Today’s Article on Understanding the HIPAA Privacy Rule, Security Rule and Breach Notification Rules and their compliance

The Health Insurance Portability and Accountability Act (HIPAA)’s Privacy, Security, and Breach Notification Rules are aimed at protecting the privacy, as well as the security aspects of health information. This set of rules has the intention of providing individuals with some rights on information relating to their health.

This is how the three rules need to be understood:

The Privacy Rule: Sets out standards about the conditions to be met for using and disclosing Protected Health Information (PHI). This Rule applies nationally.

The Security Rule: Specifies the kinds of safeguards that Covered Entities and Business Associates have to put in place and implement for protecting electronic Protected Health Information (ePHI) and ensure that they remain confidential and are made available when required, and have integrity.

The Breach Notification Rule: Covered Entities have to report breach of unsecured PHI to the affected individuals and the HHS. In some situations, this has to be reported to the media, as well. The Breach Notification Rule has details on how this is to be done. Generally, a window period of 60 days is given from the date of detection of the breach. Small breaches, meaning breaches that affect lesser than 500 individuals, may be directly reported to the HHS annually.

Purview of the HIPAA Privacy Rule and Security Rule

Privacy Rule: HIPAA Privacy Rule has standards on how to protect PHI held by the following: Health plans, healthcare clearinghouses, healthcare providers; part of whose healthcare transactions are carried out electronically, and Business Associates

Security Rule: HIPAA Security Rule sets out standards and guidelines on the steps that Covered Entities and Business Associates have to take to ensure that Protected Health Information is confidential, has integrity and is made available when needed. The Security Rule describes how these qualities in the ePHI created, maintained or transmitted by them.

Knowledge of all these aspects is very necessary if the Covered Entity or Business Associate has to ensure HIPAA compliance. The task of HIPAA compliance does not become possible with just a reading of the rules and the procedures. Expert advice on how to actually implement the requirements is needed.

This is what a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer. At this seminar, Jim Sheldon Dean, Director of Compliance Services, Lewis Creek Systems, LLC, will be the Director.

In order to gain complete understanding of the HIPAA Privacy Rule, Security Rule and the Breach Notification Rules, and to understand ways by which to ensure compliance with them in a way that satisfies the regulatory authorities, please register for this seminar by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900754?linkedin-SEO .

Jim Sheldon Dean will explain the requirements of HIPAA, how to prevent incidents, and how to survive audits, so that penalties can be avoided. He will offer an explanation of the background to HIPAA, and detail what a manager of healthcare information privacy and security has to know about the most important privacy and security issues. He will also show how to ensure HIPAA compliance, and explain the consequences of inadequate HIPAA compliance.

This seminar will provide in-depth understanding on the major aspects of HIPAA compliance, such as:

o  The new features of the regulations

o  The recent changes

o  The aspects that Covered Entities and Business Associates need to address if they have to remain compliant.

Learning on all aspects of HIPAA Privacy Rule, Security Rule and Breach Notification Rules

Jim will also explain audits and enforcements. He will also describe privacy and security breaches and explain how to avoid them. He will enrich the learning by providing sample documents and references.

Jim will cover the following areas at this two-day session:

o  Overview of HIPAA Regulations

o  HIPAA Privacy Rule Principles, Policies and Procedures

o  Recent and Proposed Changes to the HIPAA Rules

o  HIPAA Security Rule Principles

o  HIPAA Security Policies and Procedures and Audits

o  Risk Analysis for Security and Meaningful Use

o  Risk Mitigation and Compliance Remediation

o  Documentation, Training, Drills and Self-Audits.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/HIPAAPrivacyandSecurityTextOnly.pdf

GMPs for API Bulk Manufacturers

Till recently, till 2001 that is, Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) bulk manufacturers was carrying a bulky load on its shoulders, so to speak. GMP for active pharmaceutical ingredients (APIs) per se had no independent guidelines. The GMPs that they were to follow and implement were bunched with those of APIs for bulk manufacturers. So, GMPs for API bulk manufacturers consisted of GMPs for both APIs and API bulk manufacturer.

All that changed, however, in 2001, with the FDA’s issuance of a draft guideline called Q7A, which was meant separately and exclusively for APIs alone. This draft guideline was meant solely for APIs, and GMPs for API bulk manufacturers were exempt from the provisions of the new guideline.

