HIPAA compliance expectations from Small Healthcare Providers

For The Health Information Portability and Accountability Act (HIPAA), the Business Associate is a major component. According to HIPAA, a Business Associate (BA) is an organization or a person who works with or provides service to a Covered Entity. A CE is one who handles or discloses Protected Health Information (PHI). This makes a Business Associate any person or entity that is involved in creating, receiving, maintaining or transmitting PHI to a CE for a purpose or activity or function as mandated and regulated by the HIPAA Privacy Rule.

Small businesses struggle with meeting HIPAA requirements

There are specific requirements that small healthcare practices need to put in place and to show that their program is current and meets the regulatory requirements set out in HIPAA. They need to conceive and implement a HIPAA compliance program that meets the requirements set out in this legislation. The compliance program should not only be adequate; it should be robust and resilient enough to withstand HIPAA’s strict scrutiny at various levels.

Helping small healthcare providers with the knowledge and skill needed for meeting HIPAA requirements is the purpose of a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. At this seminar, Jay Hodes, who is a leading expert in HIPAA compliance and President of Colington Consulting, which provides HIPAA consulting services for healthcare providers and Business Associates, will be the Director.

Want to get a complete understanding of the requirements that small healthcare providers need to meet to comply with HIPAA requirements? Just register for this learning session by visiting HIPAA compliance expectations from Small Healthcare Providers.

Full explanation of what all a small business provider needs to do

This seminar is particularly created for small healthcare providers who have a difficulty in understanding the HIPAA compliance requirements and meeting them. It will be useful for those of various business sizes, but is primarily focused on the small healthcare provider. Jay will impart the kind of teaching with which organizations will be able to meet all of the HIPAA, HITECH, and Omnibus Rules.

The basis to implementing the requirements of compliance program is to first fully understand them. This is the learning that this seminar will offer. At the end of two days of intense learning that will be interspersed with lively presentations; participants will have inculcated a full grasp of all of the requirements for a comprehensive HIPAA compliance program. They will also have got a clear understanding of the kind of steps that they need to take to mitigate risk.

Steps needed to develop, review and amend HIPAA

The Director will include practical exercises over these two days that will help participants know all that is needed for developing, reviewing, and amending HIPAA policy and procedure. He will equip the participants with a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations.

Over the two days, Jay will cover the following areas:

o  Why was HIPAA created?

o  Who Must Comply with HIPAA Requirements?

o  What are the HIPAA Security and Privacy Rules?

o  What are the Consequences of being a Business Associate

o  What is a HIPAA Compliance Program for a Business Associate?

o  What is a HIPAA Risk Management Plan?

o  What is a HIPAA Risk Assessment?

o  What is the Role of the HIPAA Security Official?

o  What are HIPAA training requirements?

o  What is a HIPAA data breach and what happens if it occurs?

o  What are the penalties and fines for non-compliance and how to avoid them

o  Case Examples of HIPAA Data Breaches

o  Creating a Culture of Compliance

o  Q&A.

Seminar Calendar of Upcoming Courses – June to July – 2017

Upcoming-Courses-for-French-Circles-Club

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

What Would Happen to Health Spending Under ACA?

The growth in health care spending is expected to have slowed in 2016 and to remain slow in 2017, due to slower enrollment in government-sponsored Medicaid and a reduction in spending on prescription drugs, according to a report released Wednesday by actuaries from the Centers for Medicare and Medicaid Services.

The report, published in the journal Health Affairs, assumes that President Barack Obama’s health care law, the Affordable Care Act, is still in place. Every year, the Office of the Actuary in the Centers for Medicare and Medicaid Services releases an analysis about how Americans are expected to spend money on health care in the years ahead. The agency will release the final outcomes on 2016 spending at the end of this year, once all the amounts have been tabulated.


RELATED CONTENT

Michelle Loose, a University of Denver accelerated nursing student, checks the blood pressure for patient Elife Bzuneh, during a medical clinic night at the DAWN clinic on August 9, 2016, in Aurora, Colorado.

Priced Out of Coverage


The effects of the Affordable Care Act are expected to dwindle in coming years. The report finds that if the law were to continue as is then the share of the insured population would increase from 90.9 percent in 2015 to 91.5 by 2025, as more people become employed in jobs that provide them with coverage.

