How to Manage a Product Medical Device Recall Efficiently and EffectivelyAnita Anzo
Scheduled On : Thursday, July 18, 2013 at 1:00 PM EDT
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
The Quality Payment Program offers a physician a choice of two paths for reimbursement:
The Merit-based Incentive Payment System (MIPS) Alternative payment models (APMs) which are further segregated into -Advanced and Non Advanced kinds.
Having an opportunity to engage with prospects and clients is something that I truly enjoy. As part of my day-to-day activities in business development and account management here at PolicyMedical, one of the questions that consistently comes up from prospective clients is “What are the advantages of policy management software for hospitals?”. To help answer that question, I have put together our very own Top Ten List.
How to Manage a Product Medical Device Recall Efficiently and EffectivelyAnita Anzo
Scheduled On : Thursday, July 18, 2013 at 1:00 PM EDT
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
The Quality Payment Program offers a physician a choice of two paths for reimbursement:
The Merit-based Incentive Payment System (MIPS) Alternative payment models (APMs) which are further segregated into -Advanced and Non Advanced kinds.
Having an opportunity to engage with prospects and clients is something that I truly enjoy. As part of my day-to-day activities in business development and account management here at PolicyMedical, one of the questions that consistently comes up from prospective clients is “What are the advantages of policy management software for hospitals?”. To help answer that question, I have put together our very own Top Ten List.
Connecting Access Governance and Privileged Access ManagementEMC
This white paper reviews why connecting a PAM solution to an IGA solution will enable organizations to holistically control and audit access to intellectual property, regulated information and infrastructure systems.
The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cell phones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide which healthcare app is safe?
The webinar discusses current regulatory expectation on how a firm identifies deviations, investigate the cause, recommend corrective, preventive actions.
How an Organization Can Elevate Compliance Standards360factors
A properly designed and effectively executed compliance program is critical for enhancing and validating company performance and reducing compliance risk. However, the efficacy of a compliance program depends on whether it is a paper program or is integrated within the company and used almost daily.
To elevate compliance standards, organizations can follow the below-mentioned practices:
• Understand the Requirements
• Identify and Assess Compliance Program
• Create Transparency
• Ensure Operational Compliance
• Resolve Problems and Issues
For more details: https://bit.ly/3REefMr
The Department of Health and Human Services (HHS) developed an interactive Security Risk Assessment Tool (SRA Tool) to help covered entities perform and document HIPAA security risk assessments. Although the SRA Tool was designed for health care providers, it is a helpful resource for all covered entities, including health plans and business associates. This Compliance Overview provides an summary of the SRA Tool and includes links to the tool and additional resources.
Privacy and Security What types of health care data are protected u.pdfbadshetoms
Portia Grant is an employee who is paid monthly. For the month of January of the current year,
she earned a total of $8,260. The FICA tax for social security is 6.2% of the first $118,500
earned each calendar year and the FICA tax rate for Medicare is 1.45% of all earnings. The
FUTA tax rate of 0.6% and the SUTA tax rate of 5.4% are applied to the first $7,000 of an
employee’s pay. The amount of federal income tax withheld from her earnings was $1,325.17.
What is the total amount of taxes withheld from the Portia’s earnings? (Round your intermediate
calculations to two decimal places.)
A- $3,097.17
B- $2,443.21
C- $1,957.06
D- $1,722.00
E- $1,495.36
Solution
The Answer is “C- $1,957.06”
Total amount of taxes withheld from the Portia’s earnings = $1957.06
Total amount of taxes withheld = Federal Income Tax + FICA tax for social security + FICA tax
rate for Medicare
= $1,325.17 + [ $8,260 x 6.20%] + [$8,260 x 0.60%]
= $1,325.17 + 512.12 + 119.77
= $1,957.06.
Better known as the Health Insurance Portability and Accountability Act, HIPPA law has been initiated to achieve consumer protection in 1996. HIPPA protects customers from theft, financial scams, fake transactions, and also prevents exploitation or injustice done to customers while they are opting for healthcare facilities or for certain policies.
Connecting Access Governance and Privileged Access ManagementEMC
This white paper reviews why connecting a PAM solution to an IGA solution will enable organizations to holistically control and audit access to intellectual property, regulated information and infrastructure systems.
The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cell phones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide which healthcare app is safe?
The webinar discusses current regulatory expectation on how a firm identifies deviations, investigate the cause, recommend corrective, preventive actions.
How an Organization Can Elevate Compliance Standards360factors
A properly designed and effectively executed compliance program is critical for enhancing and validating company performance and reducing compliance risk. However, the efficacy of a compliance program depends on whether it is a paper program or is integrated within the company and used almost daily.
To elevate compliance standards, organizations can follow the below-mentioned practices:
• Understand the Requirements
• Identify and Assess Compliance Program
• Create Transparency
• Ensure Operational Compliance
• Resolve Problems and Issues
For more details: https://bit.ly/3REefMr
The Department of Health and Human Services (HHS) developed an interactive Security Risk Assessment Tool (SRA Tool) to help covered entities perform and document HIPAA security risk assessments. Although the SRA Tool was designed for health care providers, it is a helpful resource for all covered entities, including health plans and business associates. This Compliance Overview provides an summary of the SRA Tool and includes links to the tool and additional resources.
