Get Ready Now for Toughened HIPAA/HITECH Act Privacy and Security Rules and Enforcement, and Big Noncompliance Fines

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted on August 21, 1996, as Public Law 104-191.   HIPAA Administrative Simplification provisions in Subtitle F, Title II included transactions and code sets, privacy, security, and unique identifiers.  Except for several identifiers, the federal government promulgated enabling regulations under the Administrative Procedure Act.  For example, the Privacy Rule required compliance by healthcare providers, healthcare clearinghouses, and health plans—Covered Entities—by April 14, 2003, and the Security Rule required compliance by April 20, 2005, with small health plans for each rule having an additional year in which to comply. On February 17, 2009, the Health Information Technology for Economic and…

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Nearly 8.3 Million Individuals Impacted by 249 Privacy and Security Breaches Reported by HHS; More Training on Safeguarding PHI Required

Under the Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the American Recovery and Reinvestment Act of 2009, covered entities are required to report to the Secretary of the U.S. Department of Health and Human Services (HHS) any privacy or security breach affecting 500 or more individuals within 60 days of discovery of the breach by the covered entity or its business associate.  The HHS Office for Civil Rights (OCR), which is responsible for privacy and security enforcement under the Health Insurance Portability and Accountability Act (HIPAA) and HITECH Act provisions that strengthened privacy and security enforcement, is required to post those breaches…

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Final Rules for EHR Incentives and Certification Criteria at OMB for Review

The Office of Management and Budget (OMB) received in early July for Executive Order (EO) 12866 Regulatory Planning and Review two Final Rules relating to electronic health record (EHR) incentives and certification criteria required under the Health Information Technology for Economic and Clinical Health Act (HITECH Act) that was enacted on February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009. On Friday, July 2, 2010, OMB received from the Office of the Secretary at the Department of Health and Human Services (HHS) for review Health Information Technology:  Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule.  The Interim Final…

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FTC Delays “Red Flags” Rule for Third Time

The Federal Trade Commission announced a third delay, from August 1, 2009, to November 1, 2009, for compliance with the identity theft prevention red flags rule. The delay is for another three months.  Compliance originally was scheduled for November 1, 2008, then delayed the first time until May 1, 2009.  Entities affected are creditors and financial institutions. Healthcare providers that extend delayed payment plans to patients are deemed “creditors” under the red flags rule. This delay was to give affected entities more time to develop and implement written identity theft prevention policies and procedures for compliance with the rule, which is based on enabling regulations of provisions in the Fair and Accurate…

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Person or Entity Authentication: What This HIPAA Security Rule Technical Safeguard Standard Means

This is the fourth Technical Safeguard Standard of the HIPAA Administrative Simplification Security Rule.  There is not a separately described implementation specification.  Rather, this standard’s implementation specification is connoted in the language of the standard and is required.  As we have noted in earlier postings on HIPAA.com, business associates of covered entities will be required to comply with the Security Rule safeguard standards, beginning February 17, 2010.  This requirement is one of the HITECH Act provisions of the American Recovery and Reinvestment Act (ARRA), signed by President Obama on February 17, 2009. For compliance with this Technical Safeguard Standard, a covered entity is required to implement procedures to verify that…

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Integrity: Mechanism to Authenticate Electronic Protected Health Information-What to Do and How to Do It

In our series on the HIPAA Administrative Simplification Security Rule, this is the  implementation specification for the third Technical Safeguard Standard, Integrity. This implementation specification is addressable. Addressable does not mean “optional.” Rather, an addressable implementation specification means that a covered entity must use reasonable and appropriate measures to meet the standard. As we noted in earlier postings on HIPAA.com, business associates of covered entities will be required to comply with the Security Rule safeguard standards, beginning February 17, 2010. This requirement is one of the HITECH Act provisions of the American Recovery and Reinvestment Act (ARRA), signed by President Obama on February 17, 2009. What to Do Implement electronic…

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Access Control: What This HIPAA Security Rule Technical Safeguard Standard Means

This is the first Technical Safeguard Standard of the HIPAA Administrative Simplification Security Rule. It has four implementation specifications:  unique user identification; emergency access procedure; automatic logoff; and encryption and decryption. The first two are required; the last two are addressable. Addressable does not mean “optional.” Rather, an addressable implementation specification means that a covered entity must use reasonable and appropriate measures to meet the standard. As we have noted in earlier postings on HIPAA.com, business associates of covered entities will be required to comply with the Security Rule safeguard standards, beginning February 17, 2010. This requirement is one of the HITECH Act provisions of the American Recovery and Reinvestment…

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Device and Media Controls: What This HIPAA Security Rule Physical Safeguard Standard Means

This is the fourth and last Physical Safeguard Standard of the HIPAA Administrative Simplification Security Rule.  It has four implementation specifications:  disposal, media re-use, accountability, and data backup and storage.  The first two are required; the last two are addressable.  Addressable does not mean “optional.”  Rather, an addressable implementation specification means that a covered entity must use reasonable and appropriate measures to meet the standard.  As we have noted in earlier postings on HIPAA.com, business associates of covered entities will be required to comply with the Security Rule safeguard standards, beginning February 17, 2010.  This requirement is one of the HITECH Act provisions of the American Recovery and Reinvestment Act…

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Physical Safeguard Standard, Workstation Use-What to Do and How to Do It

In our series on the HIPAA Administrative Simplification Security Rule, Workstation Use is the second Physical Safeguard Standard.  There is no defined implementation specification for this standard.  Implementation of policies and procedures pertaining to this standard are required.  As we have noted in earlier postings on HIPAA.com, business associates of covered entities will be required to comply with the Security Rule safeguard standards, beginning February 17, 2010.  This requirement is one of the HITECH Act provisions of the American Recovery and Reinvestment Act (ARRA), signed by President Obama on February 17, 2009. What is Required A covered entity must implement policies and procedures that specify the proper functions to be…

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FTC Delays Identity Theft Prevention Red Flags Rule for Second Time

The Federal Trade Commission announced a second delay on Friday, May 1, 2009, for compliance with the identity theft prevention red flags rule. The delay is for three months, with compliance now scheduled for August 1, 2009. Entities affected are creditors and financial institutions. Healthcare providers that extend delayed payment plans to patients are deemed “creditors” under the red flags rule. This delay was to give affected entities more time to develop and implement written identity theft prevention policies and procedures for compliance with the rule, which is based on enabling regulations of provisions in the Fair and Accurate Credit Transactions Act of 2003. You can visit the FTC website…

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