The slowing of health spending growth by 1.1 percent to 4.8 percent in 2016 is expected to be short-lived as the U.S. population ages, with baby boomers going onto Medicare and likely needing to use more care. Because of these factors, beginning in 2018 both Medicare and Medicaid are projected to grow faster than private insurance spending as income growth slows.

“Irrespective of any changes in law, it is expected that because of continued cost pressures associated with paying for health care, employers, insurers and other payers will continue to pursue strategies that seek to effectively manage the use and cost of health care goods and services,” Sean Keehan, the study’s first author, said in a statement.

During a press conference in Washington hosted by Health Affairs, Keehan said that “high cost-sharing is certainly one of the important factors” in driving down how much people with private plans use care, given that they have to consider how much they will shoulder costs themselves in the form of out-of-pocket spending and deductibles.

By 2025, actuaries forecast that health care’s share of the economy will reach 19.9 percent, an increase from 17.8 percent in 2025.

According to authors of the Health Affairs article, “medical price growth is projected to quicken in the coming decade compared to recent history, as both overall prices and medical-specific price inflation grow faster.”

In 2014 and 2015, health care spending had accelerated because the Affordable Care Act’s provisions went into effect: Coverage was expanded to more people and more people used health care. The federal government also chipped in more to help people pay for premiums and to pay for Medicaid for low-income Americans. Prescription drug costs also are expected to slow. In 2014 and 2015, spending surged as the drugs that were approved to treat hepatitis C, a liver disease that can require a transplant if it turns into a chronic infection, hit the market.


RELATED CONTENT

Health and Human Services Secretary Tom Price, center, accompanied by his wife Betty, and Vice President Mike Pence, signs an official document during a swearing in ceremony, Friday, Feb. 10, 2017, in the in the Eisenhower Executive Office Building on the White House complex in Washington. (AP Photo/Andrew Harnik)

HHS Proposes Obamacare Rule


By 2016, these effects had slowed. Devin Stone, an economist in for CMS Office of the Actuary, said at the press conference that the projections assume that more drugs will lose their patents, slowing prescription drug costs as more generics become available.

Authors of the projections were forthcoming about the fact that the numbers are likely off target given that future of the Affordable Care Act is mired in uncertainty. Republicans and President Donald Trump have vowed to repeal the law, but lawmakers haven’t yet agreed on the timeline or ways to replace it. Decisions from lawmakers on both sides could alter factors around health spending but could also increase the number of uninsured, despite pledges or efforts not to.

Alan Weil, executive editor for Health Affairs, said the projections were still useful to help inform policy, particularly when it comes to designing ways to respond to the parts of the health care system that are driving price increases.

“This is a baseline and it’s still the law, so knowing where we are going is still important,” he said. “It’s also an important baseline to compare changes to the law. Whether we stick to the law or not, it’s important to know where we would have been.”

 

http://www.usnews.com/news/health-care-news/articles/2017-02-15/without-changes-to-obamacare-heres-what-happens-to-health-care-spending

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

 

 

Course “How to build a complete Safety, Health & Environment Management System through Standards & Practices” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Overview:

A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations.

A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own management systems, and the Safety, Health and Environmental, as well as Training and Security should have their own management system. This brings efficiency, consistency, cost effectiveness and timeliness to the entire process.

In order to work effectively, Corporate sets and creates (with business asset) input, the various standards around the functions

The SH&E, plus training and security are the functions we will build the standards and practices around. There are 16 functions that cover the SHE & TS world. We build a standard and practice around all 16 functions. Supporting documents, associated programs, procedures or standard operating procedures (SOP) will be a part of the particular function being managed. The 16 functions that will have a standard and practice specific to the function are:

  • Hazard identification & control
  • Occupational health & industrial hygiene
  • Incident management
  • Emergency preparedness
  • Environmental
  • Regulatory compliance
  • Reporting performance
  • Managing risk
  • Managing safety
  • Management security
  • Verification & audits
  • Document & record management
  • Contractor & service provider management
  • Competency management (training)
  • Commitment, communication and implementation
  • Managing change

Why should you attend :

Every organization in today’s business atmosphere, in order to be competitive and in compliance must have a comprehensive management system in place and operating smoothly. For those companies who do not understand this, the going is much harder and very much more expensive.

