A Model Regime of Privacy Protection (Version 2.0)

This version incorporates and responds to the many comments that we received to Version 1.1, which we released on March 10, 2005. Privacy protection in the United States has often been criticized, but critics have too infrequently suggested specific proposals for reform. Recently, there has been significant legislative interest at both the federal and state levels in addressing the privacy of personal information. This was sparked when ChoicePoint, one of the largest data brokers in the United States with records on almost every adult American citizen, sold data on about 145,000 people to fraudulent businesses set up by identity thieves. Other companies announced security breaches, including LexisNexis, from which personal information about 32,000 people was improperly accessed. Senator Schumer criticized Westlaw for making available to certain subscribers personal information including Social Security Numbers (SSNs). In the aftermath of the ChoicePoint debacle and other major information security breaches, both of us have been asked by Congressional legislative staffers, state legislative policymakers, journalists, academics, and others about what specifically should be done to better regulate information privacy. In response to these questions, we believe that it is imperative to have a discussion of concrete legislative solutions to privacy problems. What appears below is our attempt at such an endeavor. Privacy experts have long suggested that information collection be consistent with Fair Information Practices. This Model Regime incorporates many of those practices and applies them specifically to the context of commercial data brokers such as ChoicePoint. We hope that this will provide useful guidance to legislators and policymakers in crafting laws and regulations. We also intend this to be a work-in-progress in which we collaborate with others. We have welcomed input from other academics, policymakers, journalists, and experts as well as from the industries and businesses that will be subject to the regulations we propose. We have incorporated criticisms and constructive suggestions, and we will continue to update this Model Regime to include the comments we find most helpful and illuminating. Notice, Consent, Control, and Access 1. Universal Notice 2. Meaningful Informed Consent 3. One-Step Exercise of Rights 4. Individual Credit Management 5. Access to and Accuracy of Personal Information Security of Personal Information 6. Secure Identification 7. Disclosure of Security Breaches Business Access to and Use of Personal Information 8. Social Security Number Use Limitation 9. Access and Use Restrictions for Public Records 10. Curbing Excessive Uses of Background Checks 11. Private Investigators Government Access to and Use of Personal Data 12. Limiting Government Access to Business and Financial Records 13. Government Data Mining 14. Control of Government Maintenance of Personal Information Privacy Innovation and Enforcement 15. Preserving the Innovative Role of the States 16. Effective Enforcement of Privacy Rights Commentar

A Model Regime of Privacy Protection (Version 2.0)

This version incorporates and responds to the many comments that we received to Version 1.1, which we released on March 10, 2005. Privacy protection in the United States has often been criticized, but critics have too infrequently suggested specific proposals for reform. Recently, there has been significant legislative interest at both the federal and state levels in addressing the privacy of personal information. This was sparked when ChoicePoint, one of the largest data brokers in the United States with records on almost every adult American citizen, sold data on about 145,000 people to fraudulent businesses set up by identity thieves. Other companies announced security breaches, including LexisNexis, from which personal information about 32,000 people was improperly accessed. Senator Schumer criticized Westlaw for making available to certain subscribers personal information including Social Security Numbers (SSNs). In the aftermath of the ChoicePoint debacle and other major information security breaches, both of us have been asked by Congressional legislative staffers, state legislative policymakers, journalists, academics, and others about what specifically should be done to better regulate information privacy. In response to these questions, we believe that it is imperative to have a discussion of concrete legislative solutions to privacy problems. What appears below is our attempt at such an endeavor. Privacy experts have long suggested that information collection be consistent with Fair Information Practices. This Model Regime incorporates many of those practices and applies them specifically to the context of commercial data brokers such as ChoicePoint. We hope that this will provide useful guidance to legislators and policymakers in crafting laws and regulations. We also intend this to be a work-in-progress in which we collaborate with others. We have welcomed input from other academics, policymakers, journalists, and experts as well as from the industries and businesses that will be subject to the regulations we propose. We have incorporated criticisms and constructive suggestions, and we will continue to update this Model Regime to include the comments we find most helpful and illuminating. Notice, Consent, Control, and Access 1. Universal Notice 2. Meaningful Informed Consent 3. One-Step Exercise of Rights 4. Individual Credit Management 5. Access to and Accuracy of Personal Information Security of Personal Information 6. Secure Identification 7. Disclosure of Security Breaches Business Access to and Use of Personal Information 8. Social Security Number Use Limitation 9. Access and Use Restrictions for Public Records 10. Curbing Excessive Uses of Background Checks 11. Private Investigators Government Access to and Use of Personal Data 12. Limiting Government Access to Business and Financial Records 13. Government Data Mining 14. Control of Government Maintenance of Personal Information Privacy Innovation and Enforcement 15. Preserving the Innovative Role of the States 16. Effective Enforcement of Privacy Rights Commentar

