Medical devices; device tracking. Final rule.
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The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements. (+info)
AMIA advocates national health information system in fight against national health threats.
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To protect public health and national safety, AMIA recommends that the federal government dedicate technologic resources and medical informatics expertise to create a national health information infrastructure (NHII). An NHII provides the underlying information utility that connects local health providers and health officials through high-speed networks to national data systems necessary to detect and track global threats to public health. AMIA strongly recommends the accelerated development and wide-scale deployment of electronic public health surveillance systems, computer-based patient records, and disaster-response information technologies. Such efforts hold the greatest potential to protect our citizens from disaster and to deliver the best health care if disaster strikes. (+info)
Development and validation of a computerized South Asian Names and Group Recognition Algorithm (SANGRA) for use in British health-related studies.
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BACKGROUND: Studies on ethnic variations in health have played an important role in aetiological and health services research. Most routine datasets, however, do not include information on ethnicity. South Asians, one of the largest minority ethnic groups in Britain, have distinctive names that also allow differentiation of the main sub-groups with their important differences in health-related exposures and disease risks. METHODS: A computerized name recognition algorithm (SANGRA) was developed incorporating directories of South Asian first names and surnames together with their religious and linguistic origin. SANGRA was validated using health-related data with self-ascribed information on ethnicity. RESULTS: SANGRA was successful in recognizing South Asian origin in reference datasets, with sensitivity of 89-96 per cent, specificity of 94-98 per cent, positive predictive value (PPV) of 80-89 per cent and negative predictive value (NPV) of 98-99 per cent. Religious origin was correctly assigned in the majority of cases: sensitivity, specificity and PPV were 94 per cent, 91 per cent and 90 per cent for Hindus; 90 per cent, 99 per cent and 98 per cent for Muslims; and 76 per cent, 99 per cent and 94 per cent for Sikhs. SANGRA correctly identified 76 per cent Gujerati and 70 per cent Punjabi names, although only 62 per cent of Gujerati names were sufficiently distinct to be allocated to the Gujerati-only category and only 53 per cent Punjabi names were allocated to the Punjabi-only category. However, specificity and PPV were high for both languages (respectively 97 per cent and 93 per cent for Gujerati, and 99 per cent and 97 per cent for Punjabi). CONCLUSIONS: SANGRA provides a practical and valid method of ascertaining South Asian origin by name and, to a lesser degree of accuracy, of differentiating between the main religious and linguistic subgroups living in Britain. This algorithm will be useful in health-related studies where information on self-ascribed ethnicity is not available or is of a limited nature. (+info)
Patient information extraction in digitized radiography.
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Digital imagery is gradually replacing the traditional radiograph with the development of digital radiography and film scanner. This report presents a new method to extract the patient information number (PIN) field automatically from the film-scanned image using image analysis technique. To evaluate the PIN field extraction algorithm, 2 formats of label acquired from 2 different hospitals are tested. Given the available films with no constraints on the way the labels are written and positioned, the correct extraction rates are 73% and 84%, respectively. This extracted PIN information can link with Radiology Information System (RIS) or Hospital Information System (HIS), and the image scanned from the film then can be filed into the database automatically. The efficiency this method offers can simplify greatly the image filing process and improve the user friendliness of the overall image digitization system. Moreover, compared with the bar code reader, it solves the automatic information input problem in a very economical way. The authors believe the success of this technique will benefit the development of the PACS (Picture Archiving and Communication System) and teleradiology. (+info)
Analysis of identifier performance using a deterministic linkage algorithm.
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As part of developing a record linkage algorithm using de-identified patient data, we analyzed the performance of several demographic variables for making linkages between patient registry records from two hospital registries and the Social Security Death Master File. We analyzed samples from each registry totaling 6,000 record-pairs to establish a linkage gold-standard. Using Social Security Number as the exclusive linkage variable resulted in substantial linkage error rates of 4.7% and 9.2%. The best single variable combination for finding links was Social Security Number, phonetically compressed first name, birth month, and gender. This found 87% and 88% of the links without any false links. We achieved sensitivities of 90% to 92% while maintaining 100% specificity using combinations of social security number, gender, name, and birth date fields. This represents an accurate method for linking patient records to death data and is the basis for a more generalized de-identified linkage algorithm. (+info)
Claimant identification pilot projects. Final rules.
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We are revising our regulations that pertain to the processing of initial claims for disability benefits under title II (Social Security Disability Insurance) and title XVI (Supplemental Security Income) of the Social Security Act (the Act). We will be conducting pilot projects wherein we will request photographic identification from individuals filing for title II and title XVI disability and blindness benefits in specified geographic areas covered by the pilot projects. In addition, we will require individuals to allow us to take their photograph and we will make these photographs a part of the claims folder. We will permit an exception to the photograph requirement when an individual has a sincere religious objection. This process will strengthen the integrity of the disability claims process by helping to ensure that the individual filing the application is the same individual examined by the consultative examination (CE) physician. (+info)
Operating on patients wearing personal identity devices: a report of two cases.
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We report on two patients who have recently required emergency surgery and who were wearing personal identity devices at the time of presentation. The devices bear a telephone number and a message stating that, if found, the management company should be informed of the whereabouts of their owner. We discuss the issues relating to the disclosure of information to a third party in this situation and whether there is any legal obligation to do so. The conclusion of a review of the relevant literature is that the only reason to divulge information to a third party would be if a patient posed a serious risk of death or serious harm to another party. In the majority of foreseeable circumstances, this would not be the case. (+info)
What is a Caldicott guardian?
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A review of patient confidentiality issues was commissioned and its findings published as the Caldicott Report in December 1997. It made 16 recommendations and formulated six principals. To help in remembering these principles the mnemonic FIONA C can be used: Formal justification of purpose; Information transferred only when absolutely necessary; Only the minimum required; Need to know access controls; All to understand their responsibilities; Comply with and understand the law. Since the Caldicott Report in 1997 the following acts have become law. Data Protection Act 1998, Human Rights Act 1998, Public Interest Disclosure Act 1998, Audit Commission Act 1998, Terrorism Act 2000, section 60 of the Health and Social Care Act 2001 and Regulation of Investigatory Powers Act 2000, and by 2005 The Freedom of Information Act 2000 will become law and affect the NHS. Consequently it can be seen that the role and responsibility of Caldicott guardians has grown significantly into what is now known as information governance. (+info)