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Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Course "HIPAA - Putting an Organizational Compliance Program in Place" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course. Why you should attend: With an increase in HIPAA enforcement and Phase 2 audits underway, many organizations need to fully understand the requirements of a compliance program. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk. The seminar will include practical exercise to assist in knowing how to develop, review, and amend HIPAA policy and procedure. After completing this course, a Covered Entity or Business Associate will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: · Why was HIPAA created? · What is HITECH and the Omnibus Rule? · Who Must Comply with HIPAA Requirements? · What are the HIPAA Security and Privacy Rules? · What i

Cycling has always been one of the most efficient ways to slim down, but requires space indoors and outdoor travel. But now, using the Vissco Cycle Exerciser, you can sit down comfortably on any stool or chair and pedal away those unwanted flabby areas of the calves, hips, thighs and abdomen. Pedaling action takes inches off your figure thereby toning and firming your muscles. WHEN TO USE To exercise lower limbs Weight loss Strengthening of lower limb muscles New Cycle Exerciser Features Strength and range of motion exercises help improve joint function Pedaling uses thigh muscles: quadriceps to push down, and hamstrings to pull up during the circular motion Cycling workout results in isometric engagement of the abdomen as a supporting muscle group Range of motion exercises help improve joint function Reduce hip pain caused by bone diseases such as osteoarthritis and necrosis Cycle can be used in preferably recumbent position or in sitting position

Overview: Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facility toward full compliance with HIPAA. The by-product of this presentation will be both an understanding of, and a detailed job description for, a position mandated in the regulations - the HIPAA Security/Privacy Officer. Why should you attend: The HIPAA regulations are numerous, complicated, often vague, and affect every person working in a healthcare facility. Compliance with HIPAA will require a unique individual to lead the charge - an individual whose education, background, experience, and demonstrated skill sets offer the opportunity for that person to succeed in achieving the goals of that position. This is a new position to most healthcare facilities. So understanding who this person should be, what is required of the person with this job title, and with whom this person will interface is vital to every healthcare organization with the goal of achieving full compliance with HIPAA. Areas Covered in the Session: Position goals Position requirements (education, experience, skill sets, etc.) Position responsibilities Stay abreast of regulations Initiate compliance with HIPAA (according to regulations) Ensure continuous progress toward full compliance Develop appropriate security/privacy policies & procedures Oversee and deliver appropriate training programs to all employees Track compliance with HIPAA regulations at the facility & individual levels Track access to PHI Investigate and resolve HIPAA violations Apply sanctions to HIPAA violators Manage any information security personnel Prepare a department budget Hold Bu

Protein A colorimetric resins are the most extensively used affinity purifiers in bio-manufacturing and other industries. Protein A colorimetry is a robust, high-throughput chromatography method and is used primarily as a capture step because of its inherent precision. Approval and launch of new biosimilars is expected to propel growth of the protein A resin market. For instance, in December 2020, Sandoz Canada Inc., a generics and biosimilars manufacturer and a division of the Switzerland-based multinational Novartis AG, received Health Canada authorization for Hyrimoz (adalimumab injection, reference biologic drug: Humira) on November 4, 2020 for marketing in Canada. Hyrimoz, the new biosimilar, has been approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and adult uveitis. Moreover, high prevalence of chronic diseases is also expected to aid in growth of the protein A resin market. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/emergence-of-covid-19-to-offer_23.html

Disposable syringes are designed for one-time use and is discarded in order to prevent the spreading of infection. It can be defined as a sterile cylindrical medical instrument with a hollow needle at the end. This device act as a pump that easily draws drugs from vials and delivers these drugs to the body. A syringe is used to deliver injectable drugs in the body through an intravenous route. The growing use of injectable drugs across the healthcare sector is predominantly fueling the market growth of disposable syringes. The rise in global healthcare expenditure is another key factor propelling the market growth of disposable syringes. According to the World Health Organization, global spending on health was US$ 7.8 trillion in 2017 or about 10% of GDP and $1,080 per capita - up from US$ 7.6 trillion in 2016. Moreover, the growing demand for self-injection devices & long-acting formulations is again propelling the market growth. Increasing spending on R&D of new drugs development coupled with the growing demand for biologics will further favor the market growth of disposable syringes. Furthermore, growing concerns regarding needle stick injuries and accidental infections are also expected to bolster the market growth of disposable syringes. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/11/increasing-spending-on-r-of-new.html

