Supply Chain Integrity and Security

Supply Chain Integrity and Security

The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our attention to supply chain integrity and deal with both security and integrity concurrently.

An Oxford on-line dictionary definition of integrity is “the state of being whole and undivided”. Over the last 40 years, the Pharma supply chain has fragmented to the point where it is a million miles from that state. There are now multiple business models, such as virtual, biotech, specialty Pharma, innovator, generics, biosimilars, etc and a divergence of supporting actors, such a contract manufacturing organizations (CMOs), contract research organizations (CROs), central laboratories, third party logistics providers, pre-wholesalers, wholesalers, specialty pharmaceutical providers (SPPs) etc. As a result, our supply chains have dis-integrated to the point where visibility and accountability have become blurred at the edges – and it is this disintegration that has opened the doors to criminal activity and errors in quality outcomes.

The solution is not an easy one. It requires urgent action to mitigate activities of the ‘bad guys’, together with a longer term approach to ensure the ‘good guys’ get better at building and managing robust supply chains. This can only be achieved by collaboration between regulators, other enforcement agencies, technology providers and the industry itself. Where do we start?

We must initially focus on the end-to-end supply chain in its current state. Chains of custody and ownership must be clearly identified and remediation actions agreed by responsible parties to plug the gaps that currently exist. For example, Quality and technical agreements must become far more ‘process’ orientated so that they become working documents shared between business partners, rather than merely a static list of tick boxes. Change control has to work on upstream and downstream impacts that might affect supply chain integrity and procurement must forge supply agreements that impose obligations for supply chain visibility on prospective partners. This and much more needs to happen and will be discussed in the session.

Then we must turn attention to the building of supply chains for the future – the product development phase. This industry is unique in that the entire supply chain must be registered with competent authorities before approval to sell and post-launch changes have to be approved. This places a great responsibility on getting it right from the start. This is where the opportunity lay for sustainable improvements in the physical architecture of the supply chain and the underpinning management processes and information flows. A foundation for this has already been put in place by the regulators through FDA’s 21st Century Modernization initiative and ICH Q8 – 11 guidelines. The key to translating these initiatives into meaningful supply chain improvements, however, it in understanding the patient value proposition and the organizational/cultural elements that must firstly be in place, and these are explored in some depth.

Why should you attend: The Pharmaceutical supply chain has never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Cargo theft, diversion and counterfeiting have become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.

Areas Covered in the Session:

  • How to organize for supply chain integrity throughout the product life cycle
  • Current approaches to clamping down on criminal activity in the supply chain
  • Issues causing greatest concern to regulators and how to address them
  • Role of ICH Q8 – 11 in building robust supply chains
  • How the disciplines of procurement and supply chain management (SCM) can be leveraged
  • Role of technology as an enabler

Who Will Benefit:

  • Research chemistry and biochemistry
  • Chemical and biochemical engineering
  • Chemistry, manufacturing, and controls
  • Preclinical Development
  • Clinical Development
  • Regulatory Affairs
  • Quality Assurance

Speaker Profile

Hedley Rees is a practicing consultant, coach and trainer, helping healthcare companies build, manage and continuously improve their clinical trial and commercial supply chains and risk profiles. He has his own company, Biotech PharmaFlow Ltd, based in the UK and handles assignments across the spectrum from top ten Pharma’s through to highly virtual early stage start ups. Prior to this, Hedley held senior supply chain positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of supply chain management processes from strategic procurement, production and inventory control, distribution logistics, information systems and improvement. His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernization and ICH Q8 – Q10.

Hedley holds an Executive MBA from Cranfield University School of Management and is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS). He is a member of the UK BioIndustry Association’s (BIA) Manufacturing Advisory Committee and also regularly speaks at international conferences, being co-chair of the 2011 FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati, October 2 -5. He has published in US and EU pharmaceutical journals and is author of “Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics” published by J. Wiley & Sons, Hoboken, New Jersey.

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Seminar on HIPAA 2019 | HIPAA Security Risk Assessment | What’s new?

Description:

This two-day seminar will get into the fine details of what we need to do and how to do it.

We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA – I want to add clarity for compliance officers

It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Why you Should attend:

Join me in this two day seminar to explore what’s new with HIPAA both from a regulation standpoint (new requirements) and an enforcement standpoint

Omnibus has changed the HIPAA landscape for good!

Do you know all of the requirements of this enigmatic law?