No clear guideline yetThat said, while the FDA draft guidance of 2001 merely separated GMPs for APIs; it did not make any changes to the existing GMPs for API bulk manufacturers, which continued to remain the same and continued to suffer the same insufficiency. The major deficit that plagued GMPs for API bulk manufacturers continued to do so. As in the past, there was no guideline on GMPs for API bulk manufacturers at all. Instead, all that was required was that bulk manufacturers go by their heart. In other words, the onus of maintaining GMPs for API bulk manufacturers was left to them, based on their unique individual needs and situations.

Leaves it to the individual pharma organizationThe FDA and other regulatory bodies merely require that established practices be followed as GMPs for API bulk manufacturers. This, as noted, leaves the task of ensuring that conception and implementation of all-round GMPs for API bulk manufacturers to the individual organization, based on its discretion and assessment of what it deems as appropriate. The following are the areas into which pharmaceutical organizations may take steps at implementing GMPs for API bulk manufacturers:

  • Manufacturing equipment
  • Components that go into the materials and packaging
  • Requirements relating to record-keeping
  • Facilities and buildings
  • Personnel
  • Process controls
  • Laboratory controls

Learn more on this topic for your reference: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900964SEMINAR?Linkedin-SEO

Breaking down the rules into steps makes HIPAA compliance less complicated

HIPAA compliance is a legal requirement for Business Associates and Covered Entities. The Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996 with two main intentions:

o  To enable employees to keep their insurance intact when they switched jobs or their insurance provider

o  To facilitate the payment and information process by putting in place a uniform code for these.

From its start, up to 2013, HIPAA has undergone a few changes, such as:

o  The privacy regulation additions of 2003;

o  The insertion of the HIPAA Security Rule in 2005;

o  The passage of the HITECH Act in 2009, and

o  The addition of the Omnibus Rule in 2013, with the intention of extending liability to Business Associates

With the insertion of these additions, HIPAA compliance has become more and more demanding and complex, or at least that is what most entities who are required to comply with it feel. Most Business Associates and Covered Entities have issues with the following areas of HIPAA compliance:

–       The 18 identifiers that Protected Health Information (PHI) consists of; with the name, full face photos, e-mail address, and date of birth of the patients being some of their constituents

–       The requirement of designation, by every organization or practice, of a privacy officer, who has to carry out a risk analysis

–       The requirement, as part of HIPAA compliance, of covered health care providers and health plans, of developing and distributing a notice, in which the privacy rights and practices relating to patients’ personal health information have to be clearly explained.

Despite these requirements, HIPAA compliance is not as difficult as it seems

The reality, however, is different. HIPAA compliance is not as complicated and difficult as it is thought to be. At first glance, these requirements may appear to be intimidating. Yet, when it comes to practical application, HIPAA compliance is not really all that cumbersome or difficult. All that is needed is a clear-cut understanding and explanation of the major sections on compliance.

This clear-cut understanding of the major sections on which many Covered Entities and their Business Associates face difficulties is the intention of a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this detailed two-day seminar, Paul Hales, an attorney at law in St. Louis, Missouri who specializes in HIPAA Privacy and Security Rules, will be the Director. All that is needed to gain a thorough understanding of the perspectives Paul will offer on HIPAA compliance is to register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900798?linkedin-SEO .

What makes this seminar a valuable learning session is that Paul will explain, in simple and plain language, the contents of HIPAA compliance. He will demystify the tricky areas of HIPAA compliance and offer clarity of understanding of these, and will crystallize them into six easy steps.

Paul will drive home the point that HIPAA compliance becomes easier when its seemingly difficult requirements are broken down into steps. He will suggest six steps that organizations can take to make HIPAA compliance easier.

He will pack the seminar with visual presentations, interactive discussions and stimulating questions and answer sessions. He will also show how to find the right rule with the six step-by-step procedures he will lay down.

Takeaways at this important seminar on HIPAA compliance

Paul will offer these following key takeaways at this highly valuable seminar:

·        Thorough Understanding of HIPAA Rules

  • What they are
  • How they work together
  • Why and How they were made
  • How they are changing and what to expect next

·        HIPAA Risk Analysis – Risk Management for Your Organization

  • A Practical Guided Exercise done in class on your computer to take home

·        Privacy and Security Rules – Permitted and Required Uses and Disclosures

  • What information must be protected
  • Administrative, Technical and Physical Safeguards
  • Social Media, Texting and Emailing Patients

·        The inter-connected, inter-dependent relationship of Covered Entities and Business Associates

·        What is, and what is not a Reportable Breach of Unsecured PHI

http://www.fertilitybridge.com/blog/hipaaandsocialmediawithpaulhales

Article on Effective techniques for extracting information from geochemical data are largely ignored by the industry

In the area of geochemical data analysis techniques and obtaining geochemical extracting information; most mining specialists strongly recommend an approach that goes beyond merely asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis. There, however, exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information. But these are largely ignored by the industry.

As a result of following only one method and technique for geochemical data analysis and obtaining geochemical extracting information, an average geologist is not generally well trained on the necessary techniques and methods. Whenever a request for such data mining techniques analyses comes up, the geologist is short of the techniques and methods needed for geochemical extracting information, including the use of compositional data analysis. This results in failure in the endeavor of extracting all the geochemical data analysis information contained in the data.

Insight into how to use geochemical data analysis techniques and obtaining geochemical extracting information

Noting the deficiency in the methods used for optimal geochemical data analysis techniques and obtaining geochemical extracting information; GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, is organizing a two-day learning session that inculcates the right learning in this area.

At this seminar, Ricardo Valls, a professional geologist with thirty years in the mining industry, will be the Director. He brings the vast wealth of experience of the extensive geological, geochemical, and mining experience, managerial skills, research techniques, and training he has gained by carrying out various projects globally, into this seminar. To benefit from this seminar, please register for it by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900828?linkedin-SEO . This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Simplifying the geochemical extracting information to make sense

Geologists, Geochemists, Exploration personnel, Graduate students and Postgraduate students will find this course very useful, as it will give them an understanding of how to simplify and make sense of the geochemical extracting information. The speaker will demonstrate all types of analyses that can be requested. This will help participants in their exploration goal of finding the new ore body.

This seminar will help mining professionals understand how to extract all the important information of their data, including the use of compositional data analysis.

Valls will cover the following areas at this seminar on obtaining geochemical extracting information:

–       How to determine the type of sampling

–       How to determine the type of assays

–       General processing of the data

–       Compositional Data Analysis

–       Representing the results

In the process of explaining the ways of obtaining geochemical extracting information; Valls will set the following agenda for this seminar:

How to determine the type of sampling

·                    Mechanical anomalies

·                    Chemical anomalies

·                    Chemo-mechanical anomalies

·                    Scale of work

How to determine the type of assays

·                    What are you looking for?

·                    What the laboratory can offer?

QA&QC in the field and in the laboratory

·                    QA&QC in the field

·                    QA&QC in the laboratory

General processing of the data

·                    Preparing the data

·                    The problem of zeros and b.d.l. data

·                    Hurricane values

·                    Distribution law

·                    Preparing the data for further analysis.

Compositional Data Analysis

·                    Brief introduction

·                    Comparing CDa with normal statistics

·                    ALR

·                    CLR

·                    ILR

Processing major elements

·                    Statistical processing

·                    Determining the most probable magmatic event.

Processing trace elements

·                    Statistical processing

·                    Estimating the erosional level

·                    Determining geochemical indexes

Graphical representation of the results

·                    Variograms

·                    SURFER

Complaint Handling, Medical Device Reporting and Recalls

Complaint Handling, Medical Device Reporting and Recalls are important aspects of a medical device.

Complaint handling is a crucial element of any Quality System. If a complaint comes out from a user about a product after it has passed through FDA scrutiny, it is an indication that something needs to be looked at and that the complaint has to be addressed.

Putting in place an effective complaint handling system is an imperative for the medical device manufacturer and a requirement from the FDA. Complaints are an important indicator of the kind of products manufacturers release into the market. They are a very important standpoint from which devices are evaluated, investigated and analyzed, so that corrective action can be taken.

