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Roger Steven

Ethics and Laws for Mental Health Professionals- 2 day In person Seminar - 0 views

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    Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. A potential client has a wide choice of mental health providers from whom to choose. Yet each individual mental health profession has a unique education, training, and experience requirement for practice. While similarities exist, requirements differ from state to state and even from profession to profession with a single state. What are these requirements and how do they apply? The state's authority and power over mental health practitioners often presents challenges to these mental health professionals that are not easy to navigate. Differing sources of legal and ethical authority govern each respective health care practitioner in ways that are similar but not the same. Ethics and law are similar, but not the same. All mental health practitioners must adhere to standards of state law which govern their professional practices, including the very core of the doctor-patient relationship. Codes of ethics and state law may both apply to govern the conduct of this clinician. Even some state laws are referred to as ethical codes. Complaints as to alleged misconduct or ethical failings are received and investigated by a state agency and leave the mental health practitioner with an uncertain process to handle and to defend the state action against them. With this background, this seminar empowers the full understanding and application of ethics and laws for mental health practitioners. Learn to identify and understand an ethical framework for a sound mental health practice. An ethical framework is essential to having the right perspective to examine mental health dilemmas. Compare and contrast regulatory laws and codes of ethics to understand their differing applicability. Know the difference between laws and ethics,
Roger Steven

Medical Necessity: A Term in Search of Definition - 0 views

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    Overview: The idea of providing health care treatments and insurance coverage according to "medical necessity" determinations seems eminently reasonable. Its obvious ethical thrust is to discourage unnecessary, wasteful or fraudulent practices. As practically implemented, however, "medical necessity" regulations and determinations have proven remarkably controversial and elusive. First of all, the language connected with medical necessity is inherently vague. Language to the effect that a treatment is medically necessary if it is "likely to achieve a significant practical improvement," is "realistic," or "reasonable" will predictably cause disputes between payors and providers of care. Second, the persistence of these disputes calls into question whether evidence based practices have evolved to a point where they are all that reliable and useful. Third, medical necessity determinations incur problems as to who should ultimately make them: payors, health providers or the courts. Obviously, whoever controls the definition of medical necessity controls the flow of health care dollars. While ethical theory can offer important insights about our moral obligations, it remains unable to reliably translate its theoretical principles and rules bearing on harms, benefits and justice into informing medical necessity determinations. Thus, resolving disputes over medical necessity have taken a procedural approach that looks to the interpretation of contractual language in insurance policies, often at the bench of an administrative law judge. This presentation will advance a reasonable set of strategies whereby a convincing case can be made for certain care interventions qualifying as "reasonable and necessary." Why should you Attend: Despite their central importance as a locus for determining reimbursement, "medical necessity" regulations and determinations have proven remarkably controversial and vexing for at least the last 20 years. Yet, whoever controls the definition
Roger Steven

What Practitioners need to know about the difference in Ethics and Law for Mental Healt... - 0 views

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    Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. Yet each individual mental health profession has a unique education, training, and experience requirement for practice. The state's authority and power over mental health practitioners often presents challenges to mental health professionals that are not easy to navigate. All mental health practitioners must adhere to standards of state law which govern their professional practices, including the doctor-patient relationship. Codes of ethics and state law may both apply to govern the conduct of this clinician. Complaints that are received and investigated by a state agency leave the mental health practitioner with an uncertain process to handle the state action against them. Learn to identify and understand an ethical framework for a sound mental health practice. Describe the inherent risks in mental health practice. Review the three most common violations of law against mental health clinicians. Compare and contrast regulatory laws and codes of ethics. Learn practical tips about how to avoid liability and manage risk in clinical settings. This allows the mental health care practitioner to avoid sanctions and to defend against legal actions which may result in ruinous practice and career consequences for the mental health practitioner. This program offers an objective, thorough review of ethics and law for mental health practitioners. Price : $139.00 Contact Info: MentorHealth Phone No: 1-800-385-1607 FaX: 302-288-6884 support@mentorhealth.com Event Link: http://bit.ly/Ethics-and-Law-for-MentalHealth-Professionals http://www.mentorhealth.com/ LinkedIn Follow us - https://www.linkedin.com/company/mentorhealth Twitter Follow us - https://twitter.com/MentorHealth1 Facebook Like us- https://
Roger Steven