The standards and practices that are put in place act as the cornerstone for decisions being made relative to resources and dollars spent within the SH&E scope of business.

This process accomplishes the following:

  • Identifies the things that need to be managed within the function
  • Construct a process, tool, or mechanism that best manages each of those things identified
  • They are usually a set of standards, practices and programs that are built specifically for a particular function
  • Build the standard, practice or program so that it can be adjusted according to results
  • Build a measuring metric, benchmark or scorecard with both lagging and leading indicators
  • Build the management system in a way that is hierarchal in structure within the organization – (corporate sets and standards and the business unit builds the practice around the standard)

 

Areas Covered in the Session:

  • How to build a SH&E management system
  • How to evaluate its effectiveness
  • The tools you need in order to build a SH&E MS
  • How to implement the system with total management support
  • How to develop successful implementation plans, both with management and the workforce
  • How to tell the difference between a standard and a practice
  • How to understand how to design SH&E documents correctly
  • How to assess the risk of not having a MS process in place
  • How to roll the process out
  • How to communicate the process to those who can support the effort

 

 

Who will benefit:

  • EHS Managers, Directors, VP
  • Regulatory Managers
  • Compliance Managers
  • Production Managers, Directors, VP
  • Legal Managers
  • Quality Auditors
  • Operational Leaders (managers, directors, VP)

 

Agenda:

Lecture 1:

Process overview, Main elements of the SH&E MS, Process, infrastructure & system

Internal sources and External sources

What the regulatory agencies are looking for in a SH&E MS

Lecture 2:

System deficiencies

People, process & tools

Lecture 3:

The law perspective & risk analysis

Managing the risks through a systems approach

Lecture 4:

Non-conformance with expectations

Trending for results

Plan-Do-Check-Act

 

Day 2 Schedule

Lecture 1:

Process mapping tools

Creating the Standards & Practices (lots of examples)

Lecture 2:

Continue creating standards & practices

Lecture 3:

SH&E MS plan execution

Communicating the management system

Lecture 4:

SH&E documentation expectations

The MS review & approval process by management

Auditing the MS

How to roll it out – by stages

 

 

Speaker:

James Thatcher,

President, Global Safety Solutions, LLC,

 

James Thatcher the owner and President of Global Safety Solutions, LLC, headquartered in Divide, Colorado. Dr. Thatcher has 35 years of experience in the Oil and Gas, Metals/Minerals and Chemical industry, with management positions in engineering, operations, human resources, safety, health and environment, as well as training and security.

He has a MS in mechanical engineering, and a Ph.D. in psychology/organizational development. He has had many articles published in the Occupational Hazards Magazine, the VPP Leadership Magazine, IADC driller magazine, and through several organizations such as the National Safety Management Society and the World Safety Organization. He has presented at many seminars, summits, conferences, and association meetings for many years.

He is listed as an expert witness for operational as well as safety, health, environmental, training and security issues in the Oil and Gas industry and the mining, minerals and chemical industry. He is recognized in the Safety, Health, Environmental, Training and Security disciplines as an expert in these fields. He was the president of the National Safety Management Society for two terms, and is on their board of directors. He is closely associated with the World Safety Association, and is listed in the United Nations directory as an expert in the field of safety, health, training and security. He was the President of Technical Safety and Training Solutions, Incorporated, and consulted in the United States, Europe and South America.

I offer presentations for EHS conferences and summits, as well as for business group meetings in the area of EHS culture, values, systems, motivation, and inspiration. These messages are both timely and effective in helping to raise the bar in your EHS efforts.

 

 

 

Location: Baltimore, MD Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM

 

 

Venue: The DoubleTree Baltimore-BWI Airport

Address: The DoubleTree Baltimore-BWI Airport   890 Elkridge Landing Road – Linthicum, MD 21090

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,295.00 (Seminar Fee for One Delegate)

 

Until February 28, Early Bird Price: $1,295.00 From March 01 to April 04, Regular Price: $1,495.00

 

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

 

 

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

Registration Link –  http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900844SEMINAR?channel=mailer&camp=Seminar&AdGroup=wordpress_April_2017_SEO

 

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Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900774SEMINAR?linkedin-SEO

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900776SEMINAR?wordpress-SEO .  This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm