An understanding of Federal-Wide Assurances

The Federal-Wide Assurance (FWA) is an assurance given by an institution that is carrying out NIH-funded studies. Through this written assurance, which is required to be filed with the Office for Human Research Protections (OHRP); the institution commits itself to compliance with the terms of requirements set out in the HHS Protection of Human Subjects regulations at 45 CFR part 46. It is the only type of assurance that the OHRP accepts and approves.

The FWA must clearly outline the terms for reviewing, approving, and conducting a study. The FWA, which is to be signed by the Institutional Official, details the requirements that the institution that has filed such an agreement must uphold.

An essential element of the terms relates to written agreements for non-affiliated investigators and institutions. When a researcher works in a site or with an individual that is not currently governed by her home institution; the researcher is given the option of asking the non-affiliated site or individual to obtain a separate IRB approval or to request that her home institutional review board become the IRB of Record.

Grey areas of FWA’s

This, however, is a term that most investigators overlook. Almost invariably, when designing a study, investigators, who are too busy forming partnerships, gloss over important additional regulatory criteria such as these. At present, the trend is of conducting research in private physician offices and other community locations. This trend has come about mainly because of the advantage it brings: it makes research more accessible to potential participants. Yet, it calls for its own set of regulations and requirements.

There are many other grey areas that are particularly prominent and those that cause nagging problems to many investigators and their potential research partners. These include the written agreements required by the institutional review board (IRB), namely the Individual Investigator Agreement (IIA), IRB Authorization Agreement (IAA), and the Federal-Wide Assurance (FWA).

Since the terms of these agreements appear to be legalistic, they can intimidate both researchers and potential community partners. What are these? When are they necessary? Why are they necessary?

Proper learning on the unclear areas of FWA’s

It is to vital questions such as these that Sarah Fowler-Dixon, Education Specialist and instructor with Washington University School of Medicine, who has developed a comprehensive education program for human subject research which has served as a model for other institutions, will provide answers at a highly engaging webinar.

Being organized by MentorHealth, a leading provider of professional trainings for the healthcare industry; this highly informative webinar will clarify on the meaning and interpretation of FWA’s, what they are, and when they are needed.

Pleas register for this webinar and gain a proper understanding of Federal-Wide Assurances.

Sarah will offer insights into the regulatory ramifications of partnerships that overlook vital details, which will cause them frustration and could require them to carry out many actions such as providing additional information, gathering additional signatures, and explaining this regulatory requirement to their partners. Sarah will explain how to better explain the process to partners and thus save themselves these nagging issues.

Sarah will cover the following areas at this webinar:

• Federal-Wide Assurance
• Individual Investigator Agreement
• IRB Authorization Agreement
• When these agreements are used
• Why these agreements are used
• The process for establishing these agreements
• Are there other types of agreements that institutions may enter into, and how those would meet the regulatory framework?

This session is of high value to those involved in any important aspects of clinical research, such as Principal Investigators/Sub-investigators, Clinical Research Scientists (PKs, Biostatisticians), Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), Recruiting staff, QA/QC auditors and staff, Clinical Research Data managers, and Human Research Protection professionals.

 

Fill this form to get more updates

Preparing for HIPAA Enforcement

It goes without saying that preparing for HIPAA enforcement is of crucial importance to organizations. The reason: Last year saw a spike in the settlement payments ordered by HIPAA. There were as many as seven settlements of a value of over $1 million each. Of these seven, one was for $5.5 million, another was for $3.9 million, and yet another for $2.75 million. These constituted a part of a dozen or so overall resolutions settlements. These results point to the fact that HIPAA is continuing to crack the whip as far as enforcement is concerned. This calls for a greater level of vigilance and due diligence from Covered Entities and Business Associates in meeting HIPAA regulations on Protected Health Information (PHI).

HIPAA compliance is important for many other reasons

HIPAA compliance involves two main aspects: A) Making sure that the Covered Entity and the Business Associate provide the proper patient rights and controls on how they will use and disclose PHI; and B) Putting in place proper policies and procedures. These actions show the authorities that the CE’s and BA’s have all the necessary documentation in place for safeguarding patient PHI. They also demonstrate the way in which these entities addressed all required security safeguards if they are audited or become the subject of a compliance review.

Learning on how to ensure HIPAA compliance

How do organizations do this? How do they show the HHS that they have the right procedures and processes in place to ensure safeguarding of PHI? The answers to these questions will be provided at a webinar that MentorHealth, a leading provider of professional trainings for the healthcare industry, is organizing. Jay Hodes, who is President of Colington Security Consulting, LLC, which provides HIPAA consulting services for healthcare providers and Business Associates, will be the speaker.

In order to understand the proper and thorough means by which organizations can ensure the protection of health information and to ensure that they take all the steps necessary for preventing data breaches; please enroll for this webinar. Needless to say, a thorough and complete understanding of the fundamentals of HIPAA and the ability to explain and demonstrate the organization’s compliance program is the starting point for all these. The aim of this valuable learning session is to impart a clear and proper understanding of how healthcare practices, businesses, or organizations need to prepare given the increase in recent HIPAA enforcement and to make sure their current safeguards are adequate and can withstand government scrutiny. This course is approved for 1.5 general credits from the Nevada Board of Continuing Legal Education.

