Legal Considerations for Electronic Health Records.

Electronic health record (EHR) solutions provide many potential benefits for dental practices, whether those programs run internally on a dental practice's computers or are cloud-based solutions. However, these programs also create new risks for a dental practice, which may be mitigated through due diligence and adequate contractual provisions to ensure protection for dentists. This article addresses the legal considerations associated with a dentist entering into a service contract with an EHR vendor.

Maintaining proper dental records.

Referred to as Standard of Care, the legal duty of a dentist requires exercising the degree of skill and care that would be exhibited by other prudent dentists faced with the same patient-care situation. Primarily, the goal of keeping good dental records is to maintain continuity of care. Diligent and complete documentation and charting procedures are essential to fulfilling the Standard of Care. Secondly, because dental records are considered legal documents they help protect the interest of the dentist and/or the patient by establishing the details of the services rendered. Patients today are better educated and more assertive than ever before and dentists must be equipped to protect themselves against malpractice claims. Every record component must be handled as if it could be summoned to a court room and scrutinized by an attorney, judge or jury. Complete, accurate, objective and honest entries in a patient record are the only way to defend against any clinical and/or legal problems that might arise. Most medical and dental malpractice claims arise from an unfavorable interaction with the dentist and not from a poor treatment outcome. By implementing the suggestions mentioned in this course, dental health care professionals can minimize the legal risks associated with the delivery of dental care to promote greater understanding for patients of their rights and privileges to their complete record.

Implementing near real-time vaccine safety surveillance using the Clinical Practice Research Datalink (CPRD).

INTRODUCTION: Near real-time vaccine safety surveillance (NRTVSS) using electronic health records is increasingly used to rapidly detect vaccine safety signals. NRTVSS has not been fully implemented in the UK. We assessed the feasibility of implementing this surveillance using the UK Clinical Practice Research Datalink (CPRD). METHODS: We selected seasonal influenza vaccine/Guillain-Barré Syndrome (GBS) as an example of a rare outcome and measles-mumps-rubella (MMR) vaccine/febrile seizures as a positive control. For influenza/GBS we implemented a system for the 2013/2014 and 2014/2015 influenza seasons; for MMR/seizures the surveillance period was July 2014-June 2015. We used the continuous Poisson-based maximized sequential probability ratio test (PMaxSPRT), comparing observed-to-expected events, for both pairs. We calculated an age-sex-adjusted rate using 5years of historic data and used this rate to calculate the expected number of events in pre-specified post-vaccination risk-window (GBS: 0-42days, seizures: 6-21days). For MMR/seizures we also implemented the system using the Binominal-based maximized sequential probability ratio test (BMaxSPRT). For this, we compared seizures in the risk-window (6-21days) to a control window (0-5 and 22-32days). Delays in recording outcomes influence the data available, so we adjusted the expected number of events using a historical distribution of delays in recording GBS/febrile seizures. Analyses were run using data up to each CPRD monthly release. We also performed power calculations for detecting increases in relative risk (RR) from 1.5 to 10. RESULTS: For influenza/GBS we implemented a system in both seasons with no signal. Power to detect a signal was >80% for RR≥4. For MMR/seizures we were able to identify a signal with PMaxSPRT but not with BMaxSPRT. Power≥80% for RR≥2.5 for both tests. CONCLUSION: CPRD is a potential data source to implement NRTVSS to exclude large increases in the risk of rare outcomes after seasonal influenza and lower increases in risk for more frequent outcomes.

[Harmonization criteria for inspection procedures. Italian Group for Quality Assurance in Research]. / Criteri di armonizzazione delle modalità ispettive. GIQAR.

In order to achieve higher levels of harmonisation for the application of the principles of good laboratory practice (GLP), the monitoring Authority has set up for the inspectors some guidelines to conduct inspections, as approved by the National co-ordination committee. The extension of these guidelines should allow for an improved application of the GLP principles taking into account actual situations detected during inspections carried out over the past years. In this respect a great number of observations formulated by the inspectors after inspecting several test facilities have been examined without revealing laboratories' and inspectors' identities. In addition to this, the observations made by the inspectors during the annual training course at the Istituto Superiore di Sanità in 2000 have been carefully considered.