Rationale for Clinical Trial Regulations - 0 views

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    Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl
Roger Steven

Understanding the Most Common Violations of Law against Psychologists - 0 views

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    Overview: Today's diverse, fast-changing, multidisciplinary mental health care environment involves many mental health care professionals who work together for the common goal of the patient. This includes physicians/psychiatrists, psychiatric nurses, psychologists, and others. Nothing in health care is more fractured than in mental health among a multitude of mental health practitioners. Like physicians/psychiatrists and psychiatric nurses, psychologists as health care practitioners obtained an education, passed applicable examinations, completed professional training, and hold a license to practice their chosen profession of psychology, often by being educated and trained at the doctoral level. The license to practice is issued by the state agency which has exclusive jurisdiction over this health care practitioner. Thereafter, the state's authority and power over the psychologist often presents challenges to that professional that are not easy to navigate. Their governing state agency routinely handles, investigates, and dismisses- or prosecutes - alleged violations of law that can be career ending for the psychologist if pursued. But that process takes time with many steps necessary for due process of law. One of the ultimate actions the state may take is to issue a suspension or revocation of the psychologist's professional license. Yet many state actions fall short of such drastic outcomes, but still have serious, permanent consequences for the psychologist as a licensed health care professional. Learn to identify the legal authority for state agencies to regulate the practice of psychology. Seek to understand and defend against state actions which may result in ruinous practice and career consequences for the health care professional. This program offers an objective, thorough review of the ethical and legal violations committed by psychologists. This program also reviews defenses with practice tips to defend successfully those common violations. Otherwis
Roger Steven

Conducting Emotionally Difficult Conversations - 0 views

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    Overview:  Emotionally difficult or painful conversations are very common in health care. Consequently, it is quite remarkable that health care training programs do not spend more time teaching future health professionals the kinds of emotional and relational skills that are often required in these kinds of patient-provider interactions. This presentation will discuss the architecture of the painful conversation by examining : Its effect on the professional's sense of self and especially his or her need to preserve self-esteem The critical role of feelings and emotions, and The nature and value of empathy. The latter half of the presentation will consist of various strategic and practical recommendations so that emotionally challenging conversations might be conducted artfully, especially with "difficult" or "impossible" patients. Areas Covered in the Session: By the end of this presentation, learners will be able to: Relate the painful conversation to their construction of their professional "self"; Explain how an ability to control one's feelings can influence the success or failure of an emotionally difficult conversation; List a number of empathic responses that are useful in conducting difficult conversations Who Will Benefit: Any health professional who has to communicate with others. Speaker Profile John D. Banja is a Professor in the Department of Rehabilitation Medicine and a medical ethicist at the Center for Ethics at Emory University. He also directs the Section on Ethics for the Atlanta Clinical and Translational Science Institute at Emory. Dr. Banja received a doctorate degree in philosophy from Fordham University in New York and has taught and lectured on topics in medical ethics throughout the United States. He has authored or coauthored over 200 publications and has delivered over 800 invited presentations at regional, national, and international conferences. He currently serves as the Editor of the American Journal
Roger Steven

An Ethical Use of Electronics, EHR, and e-Anything - 0 views

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    Overview: Essentially, covering in 90 minutes the basics of E everything that applies to your clinical work. We will give you the questions to ask your IT people, because you should not implicitly trust them, because the law will hold you accountable more than them. We will first cover the general principles of electronic compliances as laid forth in HIPAA. We will then discuss how this applies to your desktop/laptop/iPads and smart devices, other electronic equipment such as routers and modems. We also cover the use of email, secure mail and your EHR/EMR. We will discuss the pros and cons of using the cloud for your data storage and EHR/EMR, i.e. knowing what a HIPAA compliant data center looks like. Principles in the use of encryption and passwords and other security principles will also be covered. Why should you Attend: Unless you are 100% sure you've thought through every angle of your patient's electronic PHI and you sleep like a baby never concerned about this then you need to attend. If you have any questions about the details of what electronic compliance looks like and how it's applied in day-to-day clinical and business activities, interactions with vendors, EHR/EMR, your relationship with your ISP and IT providers, use of all electronic devices, then this workshop is for you. It also gives you principles to apply in new situations which are likely to arise frequently. If you wrote the book on this it would be out of date in 24 hours, so what's important is to learn how to think about these things and use your resources to stay ahead of the game. If you are confident you have the basics covered on every item listed below then this seminar is not for you. Areas Covered in the Session: HIPAA electronic compliance Secure use of EHR/EMR Email and secure mail use Encryption and password security principles Interfacing with the public Interfacing with vendors such as ISPs and other telecommunication companies Backups Cloud use How to know your data center
Roger Steven

