Medical records, storing

Existing data sources, preferably electronically stored, such as electronic ambulatory medical records, emergency department data, pharmacy records, school absentee data and other data sets covering large populations... 

Storing medical records. Where questions are raised about the management of individual patients, computerized databases can be used to quickly access records. An information system can also allow more than one staff member to access records at the same time. 

It is important to establish and agree on ownership of laboratory specimens, X rays, and medical records on who is to store them and for how long and on who may have access to them in the future. It may be desirable for the voucher agency to retain intellectual property rights of all data for all studies and publications. Patient confidentiality must be respected at all times, but the voucher agency may want to request access to medical records for supervision or study purposes. If the voucher scheme incorporates a research component involving human subjects, it is essential to obtain approval from the appropriate bodies and, if necessary, informed consent from the patients. 

Computers similar to those developed to control the flight plans of the Apollo capsule were used to store, process, and cross-check medical records, to monitor patient status in intensive care units, and to provide sophisticated statistical diagnoses of potential diseases correlated with specific sets of patient symptoms. 

To address these issues with paper-based medical records, there has long been a vision to store an entire medical record, or any part of it, electronically so that a paper-based chart... 

At the heart of any EMR system are data sets or databases that organize, store, and secure the vast amount of medical records. A data model is the framework in which these records are organized. The most popular industrial database systems are relational, and the prominent data models are entity-relationship diagrams or relational models. However, to be... 

The disadvantages of paper medical records filed in private clinics or hospital store rooms have been discussed many times, but those systems do not pretend to be PHRs. The paper records kept by patients in Vietnam, parts of Africa, or Sarawak (East Malaysia) are still not quite ubiquitous. Data entry is by healthcare workers during meetings with the patients, so it is episodic and not ubiquitous in time. The records are accessible wherever the patient is (or has them) but not by anyone remote from the patient, so they are not ubiquitous in location. 

This last point is very important in two ways. First, throughout this book, the importance of optimum quality data is emphasized many times. In most cases, this comment is associated with acquiring the data, for example, measuring blood pressure as accurately as possible. However, since all of these data are entered into databases, data entry must be accurate A correct measurement that is stored incorrectly immediately lessens the quality of the overall data. Sometimes data are transferred from a measurement device electronically to the database, and sometimes data are manually entered into the database. Procedures to ensure accuracy, correctness, and completeness of data transfer are an essential part of data recording and management. Second, the storage of sensitive data (personal, medical) and proprietary data requires additional considerations to ensure that these data do not become accessible and available to unauthorized users. 

Part 11 defines records management as the creation, signing, modification, storage, access, and retrieval of records and the software and hardware platforms used in these processes. This regulation applies to any documentation required by an FDA predicate rule. The Authorities cited for the rule are Secs. 201-903 of the Federal Food, Drug, and Cosmetic Act (21U.S.C. 321-393) Sec. 351 of the Public Health Service Act (42 U.S.C. 262)]. For example, 21 CRF 820.70 requires documentation of process and production controls in quality systems for medical devices. This is a predicate rule. If any of this documentation is created, signed, modified, stored, accessed, or retrieved electronically, the requirements of... 

Conduct an inventory and account for study medications/devices and arrange for extra supplies, including other items, such as CRFs, blank forms and so on, if necessary. Resolve discrepancies between inventory and accountability records, and medication/device use, as recorded in the CRFs. If a pharmacy is involved in the study, the pharmacy and pharmacist must be visited. Check that the medication/device is being dispensed in accordance with the protocol. Check that the medication/device is being stored under appropriate environmental conditions and that the expiry dates are still valid. Check that the medication/device is securely stored in a separate area that is not accessible to individuals not involved in the study. Check that any supplies shipped to the site since the last visit were received in good condition and are properly stored. 

A record cannot reside forever in a big computer, however. For support of mobile medical service, selected health records may need to be collectively copied onto a handheld system. All the sensitive information copied or replicated onto a portable system need to be stored encrypted, and the copy/replication event will be digitally signed or logged in the system for nonrepudiation and... 

We may also recall that there is a further problem in that the data are, in general, highly sensitive and thus fully protected. To address the security requirements and to comply with the legislation for protection of personal privacy, certain personal information must be kept at the initial collection point in the original medium and is prohibited from being copied to or stored in another medium at another location. This was the reason why many workers in medical IT believed that the personal lifetime health record needs to be dynamically assembled out of the information retrieved on demand from various sources. 

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