Guidance of FDA's expectations of medical device manufacturers concerning the year 2000 date problem--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem." The guidance, which is included in this notice, is a Level 1 guidance that is immediately effective in accordance with FDA's good guidance practices (GGP's) criteria, which allow immediate implementation of guidance that is necessary for public health reasons. FDA will receive comments on the guidance at any time and consider them in determining whether to amend the current guidance.

Privacy Act of 1974; computer matching program--HCFA. Clarification--computer match between HCFA and the Internal Revenue Service (IRS)--notice published in the Federal Register on July 5, 1989.

Pursuant to the Computer Matching and Privacy Protection Act of 1988, Public Law 100-503, October 18, 1988, and the Office of Management and Budget (OMB) Guidelines on the Conduct of Matching Programs, the IRS published a notice in the Federal Register (54 FR 28149; July 5, 1989) announcing their intention to conduct a match with a number of Federal and State agencies including HCFA. These matches, in accordance with various provisions of section 6103 of the Internal Revenue Code (IRC) of 1986, provide these agencies with tax information from IRS records to assist them in administering the programs and activities as described. The match with HCFA is pursuant to IRC 6103(1)(7). The IRS is required, upon written request, to disclose current information from returns with respect to unearned income to any Federal, State, or local agency administering certain federally approved programs to provide, among other things, medical assistance. HCFA is publishing this notice to ensure that the public is aware that it is participating in this match to verify Medicaid eligibility. The HHS Data Integrity Board has approved an Agreement between HCFA and the IRS on February 8, 1990, as required by the Computer Matching and Privacy Protection Act of 1988.

HIPAA is larger and more complex than Y2K.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a larger and more complex problem than Y2K ever was. According to the author, the costs associated with a project of such unending scope and in support of intrusion into both information and operational systems of every health care transaction will be incalculable. Some estimate that the administrative simplification policies implemented through HIPAA will save billions of dollars annually, but it remains to be seen whether the savings will outweigh implementation and ongoing expenses associated with systemwide application of the regulations. This article addresses the rules established for electronic data interchange, data set standards for diagnostic and procedure codes, unique identifiers, coordination of benefits, privacy of individual health care information, electronic signatures, and security requirements.

Copyright in the digital classroom.

Copyright law was developed to protect the rights of authors. Many educators are aware of copyright law, but they may not be aware of how it applies to them or of the law's scope in regards to computer technology. As the computer is used increasingly to disseminate information, teaching professionals also must have knowledge of the applications of the law to this developing technology. This article reviews the laws defining copyright and fair use. It examines case law regarding copyright, computers, and the Internet. Recommendations for using computers to disseminate class materials to students are discussed.

See you in court. Damage inflicted by the Y2K bug threatens to become a dream for litigators but a nightmare for healthcare executives.

Most hospitals and health systems perceive and treat the year-2000 faulty computer code as a technical problem, but it is a high-level management problem. If hospitals don't start preparing comprehensively, they will face a host of consequences. Experts say spillover will extend into business issues, finances and liability. But providers must choose their most important priorities and develop contingency plans.

Beyond the hype. Proven strategies for fixing the year 2000 problem.

Many health care organizations are developing effective strategies for coping with the year 2000 problem, assuring that computers with two-digit date fields will recognize that 00 signifies 2000. Clinics, hospitals and other sites are finding that in addition to fixing their core information systems, they also must carefully analyze the year-recognition capabilities of crucial medical devices--and even elevators.

Information technology. The bug stops here.

The millennium bug arises because up to the 1980s computers were programmed to represent years by the last two digits only. So, when the millennium arrives, programmes which represent the year 2000 as 00 will be unable to make the transition from 1999 into the 21st century. Such programs have been written into microchips, hardware and software. The problem is not restricted to computers, but extends to systems that rely on embedded chips, such as air conditioning, lifts, lighting, security and electro-medical equipment. The potential catastrophic consequences for patient care and administration are clear, and raise liability issues of which NHS managers need to be aware.