The Basics of Professional Regulatory Law: Licensure and Certification, with an Emphasi... - 0 views

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    Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program
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    Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program
Roger Steven

Differences between Device and Drug Clinical Research- A Jeopardy Learning Game - 0 views

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    Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices. Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives: Define drug research Define device research Explore the differences between the two Describe requirements when drugs and devices are combined in one study Areas Covered in the Session: Defining Drug Research FDA approved drugs Investigational drugs Compassionate use Defining Device Research FDA approved devices 510 K devices Humanitarian Device Exemptions Invitro Diagnostic Devices Investigational Devices Federal regulations governing drugs and devices Guidance governing drugs and devices Combining devices and drugs into one study What are the requirements? What are the regulations and guidance? How these studies are reviewed Who Will Benefit: Investigators Researchers Research Staff Study Coordinators Auditors Research Administrators Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with st
Roger Steven

Trial Master File (TMF): FDA Expectations from Sponsors and Sites - 0 views

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    Overview: The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws. Why should you Attend: Anyone responsible for handling trial documentation or quality assurance activities. Areas Covered in the Session: Trial Master File (TMF): what is it? Essential documents required ICH guidelines and Good Clinical Practice (GCP) Food and Drug Administration (FDA) guidance and expectations Paper or electronic trial master files - what is allowable Links to useful resources Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research New Clinical Research Coordinator positions (1-2 years) New Principal Investigator positions Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research manageme
Roger Steven

FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Re... - 0 views

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    Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives
Roger Steven

The Sunshine Act: Reporting for Clinical Trials - 0 views

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    Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research Clinical Research Coordinators Principal Investigators/Physicians Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu
Roger Steven

What is Corporate Governance? | Robert Mariott | LinkedIn - 0 views

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    What is Corporate Governance? In a broad sense, corporate governance can be defined as a set of processes by which corporations are run and administered. These are a collective function of the critical, core decision makers in the organization, such as Directors, CEO, managers, investors, stakeholders, shareholders, creditors, auditors and others. Corporate Governance sets out the methods and rules for making rules that govern corporate entities. Although business is the main concern and task of an organization, Corporate Governance occupies as important a position, because while the financial aspect of a business is all about profits, the Corporate Governance aspect is primarily about its integrity, values and reputation. Corporate Governance takes into consideration all aspects of the governance of the organization from critical standpoints such as ethics, regulatory aspects, policies and mission, etc. History of the growth of Corporate Governance Although Corporate Governance has been around for a number of decades in some or another form, it came to acquire proper shape and direction of late, following the collapse of very big multinationals such as Enron, WorldCom and others. It was felt that their shady dealings, which led to huge losses for their stakeholders and eventually to the businesses collapse, could have been averted if a proper regulatory framework of Corporate Governance were in place. This is the feeling that led to the passing of the Sarbanes Oxley Act, or SOX in the early 2000's. One of the core principles enunciated in SOX related to Corporate Governance. Elements of Corporate Governance As a result of the SOX Act and other legislations in other developed countries, such as the Cadbury Report of the UK and other legislations in the OECD nations; Corporate Governance is now administered through a well-defined set of principles. As a result of these legislations, Corporate Governance is now concerned with the following: Problems areas of Co
Roger Steven

How to Ensure a Successful Health Care Systems Implementation - 0 views

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    Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program offers an obje
Roger Steven

Disposition of Records and Records Retention for Medical Records, Including Electronic ... - 0 views

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    Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addition to
Roger Steven