The complaint evaluation should serve as an indicator

A complaint handling system has to be put in place to help the manufacturer comprehend a gamut of issues concerning complaints. The validity of the complaint, the root cause of the complaint, and preventive action taken are important ones among these.

Look for the trend

Ignoring or glossing over complaints is something no medical device manufacturer that is serious about its business and is professional can afford to do. In fact, medical device manufacturers should look to complaints as being an important pointer of problems and issues with the design, use and/or manufacture of a product. It is possible that just one complaint that is fully investigated and properly handled could lead to corrective action from the manufacturer.

So, the trend is an important aspect of a medical device complaint handling system. The trend helps the manufacturer zero in on the specific cause for complaints. This, however, is not easy as it appears, because the medical device manufacturer may need to analyze a wide variety of complaints. It is only this comprehensive exercise that may sometimes lead to swooping in on a defect.

This exercise of spotting the trend is crucial for getting a hold of the precise locus of the problem in the Quality System. The trend could be anywhere ranging from the product to the labeling or to the packaging or its distribution.

Imparting understanding of Complaint Handling, Medical Device Reporting and Recalls

The important aspect of trend spotting in medical device recall and its associated aspects will be covered at an important learning session on this topic that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this two-day seminar, David R. Dills, Global Regulatory Affairs & Compliance Consultant who provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers, will be the Director. Full knowledge of all the aspects of medical device complaint handling can be gained by registering for this seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900758?wordpress_SEO for this.

The MDR and the Recall

David will also take up other important aspects of the medical device Quality System: The MDA and medical device recalls. The Medical Device Reporting (MDR) is the FDA’s mechanism that enables it to receive adverse events about medical device from manufacturers, user facilities and importers. The MDR system is aimed at helping the agency detect and correct adverse events quickly.

User facilities such as nursing homes and hospitals are required to report suspected medical device related serious injuries to the manufacturer and suspected medical device related deaths to both the FDA and the manufacturers. In cases where there is no information about the manufacturer, these injuries have to be reported to the FDA itself.

The FDA has an elaborate reporting system for all categories of medical devices, such as manufacturers, user facilities, distributors and manufacturers. David will offer learning on all these aspects of complaint handling.

The Medical Device Recall    

The Medical Device Recall is the method by which a medical device is taken out from the market and/or corrected whenever the FDA determines that the device, if it is left to continue in the market, has the potential to cause anything from serious and adverse health consequences to death. One can understand Medical Device Recall as an action taken with the intention of addressing a problem with a medical device that has violated applicable FDA law.

These are the situations in which Medical Device Recalls happen:

1) Because of a defect in a medical device;

2) The device’s potential to pose a risk to health, or

3) When it has a defect and is a risk to health.

David will offer clarity on all these aspects of Medical Device Recalls.

Applying ISO 14971 and IEC 62304 to medical device software

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Risk management of software used in medical devices has to be implemented diligently, completely and correctly, scrutinizing the gaps thoroughly and correcting them right from the very start of product development. This is critical because of the following reasons:

  1. Medical products that have gaps or are implemented incorrectly or incompletely suffer serious ailments such as impediments or delays in production. Further, such products fail to get the required certification and/or approval;
  2. Given the close linkage between most activities and the development lifecycle; almost no activity can be isolated and performed with retrospective effect after detection of a gap. As a result, all the activities performed till the identification of gaps become unproductive and redundant. When this happens, the company has to start from the beginning, irrespective of the stage at which an anomaly gets detected, incurring huge delays and cost overruns.

The solution to these problems is to embed software risk management into the bigger scope of overall risk management. This is the only real solution to problems associated with faulty product development. Globally applicable standard requirements such as ISO14971 and IEC62304 are major guidelines that help medical device companies get the risk management of software used in medical devices right. These standards have made risk management central to and a mandatory component of almost any activity in the medical device industry.

Getting it right from start till finish

Regulatory requirements set out in ISO14971 and IEC62304 standards that deal with risk management of software used in medical devices need to be implemented in the right manner, if medical device companies have to clear regulatory hurdles and meet quality standards. Expert professional trainings that help them do this will give them an understanding of how to design, implement and test critical medical device software in a regulatory compliant environment.

All these will be part of a learning session that is being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the regulatory compliance areas. This two-day, live seminar will have Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, as the course Director.

