Skip to main content

Home/ Healthcare 2.0/ Group items tagged kinds

Rss Feed Group items tagged

Roger Steven

Healthcare Rehabilitation is a vast field - 0 views

  •  
    Healthcare Rehabilitation is a vast field: The field of healthcare rehabilitation is very vast and expansive. In traditional societies, most commonly relatable to the Orient and Africa, there is the ages-old cultural belief that it is the duty of children to take care of their parents when they age. On the contrary, for us in the west, healthcare rehabilitation has emerged as a specialized branch of healthcare because of the emphasis our society places on independence of the individual. Healthcare rehabilitation is a product of social mores: Younger generations of people are not expected to spend entire years, as may be the case in some families, to look after people of their previous generations who may be in need of medical care. It is on this outlook towards life of our society that healthcare rehabilitation has come into being. However, it is also possible that younger people could also be in need of healthcare rehabilitation. Even such people are put in the care of healthcare providers which offer these services. The divisions of healthcare rehabilitation: Branching out as a fully developed field of healthcare, healthcare rehabilitation has many specializations. These are broadly the areas in which healthcare rehabilitation is offered: General rehabilitation: General rehabilitation of some or another kind is a primary aspect of healthcare rehabilitation. Those in need of this kind of care typically include patients who have lost their ability to carry out day-to-day tasks such as talking, walking, brushing, eating, etc. many a time, depending on the nature of the ailment, rehabilitation could include therapies, exercises and other activities aimed at bringing in some element of mobility in the patient. This kind of healthcare rehabilitation could also include taking care to revive the patient's memory, when patients with diseases like Alzheimer's or Parkinson's are admitted for healthcare rehabilitation. Skilled nursing: An area in which a skilled and
Roger Steven

A look at disruptive practitioner behavior policies - 0 views

  •  
    A look at disruptive practitioner behavior policies: One of the very important factors needed for a healthcare unit to maintain its decorum and uphold its reputation is the implementation of disruptive practitioner behavior policies. The declaration and implementation of disruptive practitioner behavior policies goes a long way in ensuring that the hospital or healthcare center doesn't lose face. What are disruptive practitioner behavior policies? First, an understanding of disruptive practitioner behavior policies: Disruptive practitioner behavior policies may be termed as the putting in place in a healthcare providing unit a set of policies that are aimed at checking the errant and rude behavior of its staff members towards the patients and other people that use the services rendered by these centers. Who all carry out disruptive practitioner behaviors? Anyone in the healthcare setting can behave in an unbecoming and ungainly fashion with patients or those attending on them. Some of the typical types associated with disruptive practitioner behavior include shouting at them, bullying, intimidating, scolding loudly, being aggressive towards them, gesturing lewdly to them, and so on. This kind of behavior reflects very badly on the healthcare provider. Since there is intense competition in the healthcare providing industry; it is natural for patients to look for other centers when they face this kind of behavior. It is after all human to expect to be treated nicely. If one provider doesn't do that; patients look for other providers. Losing the patient, bad though it is, is not the only loss: When this becomes public, which is all the easier given the extensive reach of the social media; the healthcare unit's name goes for a toss. The role of disruptive practitioner behavior policies It is to curb this kind of behavior that disruptive practitioner behavior policies need to be put in place. Disruptive practitioner behavior policies can go a long way in reining i
Roger Steven

Conducting Emotionally Difficult Conversations - 0 views

  •  
    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

Implementation of Regulatory Aspects of Clinical Research is critical - 0 views

  •  
    Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm
Roger Steven

Workplace Safety Regulations - 0 views

  •  
    Workplace Safety Regulations : Workplace safety is a matter of grave importance to any organization. Ensuring the safety of workers is a primary goal of most countries, no matter which kind of political system or setup they have. This is because almost no workplace is free from some or another kind of hazard. These workplaces could be as varied as hospitals, construction sites, engineering plants or agriculture and many more. Governments the world over consider it their duty to provide a safe workplace. Workplace safety can concern any hazard that can happen to either the physical or emotional wellbeing of a worker. National and global workplace safety regulations : Workplace safety regulations are legally stipulated measures that governments require organizations in both the private and public sector to implement in order to ensure safety at the workplace. Almost all countries have their own set of workplace safety regulations. These regulations work in tandem with a few global management systems with the aim of enhancing safety standards at the workplace. A notable global organization that is at the forefront of legislating workplace safety regulations is the International Labor Organization (ILO). These ILO-mandated legislations are meant to supplement the national workplace safety regulations that most countries have. This is done in the belief that many a time, these individual legislations may not be sufficient in themselves. Workplace safety regulations in the US : Like most other countries, the US too has its own set of Occupational Safety and Health (OSH) standards. Owing their origins to the Richard Nixon era in late 1970; workplace safety regulations in the US concretized under what is collectively called the Occupational Safety and Health Administration (OSHA). The major feature of OSHA is that apart from promulgating workplace safety regulations across nearly all conceivable sectors and types of industries; OSHA also has a provision for whistleblow
Roger Steven