HIPAA Compliance and Patient Care - 0 views

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    Incidental disclosures form the crux of HIPAA compliance and patient care. HIPAA has elaborate rules on how to maintain these and in what situations. Health Insurance Portability and Accountability Act (HIPAA), a landmark set of federal regulations, is aimed at protecting patient privacy regulations. Yet, it is understood that some information has to necessarily be shared. HIPAA compliance and patient care is centered on the inevitable disclosures that have to be made, or what are called incidental disclosures. Initially, there was some ambiguity about incidental disclosures, resulting in some kind of haziness about HIPAA compliance and patient care. With these cleared, much of HIPAA compliance and patient care hinges on this principle. Incidental disclosures determine patient care compliance with HIPAA Incidental disclosures are what are termed secondary use, i.e., it is the unavoidable or inevitable disclosure of Protected Health Information. It is understood that incidental disclosures, being a byproduct of the course or nature of the treatment; are inescapable, given the condition and situation of the patient. Guiding factors for HIPAA compliance with patient care The aim of HIPAA's Privacy Rule is to ensure that healthcare providers have to use professional judgment guided by ethical guidelines at the time of making incidental disclosures. The following bases were propounded for adherence with HIPAA compliance and patient care: Whenever there is an unavoidable breach in confidentiality, the breach should be proportionate to the potential benefit the patient's gets from care When a patient is not present in the healthcare setting or is incapacitated, information about the patient can be shared with the family, friends or whoever else is involved in the patient's care. This protocol need not be documented. In relation to the above, a requirement of HIPAA compliance for patient care is that when the patient has a condition that is not related to the present tr
Roger Steven

Seminar on Internal Auditing for the Medical Device Industry at SFO, CA - 0 views

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    Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint
Roger Steven

The Drunk, High, or otherwise Impaired Health Care Practitioner: What can be done to Help - 0 views

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    Overview: Health care practitioners and other licensed professionals work in today's diverse, fast-changing, multidisciplinary environment. All licensed professions have higher rates of drug abuse, alcohol abuse, and mental health issues. Yet each individual profession has a unique, though similar, state laws which govern how state licensing agencies take action against the professional so as to protect the public. The state's authority and power over licensed professionals often presents challenges to the impaired practitioner that are not easy to navigate. All licensed professionals must adhere to standards of state law which govern their professional practices and include prohibitions for impaired practice - even impairment along that is apart from any direct professional harm. Complaints that are received and investigated by a state agency leave the licensed professional with an uncertain process to handle the state action against them. Coupled with numerous related consequences, such as loss of employment, family issues and divorce, and criminal actions, the licensed professional must handle all these challenges successfully. Learn to identify and understand varying state laws that apply to allow disciplinary action against the licensed professional, both immediately and temporarily, and those which are permanent and final. Review the most common successful elements of the rehabilitation of the licensed professional faced with the deadly consequences of addiction. Compare and contrast regulatory laws and due process requirements for state action. This allows the licensed professional to avoid career-ending sanctions and to defend successfully against legal actions which may result in ruinous practice and career consequences for the professional. This program offers an objective, thorough review of laws which apply to the impaired licensed professional. Why should you attend: Health care practitioners are faced with a higher lifetime risk of drug abuse,
Roger Steven

HIPAA Compliance Fundraising: What You Need to Know, What You Need to Do - 0 views

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    Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising. The webinar will cover how to effectively implement the fund raising regulations in a manner that increases both opportunities for philanthropic support and compliant implementation of the new mandates. The rules include specific operational requirements, some of which prohibit protocols that were required under the original HIPAA regulations. The "magic words" mandated by HIPPA-related regulations changed in multiple areas. The webinar will cover all of these areas to ensure your organization is both legally compliant and operationally effective. The types of information that may be used for fund raising changed significantly. This presents numerous substantial fund raising opportunities, as well as challenges on the use and storage of such information. Among other areas to be presented are The required method for individuals to opt-out of receiving fund raising communication The methods of informing patients and clients of their right to opt-out from receiving fund raising communication The broadly expanded types of fund raising communication subject to opt-out rights How providers, hospital, and related fund raising foundation apply an opt-out election by an individual The type of patient and client information that health charities may use for fund raising The contents of provider's Notice of Privacy Practice How clinicians can assist both their patients/clients and the
Roger Steven

Disposition of Records and Records Retention for Medical Records, Including Electronic ... - 0 views

  •  
    Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addit
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