Learning for those involved in protecting patient health data

Anyone involved in PHI and other aspects of HIPAA implementation, such as Compliance Officers, HIPAA Privacy Officer, HIPAA Security Officers, Medical/Dental Office Managers, Practice Managers, Information Systems Managers, Chief Information Officers, General Counsels/Lawyers, Practice Management Consultants, or any Business Associates that accesses Protected Health Information and IT companies that support Medical/Dental Practices or other Healthcare organizations, will gain immensely from this session.

At this informative and interactive course, Jay will cover the following areas:

• Why was HIPAA created?
• What are the HIPAA Security and Privacy Rules?
• What is a HIPAA Risk Management Plan?
• What is meant by “Required” and “Addressable” Implementation Specifications?
• What are Administrative, Technical, and Physical Safeguards Requirements?
• What is a HIPAA Risk Assessment?
• What are HIPAA training requirements?
• How to prevent HIPAA data breaches from occurring
• What are the penalties and fines for non-compliance and how to avoid them?
• Preparing for increased enforcement HIPAA enforcement
• HIPAA Violation Case Examples
• Questions.

 

Bringing about positive changes into the US healthcare system

The American healthcare industry is a curious mélange. On the one hand, it is the world’s largest industry, with an estimated size of around $ three trillion. It is a system in which any treatment option that one can think of is available to the patient. Yet, it is characterized by a high degree of inefficiency and exorbitant costs. Many treatment options are out of reach of a large number of patients. It also suffers from non-implementation of many best practices that would have ensured a much better outcome for patients.

If the quality of care was proportionate to the size of the industry; the US healthcare industry should have been the world’s biggest not just in terms of the market size, but also in terms of quality. Quality is the core ingredient that is missing from the US healthcare industry. It fares poorly in comparison to even much less developed countries in the region, such as Cuba. As a result, the US healthcare industry is in a situation today where there is total mismatch between the high cost of healthcare and the quality of outcomes.

Rays of hope

There is hope, though. Two recent trends have aroused interest and promise that this scenario could change:

• The increasing shift by payers from traditional volume-based payment models to value-based payment models that reward efficiency and high quality
• The growing interest in translational science in transforming new research findings into improved practice, of which precision medicine is a notable example.

Adapting these and implementing them into a healthcare practice offers enormous scope for improvement of the system, but is not without its challenges. Healthcare providers need to show flexibility and gumption to come out of their traditional payment models, to which they have been accustomed for too long.

Explanation of these trends at a learning session

This interesting and highly useful topic will be discussed at length at a very interesting and interactive webinar that is being organized by MentorHealth, a leading provider of professional trainings for the healthcare industry. Dr. Maggie Gunter, Director of Medical Outcomes Research, Albuquerque, NM, who is an experienced and respected health services researcher and medical sociologist who was among the early innovators in disease management, case management, and use of data to evaluate and improve care and measure population health, will be the speaker at this webinar.

To hear Dr. Gunter’s insights into how a few techniques can go a long way in helping to transform the US healthcare industry, please register for this webinar

Good healthcare need not be expensive

Dr. Gunter will seek to destroy the myth that implementing high quality healthcare has to necessarily be expensive. She will explain key tools, techniques, and approaches that have been shown to be effective in helping providers improve care quality, outcomes, patient satisfaction and engagement, and also reduce costs. She will discuss a few successful models that have proved effective in different delivery settings and in bringing about behavior change for different target populations.

These models and techniques will serve as an important standpoint from which healthcare providers can make the difficult change from one reimbursement pattern to another. The ways in which they can be trained and assisted in these techniques will also be taken up, along with what roles major stakeholder groups, notably patients and consumers, play in identifying innovative solutions and hastening this transformation.

Addressing concerns from healthcare professionals

She will address concerns among many professionals in the healthcare industry about how to transition to the new payment system and lower costs to meet the emerging new goals of both federal and private payers and ways of complying with the new MACRA regulations that CMS is promulgating.

Dr. Gunter will take up the following areas at this session:

• Description of the current transformation of American medicine, including the current transition of U.S. health system reimbursement from traditional fee-for-service reimbursement to value-based reimbursement and the growth of translational science to enhance the spread of evidence-based practice
• What are the factors driving this change and how should providers and other stakeholders respond? (e.g., enormous variations in care outcomes, and costs across the nation, representing clear opportunities for improvement)
• Examples of health systems and programs which serve as successful models of high-quality, lower-cost care and the techniques they use to achieve these results (e.g., integrated systems, Project ECHO)
• Key factors in successful implementation in different healthcare settings and how the context influences the appropriate approaches
• Key steps in evidence-based practice
• Organizations available to help with training and quality improvement techniques at low or reasonable cost in response to the MACRA initiative from CMS (e.g., the regional CMS Quality Improvement Organizations).