It is important to ensure food safety in hospitals - 0 views

  •  
    It is important to ensure food safety in hospitals Hospitals being what they are - where patients of almost all kinds visit or stay - are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination is the food that comes into hospitals. Food safety in hospitals is a very important element of hygiene First, an understanding of food safety in the context of hospitals is necessary. Food safety in hospitals is described as the scientific way by which food is prepared, handled and stored in hospital settings. Any food that is prepared in hospital kitchens are, like food prepared in other places such as canteens, hotels and restaurants and even homes, sourced from outside. This food comes from suppliers whose hygiene has to be ensured. Food hazards can come in many forms, including, but not limited to: Biological Chemical Physical Allergenic Hazards an Several other contributing factors It is in the process of procuring materials for food and preparing it in hospital kitchens that a major part of food safety in hospitals is compromised. There has to be a thorough mechanism to ensure that all these producers and suppliers follow regulatory requirements in ensuring that the food they produce and supply to hospitals is clean and safe. Literally thousands of patients get infected from over 250 kinds of bacteria, parasites and viruses when they consume food prepared in hospitals. Findings of a recent study It is pertinent to recall the findings of study done in May 2014 in Geneva, Switzerland. It carried out an examination of chicken supplied to and prepared in a hospital in this city. An astounding four fifths of these chickens were known to have been infected with E.coli, leading to its possible transmission to pati
Roger Steven

New HIPAA Rules - Meeting Requirements for New Patient Rights and New Restrictions on D... - 0 views

  •  
    Overview: New changes modifying the HIPAA Privacy and Security Regulations are going into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. The changes include establishing new rights for individuals as well as changes to the limitations on uses and disclosures. New requirements for patient access to records and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restriction and accounting of disclosures and increased enforcement activity. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And if you are required to have a HIPAA Notice of Privacy Practices, you will need to update that to show all the new rights that patients will have, such as electronic copies, new rights to restrict disclosures, and much more. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. If a business associate supplies services that interact with the new changes to the rules, the BA will need to be aware of the new requirements. We will explain what a Business Associate needs to do differently under the new regulations. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically. The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be chang
Roger Steven

Construction Safety Orientation - 0 views

  •  
    Construction Safety Orientation Construction Safety Orientation is part of Occupational Safety and Health Administration (OSHA)'s safety initiatives for those employed in the construction industry. Construction Safety Orientation is offered to employers and employees in the construction industry by OSHA or its authorized trainers. Construction Safety Orientation is offered as either a 10-hour or 30-hour course to employees by OSHA-authorized trainers. The aim of the Construction Safety Orientation training is provide training to employees and employers in this industry to help them recognize, abate, avoid, and prevent injuries in the workplace. In addition, Construction Safety Orientation also involves providing training to the employees and employers about their rights and duties at the workplace. s Outreach Training Program is voluntary There are two reasons for OSHA recommends Construction Safety Orientation: OSHA's Outreach Training Program is voluntary; OSHA's Outreach Training Program, being basic, does not provide the full training requirements that the employer has to meet under set OSHA standards. Because of this reason, OSHA's Outreach Training Program is not considered a certification. The need for Construction Safety Orientation The sheer size of the American construction industry is the best reason for the need for Construction Safety Orientation: A little over two percent of the entire American population - something like 6.5 million people are engaged in the construction industry at more than a quarter of a million construction sites across the nation. This perhaps gives some perspective of the magnitude of the tendency for injuries and deaths in this industry. In fact, it is known that construction accounts for the highest rate of fatal injuries among all industries in the US. In a construction workplace, workers could be prone to almost any kind of injury or hazard. According to osha.gov, the most common reasons include: Falls (from heights);
Roger Steven

