place. a contingency plan should be in place for responding to emergencies. covered entities are responsible for backing up their data and having disaster recovery procedures in place. the plan should document data priority and failure analysis, testing activities, and change control procedures. internal audits play a key role in hipaa compliance by reviewing operations with the goal of identifying potential security violations. policies and procedures should specifically document the scope, frequency, and procedures of audits. audits should be both routine and event-based. procedures should document instructions for addressing and responding to security breaches that are identified either during the audit or the normal course of operations. physical safeguards – controlling physical access to protect against inappropriate access to protected data controls must govern the introduction and removal of hardware and software from the network. (when equipment is retired it must be disposed of properly to ensure that phi is not compromised.) access to equipment containing health information should be carefully controlled and monitored. access to hardware and software must be limited to properly authorized individuals. required access controls consist of facility security plans, maintenance records, and visitor sign-in and escorts. policies are required to address proper workstation use. workstations should be removed from high traffic areas and monitor screens should not be in direct view of the public. if the covered entities utilize contractors or agents, they too must be fully trained on their physical access responsibilities. technical safeguards – controlling access to computer systems and enabling covered entities to protect communications containing phi transmitted electronically over open networks from being intercepted by anyone other than the intended recipient. information systems housing phi must be protected from intrusion. when information flows over open networks, some form of encryption must be utilized. if closed systems/networks are utilized, existing access controls are considered sufficient and encryption is optional. each covered entity is responsible for ensuring that the data within its systems has not been changed or erased in an unauthorized manner. data corroboration, including the use of a checksum, double-keying, message authentication, and digital signature may be used to ensure data integrity. covered entities must also authenticate entities with which they communicate. authentication consists of corroborating that an entity is who it claims to be. examples of corroboration include password systems, two or three-way handshakes, telephone callback, and token systems. covered entities must make documentation of their hipaa practices available to the government to determine compliance. in addition to policies and procedures and access records, information technology documentation should also include a written record of all configuration settings on the components of the network because these components are complex, configurable, and always changing. documented risk analysis and risk management programs are required. covered entities must carefully consider the risks of their operations as they implement systems to comply with the act. (the requirement of risk analysis and risk management implies that the act's security requirements are a minimum standard and places responsibility on covered entities to take all reasonable precautions necessary to prevent phi from being used for non-health purposes.) unique identifiers rule (national provider identifier) hipaa covered entities such as providers completing electronic transactions, healthcare clearinghouses, and large health plans must use only the national provider identifier (npi) to identify covered healthcare providers in standard transactions by may 23, 2007. small health plans must use only the npi by may 23, 2008. effective from may 2006 (may 2007 for small health plans), all covered entities using electronic communications (e.g., physicians, hospitals, health insurance companies, and so forth) must use a single new npi. the npi replaces all other identifiers used by health plans, medicare, medicaid, and other government programs. however, the npi does not replace a provider's dea number, state license number, or tax identification number. the npi is 10 digits (may be alphanumeric), with the last digit being a checksum. the npi cannot contain any embedded intelligence; in other words, the npi is simply a number that does not itself have any additional meaning. the npi is unique and national, never re-used, and except for institutions, a provider usually can have only one. an institution may obtain multiple npis for different "sub-parts" such as a free-standing cancer center or rehab facility. enforcement rule on february 16, 2006, hhs issued the final rule regarding hipaa enforcement. it became effective on march 16, 2006. the enforcement rule sets civil money penalties for violating hipaa rules and establishes procedures for investigations and hearings for hipaa violations. for many years there were few prosecutions for violations. this may have changed with the fining of $50,000 to the hospice of north idaho (honi) as the first entity to be fined for a potential hipaa security rule breach affecting fewer than 500 people. rachel seeger, a spokeswoman for hhs, stated, "honi did not conduct an accurate and thorough risk analysis to the confidentiality of ephi as part of its security management process from 2005 through jan. 17, 2012." this investigation was initiated with the theft from an employees vehicle of an unencrypted laptop containing 441 patient records. wikisource has original text related to this article: american recovery and reinvestment act of 2009/division a/title xiii/subtitle d as of march 2013, the u.s. dept. of health and human services (hhs) has investigated over 19,306 cases that have been resolved by requiring changes in privacy practice or by corrective action. if noncompliance is determined by hhs, entities must apply corrective measures. complaints have been investigated against many different types of businesses such as national pharmacy chains, major health care centers, insurance groups, hospital chains and other small providers. there were 9,146 cases where the hhs investigation found that hipaa was followed correctly. there were 44,118 cases that hhs did not find eligible cause for enforcement; for example, a violation that started before hipaa started; cases withdrawn by the pursuer; or an activity that does not actually violate the rules. according to the hhs website, the following lists the issues that have been reported according to frequency: misuse and disclosures of phi no protection in place of health information patient unable to access their health information