When REBOA grows wings: Resuscitative endovascular balloon occlusion of the aorta to facilitate aeromedical transport

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a helpful adjunct in the control of non-compressible truncal hemorrhage. Concerns regarding ischemia time limits its applicability in transfer. We describe the first reported case of civilian transfer via aeromedical transport to a higher level of care with a zone 3 REBOA catheter deployed. CASE REPORT: We present the case of a patient in hemorrhagic shock with a complex pelvic fracture exceeding the capability of a rural level-two trauma center requiring the use of REBOA catheter to permit aeromedical transport to a level-one trauma center for definitive embolization. CONCLUSION: Deployment of REBOA catheter to facilitate aeromedical transport to an appropriate level of care may be considered if travel times can be kept brief and there is a process and training in place to empower flight medics to consider transporting with a REBOA deployed

Spectrum of statin hepatotoxicity: Experience of the drug‐induced liver injury network

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/108111/1/hep27157.pd

Copyright & Privacy - Through the Political Lens, 4 J. Marshall Rev. Intell. Prop. L. 306 (2005)

Veteran beltway players discuss the politics of P2P technology and Privacy. How far can or should Congress go? Can the United States export its values or its laws in this area? Are content owners in a losing Luddite struggle? What is the role of litigators, lobbyists and legislators in this war

Calibrating from Within: Multipoint Internal Calibration of a Quantitative Mass Spectrometric Assay of Serum Methotrexate.

BACKGROUND:Clinical LC-MS/MS assays traditionally require that samples be run in batches with calibration curves in each batch. This approach is inefficient and presents a barrier to random access analysis. We developed an alternative approach called multipoint internal calibration (MPIC) that eliminated the need for batch-mode analysis. METHODS:The new approach used 4 variants of 13C-labeled methotrexate (0.026-10.3 µM) as an internal calibration curve within each sample. One site carried out a comprehensive validation, which included an evaluation of interferences and matrix effects, lower limit of quantification (LLOQ), and 20-day precision. Three sites evaluated assay precision and linearity. MPIC was also compared with traditional LC-MS/MS and an immunoassay. RESULTS:Recovery of spiked analyte was 93%-102%. The LLOQ was validated to be 0.017 µM. Total variability, determined in a 20-day experiment, was 11.5%CV. In a 5-day variability study performed at each site, total imprecision was 3.4 to 16.8%CV. Linearity was validated throughout the calibrator range (r2 > 0.995, slopes = 0.996-1.01). In comparing 40 samples run in each laboratory, the median interlaboratory imprecision was 6.55%CV. MPIC quantification was comparable to both traditional LC-MS/MS and immunoassay (r2 = 0.96-0.98, slopes = 1.04-1.06). Bland-Altman analysis of all comparisons showed biases rarely exceeding 20% when MTX concentrations were >0.4 µM. CONCLUSION:The MPIC method for serum methotrexate quantification was validated in a multisite proof-of-concept study and represents a big step toward random-access LC-MS/MS analysis, which could change the paradigm of mass spectrometry in the clinical laboratory

Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug‐Induced Liver Injury Network (DILIN)

