updated to require that:

– the business associate comply with applicable requirements of the Security Rule.

– business associate ensure subcontractors that create, receive, maintain or transmit electronic PHI on behalf of the business associate agree to comply with the requirements of the Security Rule.

– the business associate ensure that any subcontractors that create, receive, maintain or transmit PHI on behalf of the business associate agree to the same restrictions and conditions that apply to the business associate with respect to such PHI.

– the business associate report breaches of unsecured PHI.

– the business associate carry out a covered health care entity’s obligation under the Privacy Rule (e.g., serving as the privacy official)

– the business associate comply with the requirements of the Privacy Rule that apply to the performance of such obligation.

It is estimated that up to 500,000 existing Business Associates will have to have new business associate agreements.
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1221952_to_sign_a_contract_3.jpgThe U.S. Department of Health and Human Services (HHS) published the HIPAA final omnibus rule (Final Rule) on January 25, 2013. The Final Rule deals with required changes for medical practices and other health care providers that HHS determined are necessary to secure protected health information (PHI). As a result of the Final Rule, many health care providers must update existing business associate agreements, revise existing notices of privacy practice, and require some business associates’ subcontractors to execute business associate agreements. For many medical practices and health care businesses, this process may be a tedious undertaking and, therefore, should begin promptly. The deadline for compliance is September 23, 2013.

A “business associate” is a person or entity that acts on behalf of or provides services to a health care provider (a “covered entity”) who, by doing so, obtains access to PHI. The purpose of a business associate agreement is to ensure business associates will appropriately safeguard PHI and limit permissible uses and disclosures of PHI, to protect patient privacy and related purposes advanced by HIPAA. A business associate is directly liable under HIPAA and subject to civil (and potentially criminal) penalties for data breaches and other violations of HIPAA.

The Final Rule is published in the Federal Register (78 FR 5565) and is 523 pages. Under the Final Rule, a “business associate” includes a broader scope of entities. “Business associate” now includes subcontractors and entities that create, receive, maintain, or transmit PHI. How this change will impact particular situations may require determinations on an ad hoc basis. All physicians, physician groups, other health care providers, and health care businesses, should promptly marshal their existing business associate agreements for review and analysis to determine which agreements must be changed to comply with the Final Rule. Additionally, all business arrangements need to be inventoried and reviewed for a determination as to whether the relationship necessitates a business associate agreement under the Final Rule. For every business arrangement that will require a new business associate agreement, the business associate should be contacted now regarding the requirement of a business associate agreement.
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1269437_laptop_and_cellphone[1].jpgA single unencrypted laptop computer containing electronic protected health information (ePHI) cost The Hospice of North Idaho (HONI) $50,000. HONI agreed to pay the U.S. Department of Health and Human Services (HHS) a $50,000 fine to settle potential breaches of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.

HONI regularly used laptops in field work. However, according to HHS, HONI did not conduct an accurate and thorough analysis of the risk to the confidentiality of ePHI posed by mobile devices on an on-going basis as part of its security management process in violation of HIPAA. HONI also failed to implement security measures sufficient to ensure the confidentiality of ePHI that it created, maintained and transmitted using portable devices, another alleged HIPAA breach. In addition to the fine, HHS required HONI to enter into a corrective action plan.

The HONI settlement is notable as the first settlement of an alleged HIPAA violation based on breach of ePHI affecting fewer than 500 individuals. The government discovered in its investigation that HONI simply failed to conduct any risk assessment to safeguard ePHI and failed to have policies and procedures to address mobile devices. Leon Rodriquez, the Director of the HHS Office for Civil Rights, explained: “This action sends a strong message to the health care industry that, regardless of size, covered entities must take action and will be held accountable for safeguarding their patients’ health information.”
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1066058_patrol_hat_too[1].jpgThe Health Information Technology for Economic and Clinical Health (HITECH) Act requires the U.S. Department of Health and Human Resources (HHS) to conduct audits to ensure health care providers, health care industry organizations, and their business associates comply with HIPAA. The HHS Office for Civil Rights (OCR) audit program scrutinizes policies and procedures (or lack of same) of HIPAA-covered entities. Audit protocol looks at many elements (which may vary based on the type of covered entity audited) categorized as privacy requirements, security requirements, and breach notification requirements. The OCR makes available its audit protocol for public review online. OCR awarded KPMG a $9.2 million contract to create HIPAA auditing protocols and to handle audits. The government is keen on these audits; audits will increase in the near future.

According to OCR, “To avoid enforcement penalties, covered entities must ensure they are always in compliance with the HIPAA Privacy and Security Rules.” Be prepared. Do not wait for an audit notice. A few of the many factors potentially relevant if your medical practice or other health care business is selected for the review include:

Is there a signed business associate agreement with each business associate?

Do you encrypt protected health information (PHI)?

Do you have policies and procedures in place for employees (new employees, existing employees, terminated employees, etc.)?

Do you have policies in place with regard to the removal of PHI from the medical practice site (e.g. a smartphone)?

Do you have a written policy for ascertaining and reporting a security breach?

Do your policies cover everything you do with PHI?

Do you really do things consistently with your existing policies?

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The final Health Insurance Portability and Accountability Act (HIPAA) rule was announced on January 17, 2013, modifying the original 1996 version. The rule becomes effective on March 26, 2013, with full compliance mandated by September 23, 2013. After that, enforcement will commence.

Under the new rule, patients have new rights to their health information, greater privacy protection and the government has increased ability to enforce the law.

It is time to begin implementing a reporting plan for covered entities and business associates. Such a plan should consider four factors. Those factors to be considered in determining whether a breach must be reported include: (1) the type of protected health information (PHI) involved; (2) who used the PHI or to whom the PHI was disclosed; (3) whether the PHI was viewed or acquired; and (4) whether the risk to the PHI was mitigated, such as through assurances by trusted third parties that the PHI was destroyed.

Some other changes to be aware of are:

• Business associates are liable for HIPAA privacy and security rule requirements.

• A business associate includes subcontractors that create, receive, maintain or transmit PHI on the behalf of a business associate.

• Subcontractors for business associates are bound by the same compliance obligations no matter how far away the services are from the covered entity.

• A breach is any wrongful use or disclosure of PHI unless the covered entity or business associate assures that there was no compromise of the PHI or a small chance that it was.

• Covered entities have to protect the PHI of a decedent for 50 years following the date of death.

• Patients can request a copy of their electronic medical record (EMR) in an electronic form.

• For all practical purposes the sale of a patient’s PHI is prohibited without their authorization.

• Penalties are enhanced for noncompliance depending upon the level of culpability up to the civil monetary cap of $1.5 million per violation.

Navigating the expanded HIPAA rule and making certain that you are in compliance by September 23, 2013 can be a daunting task for small and large healthcare businesses, physicians, dentists and hospitals.
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