Privacy and Security What types of health care data are protected u.pdfbadshetoms
Portia Grant is an employee who is paid monthly. For the month of January of the current year,
she earned a total of $8,260. The FICA tax for social security is 6.2% of the first $118,500
earned each calendar year and the FICA tax rate for Medicare is 1.45% of all earnings. The
FUTA tax rate of 0.6% and the SUTA tax rate of 5.4% are applied to the first $7,000 of an
employee’s pay. The amount of federal income tax withheld from her earnings was $1,325.17.
What is the total amount of taxes withheld from the Portia’s earnings? (Round your intermediate
calculations to two decimal places.)
A- $3,097.17
B- $2,443.21
C- $1,957.06
D- $1,722.00
E- $1,495.36
Solution
The Answer is “C- $1,957.06”
Total amount of taxes withheld from the Portia’s earnings = $1957.06
Total amount of taxes withheld = Federal Income Tax + FICA tax for social security + FICA tax
rate for Medicare
= $1,325.17 + [ $8,260 x 6.20%] + [$8,260 x 0.60%]
= $1,325.17 + 512.12 + 119.77
= $1,957.06.
Better known as the Health Insurance Portability and Accountability Act, HIPPA law has been initiated to achieve consumer protection in 1996. HIPPA protects customers from theft, financial scams, fake transactions, and also prevents exploitation or injustice done to customers while they are opting for healthcare facilities or for certain policies.
Using Clinic Management Software to ensure compliance management.pptxMocDoc
Discover the importance of compliance management in healthcare and how Clinic Management Software (CMS) plays a vital role in ensuring adherence to regulations. Streamline operations, protect patient data, and enhance efficiency with CMS. Read more to elevate your clinic's compliance and efficiency.
Prepare a workplace brief (8-10 double-spaced pages) to address a .docxharrisonhoward80223
Prepare a workplace brief (8-10 double-spaced pages) to address a privacy breach that occurred in a health care organization. Include the consequences of failure to act and evidence-based recommendations for addressing the breach.
Introduction
Health care is one of the most heavily regulated major industries in the United States. Leaders are challenged to stay current and to comply with federal, state, and local laws and their associated regulations. Health care organizations are also responsible to meet industry standards. In some cases, payers equate meeting industry standards with achieving and maintaining accreditation. In fact, many payers consider accreditation a minimum condition of participation. In addition, individual licensure and certification requirements establish basic expectations for health care leaders' professional conduct.
In summary, health care leaders are responsible to:
1. Meet ethical personal, professional conduct, certification, and licensure expectations.
2. Comply with local, state, and federal health care and human resources laws.
3. Provide evidence of compliance with existing regulations and scan the field for emerging regulations.
4. Identify and meet appropriate accrediting body standards (for example, Joint Commission’s National Patient Safety Goals standards).
As an individual’s health care leadership career advances, so does the corresponding level of accountability. Not knowing the laws or regulations is not an excuse for not complying with them.
This assessment allows you to demonstrate your knowledge of and skills relating to compliance concepts, and governmental and regulatory agencies that oversee health care service delivery, billing, and general operations. You will also have the opportunity to apply the components necessary to initiate and maintain an effective compliance program. Finally, you will consider relevant human resources laws that may pertain to your compliance recommendations.
Instructions
In this assessment, you are assuming the role of an early careerist in risk management and quality improvement at one of Vila Health's community-based hospitals. Vila Health is a medium-sized system of health operating facilities in Minnesota and Wisconsin. You are working on a team-based initiative under the supervision of the Vila Health Chief Compliance Officer. Your role is to assist in addressing a specific compliance risk regarding a breach of privacy and a potential HIPAA violation. A Vila Health employee has disclosed—without prior written authorization—a patient's protected personal health information.
Here is the information the team has collected about the privacy breach and potential HIPAA violations to date. A Vila Health supervisor instructed an employee to obtain pre-authorization for an upcoming surgical procedure for a patient. The Vila Health employee submitted confidential, protected health care information about the patient to the insurance company. The Member Services Representati.
In this ptresentation i have talked about corporate compliance program Specially Endo Pharmaceuticals corporate compliance program. Here is discussed about Some external government requirements related to compliance, Elements of an Effective Compliance Program, Corporate Compliance & Business Practices, Endo's Culture of Compliance, Leadership responsibilities, Code of Conduct, Reporting a Concern, Findings from corporate compliance. We have also recommended for overcoming some drawbacks related to corporate compliance to do so they will have to make the corporate compliance more effective & more motivational & more efficient. The study is performed based on the information extracted from different sources collected by using a specific methodology. This report is analytical in nature. To prepare the report on corporate compliance policy and procedure of Endo Pharmaceuticals. The information has been collected from secondary sources.
