Security breach

The type of alarm system used is dependent on the expected type of security breach and the method employed in responding to one. In unguarded premises, requiring only a low level of security, an alarm that operates immediately a device detects a security breach may be sufficient to ward off vandals, burglars and crimes of opportunity. On the other hand, where breaches of security may involve more determined criminals, such as fraud or industrial espionage, delayed alarms on the premises may give time for security personnel and/or police to apprehend the criminal in the process of committing the crime. 

Security breach. Physical security breaches, such as unsecured doors, open hatches, and unlocked/forced gates, are probably the most common threat warnings. In most cases, the security breach is likely related to lax operations or typical criminal activity such as trespassing, vandalism, and theft. However, it may be prudent to assess any security breach with respect to the possibility of attack. 

Gardner E. System assigns passwords, beeps at security breaches, sidebar. Mod Healthcare 34, Nov. 3, 1989. 

Security incident procedures (all listed implementation features must be present) Implement accurate and current security incident procedures. The reporting of security breaches, so that security violations are reported and handled promptly. Report procedures Response procedures... 

Security management process (all listed implementation features must be present) Creating, administering, and overseeing procedures to ensure the prevention, detection, containment, and correction of security breaches. Risk analysis Risk management Sanction policy Security policy... 

Automation users would like to apply the CII for automating functions that are crucial for them and for society (this is intrinsic to the definition of critical infrastructure ). The functions can be related for example to supply chains, production or financial operations. The positive side is given by the possibility to conduct fast and efficient reactions to unwanted conditions (e.g., unsafe states, security breaches). However this exposes those critical functions to the vulnerabilities and uncertainties of the CII - which can neither ensure the availability of the connection, nor the secure treatment of the data. 

Price Waterhouse Cooper s Information Security Breaches Survey 2002 for the UK Dept, of Trade and Industry states that 44% of UK businesses have suffered at least one malicious security breach in the past year, nearly twice as many as in the 2000 survey 3. 

The conclusion was to add separate clauses into IEC 61508 everywhere where security could have an impact on safety giving advice on how to integrate the security aspect as an additional hazard (risk) for the safety-critical system, i.e., to look at the safety impact of security breaches and then... 

But just as an air crash does not mean the end of commerical aviation, neither does the damage caused by improper use of certain substances mean the end of the chemical industry. The image of chemicals is tarnished, however. Citizens who deliberately risk their own death, when they are not actually killing others, because of speeding on the roads or because they are addicted to alcohol, tobacco, or drugs, are less and less inclined, for all that, to accept accidental security breaches when these are not caused by themselves. 

Procedures and plans supporting business continuity (Disaster Recovery Plans and Contingency Plans) must be specified, tested, and approved before the system is approved for use. Business Continuity Plans will normally be prepared for a business or an operational area rather than for individual computer systems. It is likely that the only way to verify the plan is to walk through a variety of disaster scenarios. Topics for consideration should include catastrophic hardware and software failures, fire/flood/lightning strikes, and security breaches. Alternative means of operation must be available in case of failure if critical data is required at short notice (e.g., in case of drug product recalls). Reference to verification of the Business Continuity Plans is appropriate during OQ/PQ. 

Access denial on demand Security breach attempts... 

Procedures and plans supporting business continuity must be specified, tested, and approved before the system is approved for use. Topics for consideration should include catastrophic hardware and software failures, fire/flood/lightning strikes, and security breaches. Procedures need to address ... 

The implementation of an effective security regime is required to comply with the regulators expectations for control of electronic records. The pharmaceutical manufacturer will be responsible for providing maintenance of the security aspects of LIMS. This is normally accomplished through software protection (e.g., passwords and log-on accounts) but may also take the form of protection through physical restrictions (e.g., locked-up or restricted areas). The management of this function should be in accordance with a formal SOP. The use of passwords and high-level accounts must be strictly controlled to prevent security breaches. Typical examples of control should be ... 

Access rights maintenance Detect and investigate security breaches... 

Logs of creation, deletion, transfers of responsibilities Logs of password renewals, deletions, suspensions Log security breaches Partitioning network... 

For our home-alarm example, potential mistakes fall into two categories False Positives, where the alarm goes off when it s not supposed to, and Failures, where the alarm fails to trigger when a security breach occurs (Exhibit 49.1 ). 

Traceability of goods is crucial in case of the need for product recalls. It will also help to detect theft and fraud. Any discrepancies should be investigated and followed up by appropriate measures to tackle possible security breaches. 

Lack of good security protocols may result in a failure to report lapses in security. Cultural attitudes may result in an acceptance of the failure to report problems. What constitutes a security breach or problem is often not well defined nor widely disseminated. Persons at all levels of the laboratory do not understand what a reportable incident is and how and to whom to report it. 

A training program in laboratory security should set out the expectations of management and the need to maintain a safe and secure laboratory environment. Training should be conducted periodically and especially for new personnel. Laboratories should be inspected routinely for compliance with security measures. Personnel working in laboratories should follow all established security procedures, and there should be a protocol for reporting security breaches or security concerns. 

All security breaches, small or large, need to be reported in writing, to the concerned authorities. That requires an atmosphere of openness and confidence in the rules and in the leaders. Reporting security breaches helps to improve security systems. People who report security breaches immediately should be rewarded. 

Laboratory workers may witness safety or security breaches but be fearful of or apprehensive about confronting coworkers and authorities. These are normal feelings and reactions that should be countered by providing anonymity for informants, if possible, by protecting informants and... 

Maintaining a secure EHR with connection to various ever-changing platforms has proven to be quite expensive and complicated the healthcare provider is fully responsible for any occurrence of a security breach at the provider s office. A current survey [4] estimates that 54% of the EHR users are not satisfied with their system interconnectivity. Furthermore, there is a dismal effect on doctor-patient relationships, with diminished productivity, efficiency, and revenue generation while contending with the high cost of EHR adoption, estimated at 5000- 50,000 per physician. 

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