To gain the benefit of expert training from the Director of this seminar; please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900750?wordpress_SEO  to register.

Globally applicable standard requirements

Markus will explain the requirements set out by international consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, which has led to risk management being a mandatory component of almost any activity in the medical device industry.

Since the need to embed software risk management into the bigger scope of overall risk management is a critical aspect; Markus will introduce all the steps needed for designing, implementing and testing core medical device software in a regulatory compliant environment, even as they adhere to the principles of risk management. Another important learning Markus will impart is system level risk management and the resulting interfaces to software.

The safety case method

A well-established method for collecting and consolidating all safety related information together in one location, so that all risk related activities are comprehensively summarized, and the safe properties of a device demonstrated, is what is called the ‘Safety Case’ or ‘Assurance Case’ document.

Although as of now, the FDA requires this method for only infusion pump submissions; this system of documentation is almost certain to become standard practice in the future across all devices that come up for approval. At this course, Markus Weber will introduce the basic concepts and content of safety assurance cases. He will also explain and illustrate their utility for internal and external review of safety related information.

Tips for practical application of risk management principles

Real-life examples and proven tips and tricks that make the application of risk management practical and beneficial will be offered at this webinar. The Director will describe the system level issues of risk management as well as the increasingly important software related issues of critical systems.

He will introduce the concept of an assurance case to make the combined effort needed to design, implement and verify a safe device transparent. An important outcome of this learning is that it will help participants to meet and comply with regulatory requirements with highly lessened overheads and resource burdens.

Ensuring that analytical data in laboratories are accurate, reliable and consistent

Ensuring that analytical data are reliable, consistent and accurate is the fundamental reason for which analytical methods and procedures need to be validated. The employment of proper scientific methods and procedures by laboratories and validating them ensures the reliability, consistency and accuracy of the analytical data.

The purpose of doing so is to corroborate the suitability of intended use of a particular test and to confirm that the product produced in the laboratory meets the requirements of quality, purity, identity and strength in the required and set measure.

The imperative for validation of analytical data

The reason for which analytical data has to be validated for the criteria described above can be summarized in the following:

o  Because of the direct relationship it has to the quality of the data it validates;

o  To make sure that the analytical data is trustworthy;, and

o  Finally, validation, verification and transfer of analytical methods are a regulatory requirement, as set out by the different regulatory bodies such as the FDA and the EMA, and standards such as the USP and ICH.

Method validation and compendial methods

Of late, method validation has been receiving very high attention from both regulatory agencies and industry task forces alike. Both the FDA and the EMA have recently released guidelines on method validation and transfer. In addition, USP has suggested new chapters for approaches to the following:

o  Integrated validation

o  Verification and transfer of analytical procedures

o  Equivalency testing and for statistical evaluation.

What about compendial methods?

The verification of compendial methods is needed to demonstrate two aspects:

o  The suitability of laboratories to successfully run the method, and

o  To demonstrate through testing that transfer of methods, when carried on between laboratories, is successful. When a laboratory intends to use an alternative method in place of a compendial method, verification of compendial measures should establish the equivalency of the alternative method.

Comprehensive learning on validation, verification and transfer of analytical methods

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance will address all the issues relating to validation, verification and transfer of analytical methods. At this seminar, Ludwig Huber, the director and editor of Labcompliance, the global online resource for validation and compliance and highly respected author of several books on compliance, will be Director.

To gain the full knowledge of all areas relating to validation, verification and transfer of analytical methods; register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900858?linkedin-SEO .

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Contents of the two-day seminar

Over the course of these two days, Huber will equip participants with the background needed for getting a proper understanding of the requirements that need to go into validation, verification and transfer of analytical methods. An even more significant learning he will offer is the one on strategies needed for this.

He will provide tools to implement most critical requirements. Also provided are templates and examples for developing inspection-ready documentation. Interactivity will be a major component of this seminar. Huber will sprinkle workshop exercises into and between the presentations. Around half of the total time will be dedicated to practical sessions with real life examples.

An additional bonus for participants is the assortment of tools the Director of this seminar will offer, such as SOPs, validation examples and checklists, all of which will be made readily available on a dedicated website, and which can be used to easily implement the learning gained in the course.