Basics of the Anti-Kickback Statute - 0 views

  •  
    Basics of the Anti-Kickback Statute : The Anti-Kickback Statute is aimed at curbing abuse and fraud in the Medicare and Medicaid systems by professionals who offer services and benefit in direct or indirect ways. In order to protect Medicare and Medicaid patients, as well as federal health care programs from abuse and fraud; the Anti-Kickback Statute was enacted. The core act that the Anti-Kickback Statute considered as fraud and abuse is the unlawful acceptance or diversion of money into influencing medical decision-making. The Anti-Kickback Statute is very clear on this. It states that anyone in the healthcare industry, who consciously and deliberately accepts a fee or remuneration of any kind or offers the same with the intention of manipulating the course of a medical decision-making, is liable to punishment. What acts attract penalties? Acts of various kinds attract penalties under the Anti-Kickback Statute. Some of these include: Carrying out advertising or marketing activities for promoting the brand of health care providers Participating in affiliate programs or pay per click commissions Working out promotion agreements with multiple companies Taking part in sponsorships Working out strategic alliances with healthcare providers Licensing content or technology Selling a healthcare provider's brands of products or services Taking a cut in the advertising revenue The nature of penalties under the Anti-Kickback Statute The Anti-Kickback Statute states major penalties for acts it prohibits. The Anti-Kickback Statute prescribes these major penalties: Up to five years in prison This has the potential to attract additional monetary fines of up to $25,000 Administrative civil money penalties that can go up to $50,000 In addition, the Office of Inspector General (OIG) could initiate administrative proceedings and take steps aimed at prohibiting anyone convicted of an Anti-Kickback violation from participating in State and federal programs. The OIG could also impose
Roger Steven

HIPAA Audits for 2016 - How to Prepare for the New Round of HIPAA Audits - 0 views

  •  
    Overview: In this session we will discuss the HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits. We will explore what kind of issues and what kind of entities had the most problems, and show where entities need to improve their compliance the most. We will also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in the new 2016 audits. We will review the contents of the HIPAA Audit Protocol used in 2012 to show what documentation needs to be on hand should your organization be selected for an audit in the new round. We will present methods for using the contents of the HIPAA Audit Protocol to build your own compliance plan by extracting and updating the contents and relating your compliance activities directly to the questions that might be asked. In this session we will discuss the HIPAA audit and enforcement regulations and processes, and how they apply to HIPAA covered entities and business associates. We will explain the enforcement regulations and the new, increased fines and new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will discuss what information and documentation must be prepared in advance so that you can be ready for an audit at any time, including sample information request forms and questions asked at prior audits. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement activity. The HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary
sachin_cmi

An Insight into how Innovative Rigid Knee Braces are Helping Patients with Osteoarthrit... - 0 views

  •  
    Rigid Knee Braces are the most popularly used orthoses for the treatment of osteoarthritis pain. In fact, they are one of the major breakthroughs in the field of orthopedic therapy and orthopedic manufacturing. Rigid Knee Braces are very simple and easy to use. Unlike the traditional braces, these braces do not have any wires or screws that have to be threaded onto the bones. They can be worn at any time. The wires used here are made up of rubber. This helps to prevent the wires from creating discomfort to the bones of the knee. Furthermore, the wire used in these braces also prevents the fluid formation that is common in traditional braces. These braces help in exercising the stabilizers, tendons, and muscles that surround the joint. They also help in maintaining proper alignment of the bones. The tendons and muscles get stronger when they are properly exercised. Moreover, it also increases bone density. This makes the knee more resilient to shock and pain. Another important thing about Rigid Knee Braces is that it helps in reducing the pain felt in the knee. It is due to this reason that more people suffering from osteoarthritis are opting for these braces. The kind of osteoarthritis knee brace which can be used by a person depends on the severity of his or her problem. In general, there are two kinds of braces that are available. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/an-insight-into-how-innovative-rigid.html
seth morris

A Different Kind of Euphoria with a Legal Pot - 2 views

Looking for a legal pot that is totally intense without getting a hangover the next day is hard to find. But with Herbal Highs Online, we have found the right one. As we were browsing through the p...