Are you abiding by them?

My goal is to make this extremely complex enigma known as “HIPAA” very easy to understand with a painless step by step approach to an otherwise harrowing task… Times have changed and new laws are now in place concerning protected health information. The best way to protect your practice or business and save yourself future headaches and possible litigation or Federal fines is to be proactive instead of reactive

This once rarely enforced law has changed and you need to know what’s going on!

Protect your practice or business!

 

Areas Covered in the Session:

Study all 18 Standards and 44 Implementation Specifications of the regulations

Updates for 2019

Requirements of Compliance Officers

New definition of what constitutes protected health information

Real life litigated cases

BYOD

Portable devices

Business associates and the increased burden

Emailing of PHI

Texting of PHI

Federal Audit Process

HIPAA and suing – how this works

Risk Assessment

Who Will Benefit:

Practice managers

Any business associates who work with medical practices or hospitals (i.e. billing companies, transcription companies, IT companies, answering services, home health, coders, attorneys, etc)

MD’s and other medical professionals

Agenda:

Day 1 Schedule

Lecture 1:

HIPAA a Brief History

Lecture 2:

HIPAA Privacy vs Security

Lecture 3:

New definition of what constitutes protected health information

Lecture 4:

HIPAA and the Business Associate

Lecture 5:

Through examination of all 18 Standards and 44 Implementation Specifications of the HIPAA Security Rule and how to apply them

Lecture 6:

How to enforce policy for each standard and implementation specification

Lecture 7:

HIPAA and litigation

Day 2 Schedule

Lecture 1:

The Federal Audit Process and things to be ready for

Lecture 2:

HIPAA and Suing – how this works and examples of real cases

Lecture 3:

Technology and HIPAA – best practices and big “no-no’s”

Lecture 4:

Ransomware, Viruses, bad technology

Lecture 5:

HIPAA Texting and Emailing – myth vs reality

Lecture 6:

Personal Devices and HIPAA

Lecture 7:

HIPAA and the Audit Process

Lecture 8:

How to conduct a HIPAA Security Risk Assessment

Speaker:

Brian L Tuttle

ex-FDA Expert and former Associate Center Director of CDRH

Brian L Tuttle is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified HIPAA Administrator (CHA), Certified Business Resilience Auditor (CBRA), Certified Information Systems Security Professional (CISSP) with over 18 years’ experience in Health IT and Compliance Consulting.

With vast experience in health IT systems (i.e. practice management, EHR systems, imaging, transcription, medical messaging, etc.) as well as over 18 years’ experience in standard Health IT with multiple certifications and hands-on knowledge, Brian serves as compliance consultant and has conducted onsite and remote risk assessments for over 1000 medical practices, hospitals, health departments, insurance plans, and business associates throughout the United States.

Location: Miami, FL Date: April 18th & 19th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  Hyatt Place Miami Airport East, 3549 NW 42nd Ave, Miami, FL 33142, USA

Price:

1 ATTENDEE $2,000, Register for 1 attendee

5 ATTENDEES $10,000, Register for 5 attendees

10 ATTENDEES $20,000, Register for 10 attendees

Until March 10, Early Bird Price: $2,000.00, From March 11 to April 16, Regular Price: $2,200.00

Sponsorship Program benefits for seminar

For More Information

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NetZealous LLC DBA GlobalCompliancePanel

globalcompliancepanel@gmail.com

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Virtual Seminar on HIPAA Training for Compliance Officer

This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do’s and don’ts with HIPAA -I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors.

We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations

I will also speak to real life litigated cases I have worked where HIPAA is being used to justify state cases of negligence -THIS IS BECOMING A HUGE RISK!

In addition, this course will cover the highest risk factors for being sued as well as being audited (these two items tend to go hand in hand).

Why you should attend

Join me in this in depth 6-hour seminar where we will get into the nitty-gritty about the roles and responsibilities of a HIPAA Compliance Officer.

Do you have an affective HIPAA compliance program? Do you know what needs to be done to satisfy the requirements?

New laws, funding, and enforcement mean increased risk for both business associates and covered entities – 2017 was a record year for enforcement and fines – 2018 will be no different.

HIPAA Omnibus – Do you know what’s involved and what you need to do?

What does Omnibus mean for covered entities and business associates?

Why should you be concerned?

Court cases that are changing the landscape of HIPAA and patient’s ability to sue!

