Anonymized records

For such purpose one might consider an ARC, that is, archive of anonymous record contributions. Such an archive would essentially mirror contributed records, except for being anonymized (see the next chapter). However, fairly sophisticated software would need to be used to serve as gatekeeper between the identified and anonymized archives. Moreover such sophistication will need to extend to police the gates between the ARC and the researchers so that no researcher opens a means of threading back to identify the patient. That is, unless a patient required that he or she be warned of freshly identified medical risks, a process that itself can involve complex security so that outsiders cannot intervene in or reproduce the tracking back mechanism. 

Surprisingly, HIPAA rule permits a covered entity (a person) to have access to health information for research purposes, without obtaining an authorization or documentation of a waiver or an alteration of authorization, to use and disclose PHI included in a limited data set. A covered entity may use and disclose a limited data set for research activities conducted by the covered entity itself, another covered entity, or a researcher who is not a covered entity if the disclosing covered entity and the limited data set recipient enter into a data use agreement. Limited data sets may be used or disclosed only for purposes of research, public health, or healthcare operations. Should the patient find this objectionable, it may be possible to formulate reform such that a patient still contribute anonymized records to an archive of Anonymous Record Contributions (see Chapter 5) ... 

Electronic health record + genomic, lifestyle, etc. —> Anonymous record ... 

Anonymous, How to Prevent Runaway Reactions, EPA 550-F99-004, U.S. Environmental Protection Agency Office of Solid Waste and Emergency Response, August 1999. In addition to the accidents mentioned in the reference, a significant number occurred prior to the 1989 time frame. Serious incidents arc recorded as early as 1957. Accident recording before 1957 was incomplete. 

With electronic medical records, multiple clinical records for the same patient may be treated as belonging to different patients during anonymization and migration of electronic medical records, tainting analytical conclusions. This problem may be difficult to untangle once the anonymized data migration takes place. 

Informed Consent. This must be obtained from study participants in writing before any study-related activities are performed. Regulations clearly describe the required elements of the consent document and the consent process to be followed. A good informed consent process can help ensure that potential subjects understand the nature of the studies they will enter, the type of treatments they will undergo, alternative therapies currently available, and any particular hazards they might experience. They must be informed that they can withdraw from the study at any time without penalty. Subjects are to be asked for their consent to release information from their medical records and told that the medical information may be inspected by sponsor company and regulatory agency representatives. They are to be informed that the results of the trials may be used publicly, but anonymously. 

From a regulatory standpoint, it was emphasized that data to be used for registrational purposes require an audit trail back to the medical record, as is standard for all other data submitted for this purpose. Anonymous or anonymized data14 are not auditable and would not be appropriate for registrational use. 

Information collected to be forwarded to the research team for analysis. To ensure anonymity a unique identifier number to be allocated to each client. Returned needles/syringes to be counted and recorded by staff. A 100 per cent return rate should be aimed for, but it is recognised that this may not always be achievable. 

The use of anonymous control sera will be referred to as fictitious patient controls, since the staff are given no indication that they differ in any way from other samples in a batch. Even with AutoAnalyzers it is possible to include bias in the handling of samples known to be particularly important (e.g., care in the correct identification and reading of the relevant peak on a chart record), and this danger of bias influencing the results for control sera applies much more to manually performed methods. Fictitious patient controls overcome this tendency to bias, but it would be much more difficult to introduce them with equal certainty of anonymity into a laboratory with a small workload. 

There are several kinds of control which can be applied. Of these, be-tween-batch controls making use of materials which can be taken through the entire analytical procedure provide the most valuable single method and must be regarded as essential. Other forms of control (e.g., within-batch controls) can provide useful additional information that helps to delineate the cause of a breakdown in a hitherto satisfactory record of quality control. Whenever possible, controls should be introduced anonymously into the laboratory s work (fictitious patient controls. Section 3.1.3). Types of control materials for analyses on plasma or serum which have been discussed include ... 

Another important aspect of authentication is documentation of the chain of custody of an artifact. An artifact that has a clearly documented history that goes back to the artifact s discovery in a carefully excavated or recorded context lends much more credibility to authenticity than does an artifact recently marketed by an anonymous collector. For example, the Archaic Mark first appeared at the University of Chicago in 1937 and the known provenience of the Shroud of Turin can only be traced back to 1357. 

Still, billing-related records carry well-worked out classification codes for diseases and treatments represented in standards, such as ICD-9-CM volume 1 and 2 as the code set for diagnosis codes, ICD-9-CM volume 3 for inpatient hospital services, CDT for dental services, and NDC codes for drugs. This is enough form to obtain knowledge for the common good on analysis of patient data. Pharmaceutical companies, FDA, and medical researchers have already started to access and analyze the anonymized form of these data. 

The Right to Privacy and Dignity. .. and Access. The patient has the right to all the information in his or her medical record. .., but data-mined records for research must be anonymous. 

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