Kronic

started by seth morris on 08 Jun 11 no follow-up yet
Roger Steven

OSHA's Standards on Fire Protection in the Workplace - 0 views

  •  
    OSHA's Standards on Fire Protection in the Workplace : When it comes to Fire Protection in the Workplace; there are several guidelines to be followed. One could go by common sense, but it is not usually sufficient, which is why OSHA has standards relating to Fire Protection in the Workplace. Like it does for all its safety requirements; OSHA requires the employer to take obligatory steps for the protection of employees from fire. These are covered in Title 29 of the Code of Federal Regulations Part 1910 Subparts E and L; and Part 1926 Subparts C and F. Employer obligations are the core of Fire Protection in the Workplace Requiring employers to carry out roles during a fire emergency and training employees towards the same are the foundation of OSHA standards on Fire Protection in the Workplace. Training employees on OSHA's standards on Fire Protection in the Workplace entails training them on all the core areas of handling a fire: The ways of using fire exits The ways of using fire extinguishing equipment The ways by which to organize an emergency exit plan The ways of using fire exits: Fire Protection in the Workplace on fire exits involves having to put in place a well-designed exit route for employees, so that they escape during a fire easily. These should be done keeping in mind the structure of the building. Keeping the exit route free of obstacles is another important requirement of OSHA's standards on Fire Protection in the Workplace. The ways of using fire extinguishing equipment: Having portable fire extinguishing equipment is not mandatory for OSHA, but employees must be properly trained on their use, should an employer have one. These equipment have to be placed at a convenient location for everyone to access easily. The ways by which to organize an emergency exit plan: An emergency exit plan is required as part of Fire Protection in the Workplace for some kinds of employers. It is for those whose activity involves the heavy use of hazardous chemica
Roger Steven

Health Insurance Market Reforms under Obamacare - 0 views

  •  
    Health Insurance Market Reforms under Obamacare: The Patient Protection and Affordable Act (PPACA), or Obamacare, sets out a number of provisions for health insurance market reforms. Having been set in motion in March 2010; the PPACA sets out health insurance market reforms that are being implemented in stages from dates commencing generally from January 1, 2014. PPACA's health insurance market reforms are aimed at health insurance standards and group health plans. These reforms set out dates for the implementation of these reforms. They also prescribe penalties for noncompliance with these reforms. What kinds of market reforms are needed? The health insurance market reforms suggested by PPACA are almost singularly for group health plans. A group health plan is defined as one in which the employer makes a contribution into expenses accruing from the employee's health insurance plans. When an employer chooses to bring an employee's health plan under her coverage; the employer has to mandatorily comply with the provisions of the health insurance market reforms. Areas of the health insurance market reforms: These are the essential areas in which the health insurance market reforms are to be applied: Removal of lifetime and annual limits on essential health benefits: One of the primary provisions of the health insurance market reforms under PPACA is that it prohibits both lifetime and annual limits on essential health benefits, which were allowed some dollar limits prior to enactment of Obamacare. Preventive health services: An area of preventive health services that has undergone an amendment under the health insurance market reforms is that of no-cost sharing. Accordingly, employer plans are to offer preventive health services without requiring the employee to share the burden for this part of the plan. The three-month waiting period: The health insurance market reforms don't require a waiting period of over 90 days. A waiting period is the period that has
Roger Steven

Social media and healthcare make a great pair - 0 views

  •  
    Social media and healthcare: The advent of the social media into the healthcare industry has thrown open a hitherto unknown dynamic. It presents the industry the kind of opportunities that were hard to come by till now. Yet, it is full of challenges. It is now an inescapable fact and a given: the onslaught of the social media into the healthcare industry cannot be reversed. The wave is too strong to resist. The explosion in the use of social media has impacted the healthcare industry on a scale that is unprecedented. The universal pervasiveness of the social media Social media and healthcare have become great buddies mainly because of the sheer power of reach of the social media. What started out essentially as services that shared photos and messages has turned out to be a giant opportunity for the healthcare industry. Today, it is something that no one in the healthcare industry -or those outside it, such as the lay young population that seeks medical information - is insulated from. Now, not only patients, but also physicians and everyone of any significance in the healthcare industry use the social media to disseminate information. Social media and healthcare have become strongly paired also because they help in keeping the patient in close contact with the healthcare provider. It is no surprise that the social media have broken the barriers of age and geography in reaching out to the highest and widest range of users. Some trends about social media and healthcare: It is estimated that a fifth of the entire American population exchanged medical information over the social media in 2010 About three-fourths of all patients use the social media for some information before reaching a healthcare provider At least a thousand top US hospitals use social media for communicating with patients and providers Globally, up to half a billion people could be linking social media and healthcare by using the former Now, the challenges: Despite social media in t
Roger Steven