using or disclosing more than the minimum necessary protected health information no safeguards of electronic protected health information. the most common entities required to take corrective action to be in voluntary compliance according to hhs are listed by frequency: private practices hospitals outpatient facilities group plans such as insurance groups pharmacies title iii: tax-related health provisions governing medical savings accounts title iii standardizes the amount that may be saved per person in a pre-tax medical savings account. beginning in 1997, a medical savings account ("msa") became available to employees covered under an employer-sponsored high deductible plan of a small employer and self-employed individuals. title iv: application and enforcement of group health insurance requirements title iv specifies conditions for group health plans regarding coverage of persons with pre-existing conditions, and modifies continuation of coverage requirements. it also clarifies continuation coverage requirements and includes cobra clarification. title v: revenue offset governing tax deductions for employers title v includes provisions related to company-owned life insurance for employers providing company-owned life insurance premiums, prohibiting the tax-deduction of interest on life insurance loans, company endowments, or contracts related to the company. it also repeals the financial institution rule to interest allocation rules. finally, it amends provisions of law relating to people who give up united states citizenship or permanent residence, expanding the expatriation tax to be assessed against those deemed to be giving up their u.s. status for tax reasons, and making ex-citizens' names part of the public record through the creation of the quarterly publication of individuals who have chosen to expatriate. effects on research and clinical care the enactment of the privacy and security rules has caused major changes in the way physicians and medical centers operate. the complex legalities and potentially stiff penalties associated with hipaa, as well as the increase in paperwork and the cost of its implementation, were causes for concern among physicians and medical centers. an august 2006 article in the journal annals of internal medicine detailed some such concerns over the implementation and effects of hipaa. effects on research hipaa restrictions on researchers have affected their ability to perform retrospective, chart-based research as well as their ability to prospectively evaluate patients by contacting them for follow-up. a study from the university of michigan demonstrated that implementation of the hipaa privacy rule resulted in a drop from 96% to 34% in the proportion of follow-up surveys completed by study patients being followed after a heart attack. another study, detailing the effects of hipaa on recruitment for a study on cancer prevention, demonstrated that hipaa-mandated changes led to a 73% decrease in patient accrual, a tripling of time spent recruiting patients, and a tripling of mean recruitment costs. in addition, informed consent forms for research studies now are required to include extensive detail on how the participant's protected health information will be kept private. while such information is important, the addition of a lengthy, legalistic section on privacy may make these already complex documents even less user-friendly for patients who are asked to read and sign them. these data suggest that the hipaa privacy rule, as currently implemented, may be having negative impacts on the cost and quality of medical research. dr. kim eagle, professor of internal medicine at the university of michigan, was quoted in the annals article as saying, "privacy is important, but research is also important for improving care. we hope that we will figure this out and do it right." effects on clinical care the complexity of hipaa, combined with potentially stiff penalties for violators, can lead physicians and medical centers to withhold information from those who may have a right to it. a review of the implementation of the hipaa privacy rule by the u.s. government accountability office found that health care providers were "uncertain about their legal privacy responsibilities and often responded with an overly guarded approach to disclosing information ... than necessary to ensure compliance with the privacy rule". reports of this uncertainty continue. costs of implementation in the period immediately prior to the enactment of the hipaa privacy and security acts, medical centers and medical practices were charged with getting "into compliance". with an early emphasis on the potentially severe penalties associated with violation, many practices and centers turned to private, for-profit "hipaa consultants" who were intimately familiar with the details of the legislation and offered their services to ensure that physicians and medical centers were fully "in compliance". in addition to the costs of developing and revamping systems and practices, the increase in paperwork and staff time necessary to meet the legal requirements of hipaa may impact the finances of medical centers and practices at a time when insurance companies' and medicare reimbursement is also declining. education and training education and training of healthcare providers is a requirement for correct implementation of both the hipaa privacy rule and security rule. hipaa acronym although the acronym hipaa matches the title of the 1996 public law 104-191, health insurance portability and accountability act, hipaa is sometimes incorrectly referred to as "health information privacy and portability act (hippa)." violations a breakdown of the hipaa violations that resulted in the illegal exposure of personal information. according to the us department of health and human services office for civil rights, between april 2003 and january 2013, it received 91,000 complaints of hipaa violations, in which 22,000 led to enforcement actions of varying kinds (from settlements to fines) and 521 led to referrals to the us department of justice as criminal actions. examples of significant breaches of protected information and other hipaa violations include: the largest loss of data that affected 4.9 million people by tricare management of virginia in 2011 the largest fines of $5.5 million levied against memorial healthcare systems in 2017 for accessing confidential information of 115,143 patients and of $4.3 million levied against cignet health of maryland in 2010 for ignoring patients' requests to obtain copies of their own records and repeated ignoring of federal officials' inquiries the first criminal indictment was lodged in 2011 against a virginia physician who shared information with a patient's employer "under the false pretenses that the patient was a serious and imminent threat to the safety of the