Chapter 22
Medicare Advantage
Learning Objectives
Operations of Medicare Advantage Organizations (MAO’s)
Responsibility for “FDR entities”
Guidelines for mandatory MAO compliance program
Compliance Officer and Compliance Committee
Agenda of a good compliance training effort
Value of open lines of communication
Effective disciplinary standards
Audits and monitoring to evaluate compliance
Program exclusions and self-reporting
Introduction
MAO’s are managed care organizations for Medicare beneficiaries. There are 3,500 MA plans serving 12 million beneficiaries – 25% of the total.
Compliance programs are mandatory for MA plans. Although the OIG has issued a Compliance Program Guidance for MAO’s, the primary authority on MA compliance is the Medicare Managed Care Manual (Chapter 21 of the Compliance Program Guidelines).
7 Basic Elements of a Mandatory Compliance Program for MA Plans
Policies, Procedures, and Standards of Conduct
Compliance Officer, Compliance Committee, and High Level Oversight
Effective Training and Education
Effective Lines of Communication
Well-Publicized Disciplinary Standards
System for Routine Monitoring and Auditing
Prompt Response to Compliance Issues
FDR Entities
MAO: Plan Sponsor
F: First Tier Entity
D: Downstream Entities
R: Related Entities
FDR entities may be a sources of compliance problems.
MAO’s must work with those entities to prevent and resolve the problems.
Delegating Compliance to FDRs
Plan Sponsors may enter into contracts with FDRs to provide administrative or health care services to their enrollees.
They may not delegate compliance program functions to them.
Activities that Sponsor may delegate to a FDR entity, but remains responsible for them.
Factors in determining which contractors are FDRs.
Policies, Procedures, and
Standards of Conduct
Code of Conduct – defines ethical, compliant behavior for employees and FDR’s
Policies and procedures – tell employees and FDR’s how to perform their work tasks in conformity with laws and payor requirements
Emphasis is on areas of high compliance risk as identified by the organization and OIG
Important to impose comparable policies and procedures on FDR’s
7
Compliance Officer, Compliance Committee, & High Level Oversight
Compliance Officer – full-time, report to CEO, final authority on compliance matters, overall management of compliance program
Specific duties, powers, and status within the organization
Compliance Committee – composition, list of responsibilities
Governing board – oversight of compliance efforts and program effectiveness
Effective Training and Education
Two types of mandatory training – General and Fraud, Waste, and Abuse (FWA).
Annually, part of new employee orientation.
Agenda for each type of training.
Training for employees, managers, governing board, FDR’s, temp workers, & volunteers
Various methods of delivery
Proof that training was delivered
Effective Lines of Communication
Between the CO and CC, and employees ...
HIPAA Compliance Testing In Software Applications.pdfZoe Gilbert
Read this article to gain a basic understanding of the significance of HIPPA compliance for the healthcare industry.
Our healthcare testing services acknowledges the challenges, consider ways to give patients more control over their health information, and implement security measures to guarantee that the privacy of patient information is safeguarded by healthcare practitioners and others.
HIPAA-Compliant App Development Guide for the Healthcare Industry.pdfSuccessiveDigital
This is an article about HIPAA-compliant app development for the healthcare industry. It discusses the importance of HIPAA compliance and the risks of non-compliance. The article also outlines the steps involved in developing a HIPAA-compliant app. Some of the important points from this article are that HIPAA compliance is an ongoing process and that there is no certification required to build a HIPAA-secure app.
How HIM Supports the Seven Elements of an Effective Compliance ProgramPYA, P.C.
•An understanding of the seven elements of a robust compliance program.
This presentation offers a review of the regulatory guidance surrounding compliance programs, an identification of HIM’s role in organization compliance, and a discussion of the intersection between HIM and compliance.
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
QA Paediatric dentistry department, Hospital Melaka 2020Azreen Aj
QA study - To improve the 6th monthly recall rate post-comprehensive dental treatment under general anaesthesia in paediatric dentistry department, Hospital Melaka
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
3. Purpose of compliance:-
The Purpose of a Corporate Compliance Program
A corporate compliance program is a formal system to help your organization maintain compliance in all
areas of operation. The program will focus on upholding policies and procedures that prevent the
organization and employees from breaking laws and regulations.
key functions of a compliance department:-
A compliance department typically has five areas of responsibility—
Identification
Prevention
Monitoring
Detection
Resolution
Advisory
A compliance department identifies risks that an organization faces and advises on
how to avoid or address them.
4. Healthcare Compliance:-
Tools, expert guidance, and education to help healthcare compliance
and auditing professionals keep their organizations in compliance with
federal and state laws and regulations. Practical strategies to ensure
appropriate reimbursement and prevent violations of the False Claims
Act,
HIPAA(Health Insurance Portability and Accountability Act), HCCA(Health Care
Compliance Association
),GDPR(General Data Protection Regulation)
5.
6.
7. Salesforce healthcare customers, protecting patient data is a shared responsibility.
Salesforce secures customer data hosted on its platform, and developers and
admins configure the platform to meet their company’s and customers’ needs.