OIG CIAs: What Do They Mean To Your Compliance Program? - 0 views

  •  
    Overview: Learn how to improve your healthcare compliance program by using requirements found in corporate integrity agreements (CIAs) issued by the OIG. By proactively incorporating various features of CIAs, healthcare providers of all types can be better assured of meeting compliance standards. While there are many different types of healthcare compliance issues, probably the area of most concern is that of properly filing claims and receiving appropriate reimbursement. The OIG has issued various types of guidance including Federal Register entries, fraud alerts, and issues as listed in the OIG Work Plans. By providing such guidance, the OIG has given healthcare providers notice so that there can be no defense of not knowing about an issue. By organizing your compliance program to detect and then correcting various types of issues is a major objective of having a compliance program. Understanding systematic processes for improving your healthcare compliance program using CIA requirements can forestall possible criminal and civil monetary penalties. The hundreds of CIAs that have been developed when the OIG detects fraudulent activities can be used as a guide for developing and improving healthcare compliance programs for all types of healthcare providers. The process of statistical extrapolation is used by the OIG when conducting studies in order to determine recoupment amounts. Statistical extrapolation can also be used by healthcare providers when determining possible overpayments. However, the proper use of statistical extrapolation is a formal and complex mathematical process that must be properly applied. The OIG CIAs provide another resource for healthcare providers to study, understand, and then apply as appropriate. Why should you Attend: What are the OIG Corporate Integrity Agreements (CIAs)? Why does the OIG issue CIAs? Can I use general requirements from CIA to avoid monetary penalties or even avoid going to jail? Can any healthcare provider use
Roger Steven

HIPAA Breach Notification Rules and its new version - 0 views

  •  
    HIPAA Breach Notification Rules and its new version : Let us begin at the beginning: What is breach notification? The term is pretty simple to understand. It means notifying the authorities whenever there is a breach of Protected Health Information (PHI). Covered Entities (CE's) and Business Associates (BA's), who are closely associated with PHI, and individuals whose PHI data are breached, are required to bring such data breaches to the notice of the authorities, whenever there is one. A breach notification is a mechanism that is aimed at ensuring that BA's and CE's meet requirements in the HITECH Act in the American Recovery and Reinvestment Act of 2009 (ARRA). To whom should the affected individuals and CE's and BA's complain? Whenever there is a breach of PHI by a CE or a BA, or if there is violation of the Privacy, Security, or Breach Notification Rules, the affected individual can complain to the Office for Civil Rights (OCR), which will initiate investigation into these complaints. Whenever a CE or a BA detects a breach, it can complain to the Secretary of Health and Human Services (HHS). In addition, the HIPAA breach notification rules have clear guidelines on how to report breaches in the following classifications: HIPAA's definition of a breach A breach of PHI is said to have taken place when any unpermitted use or disclosure that compromises the security of the data in the PHI takes place. Any such action, resulting in the breach of any kind of data contained in a PHI, big or small, is considered a breach, unless the CE or BA can explain that the data that got breached into was not serious enough, from its risk assessment point of view, to warrant immediate intervention. The new HIPAA breach notification rules The HHS embarked on a new HIPAA breach notification program, the HIPAA Privacy, Security, and Breach Notification Audit Program, with which it seeks to bring a few changes into the existing HIPAA breach notification rules. This new Audit Pr
Roger Steven

Rationale for Clinical Trial Regulations - 0 views

  •  
    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

HIPAA Breaches and help from Cybersecurity Insurance - 0 views

  •  
    Overview: Remember spaghetti code? The HIPAA breach area is now almost as convoluted and overlapping and confusing as spaghetti code. Sometimes you think you are both coming and going at the same time when you think through an event to determine if your organization has had a breach. For example: Is a security incident always a beach? Is an ePHI breach a security incident as well? Is a cybersecurity event always a breach? What if it does not steal any clinical information, diagnoses or procedures information, or any payment information? A security incident? Or both? Are all the necessary kinds of notice in the Breach rule? What is Cybersecurity Insurance? Is it really the finger in the dike or itself full of Swiss cheese? Can the loss of patient or member data be a HIPAA breach and identity theft plus a fraud issue? Why should you Attend: HIPAA breaches now number in the multiple thousands, if not multiple millions. Your organization needs to be prepared for the initial sense of panic, a complete investigation, and the federal, state and reputational costs of a mega breach. A breach now costs in money approximately $225/record. And this does not include any fine of any type. The loss and theft of 1000 records may cost you organization from a quarter to $1 M, or more, and 6 months to a year to resolve. You need to know the basics of what PHI and ePHI really are; what puts the event into the breach safe harbor, what breach exceptions keeps the event out of OCR's hands, what the 4 factors are and how they are used. You need to know that your organization's breach plan and your policies and procedures include the need to notify when necessary the police, the FBI and other state and federal organizations beyond the Office for Civil Rights. Your organization needs to know how to protect itself after the fact by considering Cybersecurity Insurance. Areas Covered in the Session: Definition and reporting of a Security Incident Definition of a breach Breach Guidance Br
Roger Steven

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

  •  
    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
1 - 20 of 46 Next › Last »
Showing 20 items per page