Radiofrequency ablation is a relatively new method of reducing pain associated with back pain. In a recent review published by an organization that studies medical innovations, the Global Commission on Systemic Palliative Care (GCSPC) stated that the most common application for radiofrequency ablation is the treatment of pain in the spine, which has been used since the 1970s. There are many other applications, although these are two examples of the typical type of pain that this device is used to relieve. Rising prevalence of cancer is expected to drive growth of the global radiofrequency ablation device market during the forecast period. The number of cancer cases has increased over the years globally. According to the World Health Organization (WHO), in 2018, around 18.1 million new cases of cancer and 9.6 million deaths due to cancer were reported globally. According to the same source, around 70% of deaths from cancer occur in emerging economies with lung cancer accounting for the majority of deaths followed by breast cancer. Furthermore, according to the National Cancer Institute, in 2020, around 1,806,590 new cases of cancer are expected to be diagnosed in the U.S. with over 600,000 people dying from this disease. Such high incidence of cancer has led to increased demand for radiofrequency ablation devices. Hence, these factors are expected to drive growth global radiofrequency ablation device market during the forecast period. Furthermore, rising prevalence of cardiovascular disease combined with increasing number of ablation procedures is expected to boost the global radiofrequency ablation device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/radiofrequency-ablation-device-market.html

Osseointegration Implants are basically artificial implants that can be made of a plastic material that is designed to prevent the formation of new tooth structures in the jaw. The osseointegration implants are used to support prosthetic tooth replacement of various functionalities and designs. They replace anything from a single missing tooth to a full arch of teeth. These implants directly fuse with the bone and thus, they offer strength and durability to the new tooth. Generally, the replacement teeth are made to match with existing enamel color of each patient, thereby offering a completely natural appearance. The concept of osseointegration implants is that they help one heal their jaw from the inside out so that new tooth formations do not form anywhere near the damaged area. Apart from being used in dental implants, osseointegration implants are used in limb prosthesis for stable and improved walking and joint movement. These implants are directly connected to bones and therefore do not cause skin breakdown. Besides they feel like an extension of the natural body part. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/osseointegration-implants-are-proving.html

US-based medical diagnostics maker T2 Biosystems has signed six new agreements for the exclusive distribution of its diagnostic technologies in Estonia, Greece, Ireland, Saudi Arabia, and South Africa.

Launch of new products is expected to propel growth of the metabolomics market. For instance, in January 2021, JUNO Metabolomics launched the JUNO Viral Surveillance Platform based on its proprietary AI-Based Informatics System. Similarly, in June 2019, Bruker Corp. presented mass spectrometry and Nuclear Magnetic Resonance systems and other solutions for molecular phenomics and clinical metabolomics research at Metabolomics 2019. Moreover, increasing prevalence of chronic disorders is also expected to aid in growth of the market. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S. Integration of Artificial Intelligence (AI) with metabolomics is expected to offer lucrative growth opportunities for players in the metabolomics market. For instance, in July 2020, ReviveMed, an AI-driven drug discovery platform, collaborated with Bristol Myers Squibb for an AI-driven metabolomics study that will leverage ReviveMed's AI platform to better understand mechanisms of response and resistance to immunotherapies in patients with cancer. Moreover, increasing demand for metabolomics is also expected to aid in growth of the market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/integration-of-ai-with-metabolomics-and.html

One of the most popular brain supplements is called Brain Fitness Premium, which boosts the level of fatty acids in your brain. The fatty acids boost brain function by increasing blood flow to the brain and improving neurotransmitter levels, both of which are important to brain function. Other popular brain supplements include: Brain Power Plus, Brain Boosters, Ginkgo Biloba, and Hops Strawns. All of these ingredients are proven to help improve brain function and reduce the risk of Alzheimer's. Increasing prevalence of neurological disorders is expected to propel growth of the brain health supplements market. For instance, according to Alzheimer's Association, around 5.8 million people in the U.S. aged 65 and older are living with Alzheimer's dementia in 2020. Moreover, launch of new products is also expected to aid in growth of the market. For instance, in January 2020, InnerScope Hearing Technologies Inc. launched its new Brain Health & Dietary Hearing Supplement on Walmart.com. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/increasing-prevalence-of-neurological.html

