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 [...]
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By Robert Hudock, on March 1st, 2010
 Print This PostMarch 1st, 2010 | Tags: Department of Health and Human Services, Freedom of Information Act, health information, HIPAA, HITECH Act, security breach | Category: HITECH Act, Health Information Technology, Health Reform, Health and Humans Services (HHS), Office of Civil Rights, unsecured protected health information |
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Print This PostBy Robert Hudock, on December 10th, 2009
Print This PostOn December 1st, 2009 the Office of the Secretary of the Office of the National Coordinator (ONC) for Health Information Technology announced the creation of a new Chief Privacy Office and the Office of Economic Modeling and Analysis (among three others including the Office of Chief Scientist, Deputy National Coordinator for Programs & Policy, and Deputy National Coordinator for Operations). The New Chief Privacy Officer is a necessary creation under the ARRA (and the HITECH Act). This role is different from the other positions that seem to be a re-organization of roles and responsibilities that already existed to some extent just with more specificity around functions and duties. Aside from the Chief Privacy Officer the New Economic Modeling and Analysis Position seems like a timely creation given recent articles discussing whether Health Information Technology and more specifically Electronic Health Record Systems (EHRs) actually reduce the cost of care and/or increase the quality of care. Also of note, the new Office of the Deputy National Coordinator for Programs and Policy will be responsible for the open source Connect initiative and the National Health Information [...] December 10th, 2009 | Tags: ARB, ARC, ARD, ARF, ARRA, HITECT, Office of Economic Modeling and Analysis, Office of the Chief Privacy Officer, Office of the Chief Scientist, Office of the Deputy National Coordinator for Programs & Policy, ONC | Category: American Recovery and Reinvestment Act, HIPAA Privacy, HIPAA Security, HITECH Act, Health Information Technology, Health and Humans Services (HHS), Interoperability, Office of the National Coordinator for Health Information Technology |
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Print This PostBy Robert Hudock, on November 29th, 2009
Print This PostThis 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). [...] November 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 October 15th, 2009
Print This PostOn October 7, 2009 HHS announced proposed rulemaking to modify the HIPAA privacy rule to comply with Section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA) regarding the privacy and confidentiality of genetic information. Generally, the HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically. The HIPAA Privacy Rule requires a covered entity (and beginning next year Business Associates) to implement reasonable and appropriate administrative, technical and physical safeguards to protect the privacy of personal health information (PHI). The HIPAA privacy rule more generally sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The Rule also gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request [...] October 15th, 2009 | Tags: genetic information, Genetic Information Nondiscrimination Act of 2008, gina, HIPAA, PHI | Category: Deidentified Health Information, Federal Agencies, Genetic Information Nondiscrimination Act of 2008, HIPAA Privacy, HITECH Act, Health and Humans Services (HHS), Office of Civil Rights, Privacy, Privacy Law, State Privacy and Computer Security Laws, anonymization |
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Print This PostBy Robert Hudock, on October 12th, 2009
Print This PostGenerally in the event of a “breach” of “unsecured” PHI, a covered entity must notify each individual whose unsecured PHI has been, or is reasonably believed to have been, breached. (45 C.F.R. § 164.404(a)(1).) Despite the obvious utility of the new harm standard, a few privacy advocates (and four United States congressmen) have expressed displeasure with the new HHS harm standard. An October 1st letter from congressional leaders sent to HHS Secretary Sebelius argues that the ARRA did not imply a harm standard in the breach notification requirements, and requests that HHS repeal the harm standard that was included in the interim final regulations on Breach Notification for Unsecured Protected Health Information. [...] October 12th, 2009 | Tags: ARRA, Computer Security, congress, Democrat, Dingell, harm standard, HIPAA, HITECH, Pallone, rangel, Waxman | Category: HIPAA Security, HITECH Act, Health Reform, Health and Humans Services (HHS), Privacy |
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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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ONC 2nd Annoucement for HIE Grants and a Review of Program Requirements
On March 15, 2010, ONC completed the announcement of State Health Information (State HIE) Exchange Cooperative Agreement Program awardees. The first announcement of awards were on February 12th, 2010. These awards are meant as seed money for State HIE’s which are expected to reach financial independent within 2 to 4 years. The Awardees will be evaluated on various criteria over a four year period. The criteria are detailed in http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10741_888442_0_0_18/FOA_State%20Health%20Information%20Exchange%20Cooperative%20Agreement%20Program_Sept3_updated%20funding%20formula.doc. A PDF of this same document is available here: FOA_State Health Information Exchange Cooperative Agreement Program_Sept3_updated funding formula. Generally, HIEs are intended to transmit healthcare information electronically across organizations within a region, community or hospital system. HIE generally allow for the movement of clinical information among disparate health systems. Various gateways and interface utilities are used to translate data from disparate information [...]