This article discusses techniques for implementing the updated requirements of the HIPAA Security Rule, with particular focus on strategies for assessing the effectiveness of implemented security controls to support compliance and audit, as well as a covered entity’s (or business associate) overarching risk management program in the context of HIPAA Compliance. Covered entities are becoming more pro-active in monitoring their business associate compliance with HIPAA privacy and security regulations and the recent changes largely the product of the HITECH Act. In the past I have used a series of questions to ascertain the compliance status of business associates to comply with HIPAA privacy and security rules. I find it useful to map security controls to NIST Special Publication 800-53. The National Institute of Standards and Technology has collaborated with the military and intelligence communities to produce the first set of security controls for all government information systems, including national security systems. The controls are included in the final version of Special Publication 800-53, Revision 3 “Recommended Security Controls for Federal Information Systems and Organizations,” released in August of 2009. (Available at http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final.pdf). [...]
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By Robert Hudock, on November 29th, 2009
 Print This PostNovember 29th, 2009 | Tags: 800-53, 800-66, compliance, HIPAA, HITECH Act, NIST, security controls | Category: American Recovery and Reinvestment Act, Data Hemorrages, Destruction, Encryption, FIPS 140-2, Federal Agencies, HIPAA Security, HITECH Act, Health Information Technology, Health Reform, Health and Humans Services (HHS), Individually identifiable health information, Interoperability, Meaningful Use, Media Sanitization, NIST, Office of Civil Rights, Privacy, SSL VPNs, anonymization, unsecured protected health information |
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Print This PostBy Robert Hudock, on November 17th, 2009
Print This PostNext year should be interesting. From Red Flag compliance, federal breach reporting requirements, significantly augmented HIPAA penalties, and HIPAA security standards that are based on NIST guidelines will change the traditional compliance model for Covered Entities and Business Associates. Hot topics for enforcement next year (based on recent CMS audits of their business partners) will likely be in the areas encryption of portable media devices, remote access by employees to protected health information, and failure to document a rational risk management [...] November 17th, 2009 | Tags: ARRA, breach, EHR, Encryption, enforcement actions, FISMA, HIPAA, Interoperability, NIST, OIG, security | Category: American Recovery and Reinvestment Act, EMR, Encryption, FIPS 140-2, HIPAA Security, HITECH Act, Health Information Technology, Health and Humans Services (HHS), Interoperability, Meaningful Use, NIST, unsecured protected health information |
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Print This PostBy Robert Hudock, on September 22nd, 2009
Print This PostI am a little unclear as to why privacy advocates and security vendors believe that the harm standard, found within the new HHS regulations for security breaches, in any way hampers the HITECH Act’s security breach notice rule for covered entities and business associates. Many states use a similar risk based type analysis, in fact only seven states have a strict acquisition based standard, of those only a couple of these states link their definition of encryption to FIPS 140-2. In comparison to risk based states where one assesses the potential risk to a consumer resulting from theft of sensitive informatioin, the federal standard is more helpful in the sense that it highlights key criteria to be evaluated in assessing risk to consumers. [...] September 22nd, 2009 | Tags: fear mongering, FIPS 140-2, FISMA, harm standard, HIPAA, OMB, Risk Analysis, security incident | Category: Computer Security Law -- Federal, Data Hemorrages, Encryption, FIPS 140-2, HIPAA Privacy, HIPAA Security, HITECH Act, Health and Humans Services (HHS), Identity Theft, Individually identifiable health information, NIST, Privacy, State Security Breach Laws, unsecured protected health information |
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Print This PostBy Kristen McDonald, on September 15th, 2009
Print This PostWhat happens if the offices of a covered entity are broken into and unsecured protected health information (PHI) of more than 500 individuals is stolen? With the enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act,1 the ramifications to the covered entity and potential liability stemming from such a breach2 are significant to say the least. Not only is the covered entity required to notify the affected individuals of the breach of unsecured PHI,3 but also the covered entity must notify the media and the Department of Health and Human Services Secretary (HHS Secretary) of potentially damaging information concerning the breach. The HITECH Act’s requirement to report details of a significant breach not only to the affected individuals but also to the media and the Secretary may negatively impact the covered entity’s goodwill in the community and cause a loss of business. Of particular concern to the covered entity’s litigation counsel, though, is the potential liability that the covered entity may face due to the [...] September 15th, 2009 | Tags: Damages, HHS, HIPAA, HITECH Act, litigation, PHI, security, significant breach, unsecured PHI | Category: Computer Security Law -- Federal, Damages, HIPAA Privacy, HIPAA Security, HITECH Act, Health and Humans Services (HHS), Identity Theft, Individually identifiable health information, Office of Civil Rights, unsecured protected health information |
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Print This PostBy Robert Hudock, on September 11th, 2009
Print This PostSocial networking sites, efficient search tools (bing, dogpile, google, yahoo), blogs, cookies, mailing lists, message boards, active x controls/ embedded java script on websites and other databases make it easy to identify that new business prospect or easily cross-reference materials from multiple sources to yield unique insights into a matter of interest. However, these online repositories of data are making it much more difficult to maintain the anonymity of those whose confidential information has been de-identified. De-identified data has many useful purposes; the data can be used in its aggregate for tracking disease, flu outbreaks, tax purposes, etc. There is a darker use of these many data sources, where those in our society that are ethically challenged use these data sources for socially unproductive purposes. [...] September 11th, 2009 | Tags: adversary, auxiliary information, census data, cyber harrasment, cyber stalking, data fingerprint, de-identified, HIPAA, identify, PHI, PII, re0identified | Category: CMS, Computer Security Law -- Federal, Deidentified Health Information, HIPAA Privacy, Health and Humans Services (HHS), Identity Theft, Individually identifiable health information, Law and Technology, Privacy, Safe Harbor Method, unsecured protected health information |
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Print This PostBy Robert Hudock, on August 21st, 2009
Print This PostRegulations requiring health care providers, health plans, and other entities covered by the Health Insurance Portability and Accountability Act (HIPAA) to notify individuals when personal health information is breached were issued August 19th, 2009, by the U.S. Department of Health and Human Services (HHS). These “breach notification” regulations implement provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, passed as part of American Recovery and Reinvestment Act of 2009 [...] August 21st, 2009 | Tags: Data at Rest, Data Disposed, Data in Motion, Data in Use, Destruction, Encryption, FTC, Health Breach Notification Rule - FTC, HHS, HIPAA, OCR, paper, redaction, Report, security breach | Category: American Recovery and Reinvestment Act, Computer Security Law -- Federal, Encryption, FIPS 140-2, FTC Security Breach Notification, HIPAA Security, HITECH Act, Health and Humans Services (HHS), Media Sanitization, NIST, Office of Civil Rights, unsecured protected health information |
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Content of the Notice to the Secretary of HHS for a Reportable Security Breach
Under the HITECH breach notification requirements, covered entities must notify HHS of all reportable breaches. HHS recently released a list of breaches, including the covered entity, the business associate, number of individuals affected, and the location of the information lost. More than 35 HIPAA covered entities have reported breaches involving more than 500 individuals’ PHI since September 2009. The theft/loss of laptops, desktop and portable media by far represent the majority of the security breaches reported thus far. A summary of breaches reported thus far appears [...]