Drug delivery means different methods, approaches, technologies, formulations, and systems for transporting a pharmaceutical compound in the body to achieve desired therapeutic effects. There are different types of drug delivery including intravenous injectable, inhalation, or absorption. The injectable drug delivery is considered the most effective route of administration for the effective delivery of drugs to the targeted sites. This enhances the patient's compliance with the drug. This method of drug delivery boosts the drug adsorption from various sites including intravenous, subcutaneous, and intramuscular. Moreover, it increases the bioavailability of the drug at the systematic circulation of the drug at the designated site of action. The challenges of administering an injectable drug to an area are unique and complex. It is common practice to inject a small amount of a drug into the skin of a subject in order to administer a larger dose. However, many complications could occur if too much of a drug is injected at once. Since most of these systems are designed to administer large amounts over a long period of time, multiple injections could cause serious health problems, such as infection and damage to vital organs. The future injectable drug delivery will require the development of new methods for delivering medications, and the creation of new products that provide a safer, more effective environment for the delivery process. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/injectable-drug-delivery-is-getting.html

Discover how our specialized services in Optical Revenue Cycle Management in New York can revolutionize your #healthcare financials. Learn about our expert Outsource Medical Coding Audit Services in the #US and Healthcare Provider Credentialing Services. Find out why healthcare providers selecting us for Revenue Cycle Management is the key to economic success.

Course "HIPAA for the Compliance Officer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why you should attend: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More im

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

Understanding Medical Identity Theft and ways of preventing it Medical Identity Theft is a common phenomenon in today's situation, where most health records are digitized. Although a lot of precaution goes into the security and protection of these records, Medical Identity Theft is a cause for worry. medicalIdentityTheft The most common types of data that are stolen are Social Security Number (SSN), name and the Medicare number, the most potent tools with which to impersonate and manipulate data. Why do crooks steal medical data? Medical Identity Theft happens mainly because hackers and mischief-makers access protected data to lay hands on confidential information about patients, using which they obtain medical care on behalf of the person/s whose records they steal or purchase expensive medicines. In many cases, a Medical Identity Theft is detected only after one gets a bill for a purchase or service that was never made. medicalIdentityTheft Medical Identity Theft is also committed to buy drugs and obtain fake bills that are then submitted to Medicare in the name of the original holder of the medical record. These acts can significantly dent a person's credit rating. More importantly, when wrong information or fictitious diagnosis is made into the medical record, it can lead to dangerous consequences. Ways of protection of medical data The Office of the Inspector General (OIG), which comes under Health and Human Services (HHS), realizing the gravity of the problem of Medical Identity Theft, has formulated the "3D" approach to protect medical data and prevent Medical Identity Theft. These are: Deter: One of the ways of protecting medical data is to prevent Medical Identity Theft. Users should be cautious about parting with information to anyone who claims, over phone, to have a new scheme whose enrolment requires the Social Security Number. Detect:Many fraudsters accost people at accessible public places to announce supposedly "new" medical schemes. Governm

Overview: Final regulations for the new HIPAA Breach Notification Rule require much more than notifying individuals affected by a Breach of their Protected Health Information (PHI). Covered Entities and Business Associates first must follow and document a very specific process to determine if a Breach occurred. If no Breach occurred documentary proof must be kept for six years. If a Breach did occur timely notifications and other actions must be undertaken and documented. This webinar will explain: What Covered Entities and Business Associates must do to comply with the Breach Notification Rule What is and is not a Breach Three exceptions - when an acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is not a Breach How to perform a Breach Risk Assessment to determine if you can demonstrate a a low probability that the PHI was compromised Who must be notified in case of a Breach When notifications must be provided What information must be contained in each notification Other requirements in case of a Breach Investigate Mitigate harm to affected individuals Protect against further Breaches Document everything Planning and preparation for the worst - public relations and mitigation strategies to limit damage to the organization's reputation and financial well-being Why should you attend: Breaches and incidents that might be Breaches happen all the time! More than 173,000 separate breaches of Protected Health Information (PHI) affecting less than 500 individuals were reported to the U. S. Department of Health and Human Services (HHS) between September, 2009 and May 31, 2015 and in the same period HHS received approximately 1240 reports of PHI breaches that affected 500 or more individuals An acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is presumed to be a Breach unless it falls within an exception or the Covered Entity or Business Associate can demonstrate a low probability that the PHI was compromi

Overview: This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also point out multiple court cases I have been affiliated with where a staff member of a hospital or clinic has been sued or even imprisoned! I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why should you Attend: Are you confused about HIPAA? Do you just want the basics and in plain English? Do you know there are civil and criminal penalties even for the rank and file staff member! Do you know what you can and can't do with protected health information? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence

Overview: This lesson will be going into great detail regarding your practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why should you Attend: HIPAA NOW HAS TEETH! Be prepared for what's new in 2016! Protect your practice or business! What factors might spurn a HIPAA audit? …are you doing these things? Why are the Feds enforcing after all these years? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk. Areas Covered in the Session: Updates for 2016 BYOD Portable devices B

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove