Showing posts with label disclosure. Show all posts
Showing posts with label disclosure. Show all posts

Wednesday, November 10, 2010

Mercy Health Plan's Medical Data Security Breach Should Inform OCR's Harm Standard

A recent medical data security breach occurring in Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan in Philadelphia lends support to removing the harm threshold written into the Interim Final Rule of HIPAA and the HITECH Act before promulgating the Final Rule. In August of 2009, the Office of Civil Rights (OCR) published the Interim Final Rule with request for comments on breach notification of protected health information (PHI), which set forth additional definitions and standards to relating to the Privacy Section. OCR is expected to issue the Final Rule by the end of this year or early next year.

When OCR published the Interim Final Rule last year, the media jumped on the inclusion of instructing the covered entity responsible for a breach of PHI to perform a risk assessment as a deciding factor of whether or not to disclose the breach to the individuals and the Department of Health and Human Services (HHS). Eight members of Congress expressed their concern by writing a letter to Kathleen Sebelius, noting that the American Recovery and Reinvestment Act (ARRA) that sets forth the statutory mandates relating to privacy of PHI does not include nor imply a harm standard and urged HHS to repeal or revise the harm threshold standard.

Section 13402 of the ARRA states that health care entities must notify the individual when there is an “unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of that information.” In order to decide whether a breach compromises the individual’s security or privacy, the Interim Final Rule set forth a risk assessment criteria and translated a “compromise” of security or privacy to mean a “significant risk of financial, reputational, or other harm” to the individual. Problematically, the covered entity is tasked with assessing the risk of harm to determine whether it meets the threshold for disclosing the breach to the individual and HHS. The Interim Final Rule states that the covered entity should consider to whom the information was disclosed, the type and amount of information, and whether the information contained materials relating to potentially stigmatizing health conditions.

The letter written on behalf of eight Congressional representatives clarified that Congress specifically excluded a threshold for harm when promulgating Section 13402. Furthermore, requiring mandatory disclosure serves as a powerful incentive to health care entities to enact strict privacy and security protections to decrease the likelihood of a breach even occurring.

The Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan (MHP) incident is only the latest in a long line of PHI breaches. In late October, the Philadelphia Inquirer reported that a computer flash drive belonging to Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan (MPH) was lost at a community health fair. The flash drive contained the medical record information of over 280,000 Pennsylvanian Medicaid recipients.

Donna Burtanger, Vice President of Communications at MHP, stated that company representatives were trying to use the health plan members’ PHI to personalize service at community health fairs. Burtanger offered the example of when a health plan member visits a church sponsored health fair, the insurance company representative can access the member’s medical record to schedule an appropriate screening test such as a mammogram.

As one article pointed out, MHP assumes that the patients under the plan would want company employees to have and access the patient’s full medical record or bring that sensitive health information into a less secure location such as a community health fair. This situation highlighted the vast discrepancy between how an insurance company and its members would view the risk-benefit calculation of permitting non-essential access of their sensitive medical information.

If a health insurance company such as MHP does not know when its members would not want their information shared, accessed, or transported, it likely would also face a disconnect when attempting to determine potential harm arising from a breach of its members’ PHI and whether that level of harm would require disclosure of the breach.

OCR should consider whether placing a level of discretion in the hands of health care entities given the knowledge of this difference will build the public’s trust of using electronic health information.


--Katherine Drabiak-Syed

Friday, April 25, 2008

Disclosing Risk: Good Communication or "Doctor-Knows-Best"?

A newly published paper from PredictER's Peter H. Schwartz and Eric M. Meslin, examines the challenges of balancing beneficence and the respect for autonomy in preventive and predictive medicine. In "The ethics of information: absolute risk reduction and patient understanding of screening" (J Gen Intern Med. 2008 Apr 18; [Epub ahead of print] | PMID: 18421509) the authors question whether providing absolute probabilities of risk based, for example, on genetic screening for breast cancer, is always in the best interest of the patient's health. While many argue the respect for the patient's autonomy demands that risk is communicated numerically or graphically, Schwartz and Meslin argue that the disclosures should be made "in the light of careful consideration of patient understanding and possible impacts on uptake and well-being".

Friday, February 15, 2008

Sharing Patient Health Records: Wisconsin Assembly Bill 793

On February 11 legislators in Wisconsin introduced Assembly Bill 793 [PDF – 25.7 KB], which proposes to reduce restrictions on redisclosures of patient health records in particular circumstances to facilitate electronic sharing of information. Wisconsin’s current law (WI ST 51.30) closely follows requirements set forth in HIPAA such as allowing the patient to authorize the disclosure of health records only after the patient is informed of the following: to whom the records will be sent, for what purpose will they be disclosed, and for what length of time the authorization is effective. The current law also requires recording what records are released and to whom they are released, creating a documentation trail.

AB 793 Section 10(b) would modify these restrictions and allow a covered entity to redisclose a patient’s health care record for a purpose for which a release is “otherwise permitted,” such as: if a patient previously has agreed to its release [see Section 9(4)(b)(1)]. Non-covered entities may redisclose [per Section 10(c)] the patient’s record subject to more qualifications, such as redisclosure for a purpose for which the patient health care record was initially received. Read in conjunction with Section 10(c), Section 10(b) would allow a covered entity to redisclose a patient’s health record in more circumstances without that patient’s consent.

As reported by the Wisconsin Technology Network, the Wisconsin Department of Health and Family Services (WDHFS) Secretary, Kevin Hayden, maintains that AB 793 does not apply to disclosures covered under HIPAA. In general, HIPAA requires a patient to consent to the release of protected health information for treatment purposes by the receiving hospital and would extend this release, for example, if the patient is transferred for continuing treatment (45 CFR 164.502). Compiling and transferring patient records for other purposes (such as research or database compilation) not related to the patient’s treatment plan or administrative health care operations generally requires a patient authorization. A valid authorization (45 CFR 164.508) contains, among other elements: to whom the information will be disclosed, the purpose of the disclosure, and the individual’s right to revoke the authorization.

If the purpose of HIPAA is read to limit the release of patient records with exceptions to facilitate present treatment, then in most instances medical records must be explicitly released by the patient for use by other individuals by means of an authorization. If the patient does authorize additional use of his records, HIPAA envisions that the patient can track the release of that record with some accountability. WDHFS seems to modify how they interpret HIPAA’s requirements as AB 793 would eliminate the requirement to obtain consent to disclose the patient’s record as well as eliminating documentation of these disclosures.

It is uncertain how WDHFS and the drafters of AB 793 are interpreting HIPAA coverage, whether their interpretation relies on assuming a patient’s singular consent is sufficient, or they plan to add measures to ensure compliance if the bill is implemented. Do they contemplate “treatment” in terms of all foreseeable future treatment? Is this framework something more state legislatures should adopt to increase the ability to retrieve patient records?

If WDHFS’s further discussion of AB 793 does in fact comply with HIPAA’s requirements, this move toward compiling health records could increase the efficiency of health care for the state’s residents. In order to ensure compliance, WDHFS may need to place additional restrictions to their records system or change the substance of patients’ initial consent. - Katherine Drabiak

Tuesday, July 31, 2007

Web 2.0 + Medicine = Medicine 2.0: Featured Blogs

ScienceRoll and Medicine 2.0

Readers interested in casual discussions on the future of medicine at the cross-roads of genetics research, electronic medical records, and the internet will find plenty to read in recent blog entries using the terms "Medicine 2.0" or "Health 2.0". Advocates of the subject, include Bertalan Meskó, a medical student at the University of Debrecen (Hungary). Meskó, who monitors and writes about the topic in his blog ScienceRoll, holds that "the new generation of web services, will [play] (and already is playing) ... an important role in the future of medicine. These web tools, expert-based community sites, medical blogs and wikis can ease the work of physicians, scientists, medical students [and] ... medical librarians". In addition to regular posts on his blog, Meskó also edits a weekly blog carnival (an index or review of blog entries) on the subject, entitled Medicine 2.0. Mesko's ScienceRoll also contributes entries on genomics, clinical genetics, genetic testing, and personalized medicine.