Background & AimsBecause of the lack of objective tests to diagnose drug‐induced liver injury (DILI), causality assessment is a matter of debate. Expert opinion is often used in research and industry, but its test–retest reliability is unknown. To determine the test–retest reliability of the expert opinion process used by the Drug‐Induced Liver Injury Network (DILIN).MethodsThree DILIN hepatologists adjudicate suspected hepatotoxicity cases to one of five categories representing levels of likelihood of DILI. Adjudication is based on retrospective assessment of gathered case data that include prospective follow‐up information. One hundred randomly selected DILIN cases were re‐assessed using the same processes for initial assessment but by three different reviewers in 92% of cases.ResultsThe median time between assessments was 938 days (range 140–2352). Thirty‐one cases involved >1 agent. Weighted kappa statistics for overall case and individual agent category agreement were 0.60 (95% CI: 0.50–0.71) and 0.60 (0.52–0.68) respectively. Overall case adjudications were within one category of each other 93% of the time, while 5% differed by two categories and 2% differed by three categories. Fourteen per cent crossed the 50% threshold of likelihood owing to competing diagnoses or atypical timing between drug exposure and injury.ConclusionsThe DILIN expert opinion causality assessment method has moderate interobserver reliability but very good agreement within one category. A small but important proportion of cases could not be reliably diagnosed as ≥50% likely to be DILI.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/111130/1/liv12540.pd

Fatigue in Patients with Chronic Hepatitis B Living in North America: Results from the Hepatitis B Research Network (HBRN)

Fatigue is a common symptom of liver disease but not well-characterized in patients with chronic hepatitis B virus (HBV)

Under-reporting and Poor Adherence to Monitoring Guidelines for Severe Cases of Isoniazid Hepatotoxicity

IMPORTANCE: Mutations in known causal Alzheimer disease (AD) genes account for only 1% to 3% of patients and almost all are dominantly inherited. Recessive inheritance of complex phenotypes can be linked to long (>1-megabase [Mb]) runs of homozygosity (ROHs) detectable by single-nucleotide polymorphism (SNP) arrays. OBJECTIVE: To evaluate the association between ROHs and AD in an African American population known to have a risk for AD up to 3 times higher than white individuals. DESIGN, SETTING, AND PARTICIPANTS: Case-control study of a large African American data set previously genotyped on different genome-wide SNP arrays conducted from December 2013 to January 2015. Global and locus-based ROH measurements were analyzed using raw or imputed genotype data. We studied the raw genotypes from 2 case-control subsets grouped based on SNP array: Alzheimer's Disease Genetics Consortium data set (871 cases and 1620 control individuals) and Chicago Health and Aging Project-Indianapolis Ibadan Dementia Study data set (279 cases and 1367 control individuals). We then examined the entire data set using imputed genotypes from 1917 cases and 3858 control individuals. MAIN OUTCOMES AND MEASURES: The ROHs larger than 1 Mb, 2 Mb, or 3 Mb were investigated separately for global burden evaluation, consensus regions, and gene-based analyses. RESULTS: The African American cohort had a low degree of inbreeding (F ~ 0.006). In the Alzheimer's Disease Genetics Consortium data set, we detected a significantly higher proportion of cases with ROHs greater than 2 Mb (P = .004) or greater than 3 Mb (P = .02), as well as a significant 114-kilobase consensus region on chr4q31.3 (empirical P value 2 = .04; ROHs >2 Mb). In the Chicago Health and Aging Project-Indianapolis Ibadan Dementia Study data set, we identified a significant 202-kilobase consensus region on Chr15q24.1 (empirical P value 2 = .02; ROHs >1 Mb) and a cluster of 13 significant genes on Chr3p21.31 (empirical P value 2 = .03; ROHs >3 Mb). A total of 43 of 49 nominally significant genes common for both data sets also mapped to Chr3p21.31. Analyses of imputed SNP data from the entire data set confirmed the association of AD with global ROH measurements (12.38 ROHs >1 Mb in cases vs 12.11 in controls; 2.986 Mb average size of ROHs >2 Mb in cases vs 2.889 Mb in controls; and 22% of cases with ROHs >3 Mb vs 19% of controls) and a gene-cluster on Chr3p21.31 (empirical P value 2 = .006-.04; ROHs >3 Mb). Also, we detected a significant association between AD and CLDN17 (empirical P value 2 = .01; ROHs >1 Mb), encoding a protein from the Claudin family, members of which were previously suggested as AD biomarkers. CONCLUSIONS AND RELEVANCE: To our knowledge, we discovered the first evidence of increased burden of ROHs among patients with AD from an outbred African American population, which could reflect either the cumulative effect of multiple ROHs to AD or the contribution of specific loci harboring recessive mutations and risk haplotypes in a subset of patients. Sequencing is required to uncover AD variants in these individuals