"Medical Ethics 2.0"

Science Roll, July 19, 2007
and Medicine 2.0, hosted recently by J.C. Jones at HealthLine Connect were among several blogs citing "Medical Ethics 2.0", published July 16th by Jason Bobe at The Personal Genome . [Others citing Bobe include: Philosophy and Bioethics and The CEP Library.] Bobe discusses the possibility that future users of online genealogy services may begin to add medical information to their family trees. Following his review of the BMJ “Head-to-Head” feature: “Should families own genetic information?” [BMJ 2007;335:22 (7 July), doi:10.1136/bmj.39252.386030], he questions how user-generated genetic information and Web 2.0 technologies would complicate the ethical problems of privacy and disclosure.

Medical Ethics 3.0?

In "Health care eyes Web 3.0" (Government Health IT, 16 July 2006
), Brian Robinson reports on developing Semantic Web technologies and their anticipated impact on the medical formatics and health care provision. The Semantic Web uses Resource Description Framework (RDF), Web Ontology Language, and other ontologies to "ascribe meaning to data depending on the context in which it is used". The Semantic Web is expected to provide, for example, the ability to "identify data related to age, weight and diseases, and ... then deliver that data based on the context of a query". Projects in development include: rules-based diagnostic decision-support systems for Partners HealthCare System (Boston) and a public health surveillance system under the direction of Parsa Mirhaji at the University of Texas Health Science Center at Houston.

In addition to Mirhaji, comments are provided from Dean Giustini (Biomedical Branch Library, University of British Columbia), Vipul Kashyap (Partners HealthCare), and Bob Shimp (Oracle's Global Technology Business Unit). The story does not, however, explore the social and ethical implications of the Semantic Web for medical research.

Thursday, July 12, 2007

Research: Communicating Genetic Information; Event: CDC--Translational Genetic Research

In the Literature: Communicating Genetic Information

Gaff, CL, et al. Process and outcome in communication of genetic information within families: a systematic review. European Journal of Human Genetics. [advance online publication 4 July 2007]; doi: 10.1038/sj.ejhg.5201883. http://www.nature.com/ejhg/journal/vaop/ncurrent/abs/5201883a.html

. . . . To understand the process by which communication occurs as well as its outcomes, a systematic review of actual communication in families about genetic risk was conducted. Findings from 29 papers meeting the inclusion criteria were summarised and are presented narratively. . . .

Gilbar, R. Communicating genetic information in the family: the familial relationship as the forgotten factor. Journal of Medical Ethics 33 (7), 390-3 (Jul 2007). pmid/17601865; doi/10.1136/jme.2006.017467. http://jme.bmj.com/cgi/content/abstract/33/7/390

. . . . Based on a legal and bioethical analysis on the one hand, and an examination of empirical studies on the other, this paper advocates the adoption of a relational perception of autonomy, which, in the context of genetics, takes into account the effect that any decision-whether to disclose or not to disclose-will have on the familial relationship and the dynamics of the particular family. . . .

Seminar Announced: “Closing the Gap Between Human Genome Discoveries and Population Health”. CDC Genomics, July 26, 2007.

Public Health Genomics Seminar Series: Closing the Gap Between Human Genome Discoveries and Population Health. http://www.cdc.gov/genomics/events/special1.htm

Session 6: But how do we translate new genetic knowledge into practice? 1-3 pm, ENVISION-Koger Center, Williams Bld, Room 1802/05. Centers for Disase Control and Prevention.

"How do we actually translate guidelines into action?" – Speaker: Jon Kerner, NCI
"What is the role of professional organizations, consumers, oversight and regulation?" -- Speaker: Kathy Hudson, Genetics and Public Policy Center, Johns Hopkins University.


[PredictER Note: Slides and video-casts will be posted following the event.]