TRIAL ATTORNEYS ARE MORE DANGEROUS THAN THE FEDERAL GOVERNMENT!!

It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates. You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT or internal administrative practices.

Who Will Benefit

  • Practice Managers
  • Any Business Associates who work with medical practices or hospitals (i.e. billing companies, transcription companies, IT companies, answering services, home health, coders, attorneys, etc)
  • MD’s and other medical Professionals

Agenda

  • Updates for 2019
  • Requirements of Compliance Officers
  • New definition of what constitutes protected health information
  • Real life litigated cases
  • BYOD
  • Portable Devices
  • Business associates and the increased burden
  • Emailing of PHI
  • Texting of PHI
  • Federal Audit Process
  • HIPAA and suing – how this works
  • Risk Assessment
  • Ransomware and how to avoid
  • What to do when a breach occurs
  • Best Resources

Speaker Profile

Brian L Tuttle, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 15 years’ experience in Health IT and Compliance Consulting. Mr. Tuttle has worked all of those 15 years with MAG Mutual Healthcare Solutions and is now Senior Compliance Consultant and IT Manager with InGauge Healthcare Solutions (previously named MAG Mutual Healthcare Solutions). Almost all of Brian’s clients are earned by referral with little or no advertising. Brian is well known and highly regarded in medical circles throughout the United States .

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A to Z’s of HIPAA Privacy, Security, and Breach Notification Rules

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them.

It is designed to provide intensive, two-day training in HIPAA compliance, including what’s new in the regulations, what’s changed recently, and what needs to be addressed for compliance by covered entities and business associates.

It provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

Benefits from this Rules:

  • Information Security Officers
  • Risk Managers
  • Compliance Officers
  • Privacy Officers
  • Health Information Managers
  • Information Technology Managers
  • Medical Office Managers
  • Chief Financial Officers
  • Systems Managers
  • Legal Counsel
  • Operations Directors

HIPAA Privacy Rule Principles, Policies and Procedures

  • Patient Rights under HIPAA
  • Limitations on Uses and Disclosures
  • Required Policies and Procedures
  • Training and Documentation Requirements

Recent and Proposed Changes to the HIPAA Rules

  • New Penalty Structure
  • New HIPAA Audit Program
  • New Patient Rights
  • New Obligations for Business Associates

Go through here for detailed rules

200+ followers. WOWWWWWW…

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Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Internal Audit Checklist for HIPAA

Internal Audit Checklist for HIPAA.jpg

The internal audit checklist for HIPAA is one of the primary elements of HIPAA implementation. The passage of the Health Insurance Portability and Accountability Act (HIPAA) by the U.S. Congress in 1996 was aimed at regulating the way and process by which healthcare institutions across the country reveal the medical information of their patients.

The Department of Health and Human Services (HHS) is tasked with monitoring the compliance aspect of the law, i.e., it monitors how medical organizations comply with the provisions of HIPAA. In order to ensure that medical organization stay compliant with the provisions of HIPAA; auditors measure these compliance aspects with a checklist when testing companies’ medical data recording processes.

The internal audit checklist for HIPAA, like any other checklist, is a list of do’s and don’ts that a healthcare organization has to look to see if it is complying with its processes relating to medical data sharing and recording. These are the core areas against which auditors prepare and monitor the internal audit checklist for HIPAA:

Analysis and assessment of risk

Internal Audit Checklist for HIPAA3

One of the foremost aspects of the internal audit checklist for HIPAA is the organization’s analysis and assessment of the risk involved in disclosing medical information. Medical organizations of the designated types have to carry these out at regular, periodic intervals in ensuring that they don’t give opportunities for causing data breaches. Since healthcare organizations are involved in collecting, keeping and transferring of medical information; it is necessary for them to keep analyzing and assessing the risk involved in data breaches.

Gap analysis

In this category of internal audit checklist for HIPAA; auditors compare regulatory guidelines to security systems in the corporate sector. The idea is to help the medical organization outline its security requirements vis-a-vis its security infrastructure

Remediation

Internal Audit Checklist for HIPAA4

In this internal audit checklist for HIPAA; the healthcare organization relies on a number of technologies and steps to prevent any breach of data, and to also offset the damage done when a breach happens. The primary tools used in this internal audit checklist for HIPAA include software used for tracking defects, for process reengineering, CRM and a few ERP applications.

Planning for contingencies

An internal audit checklist for HIPAA also includes a set of plans that the healthcare organization has to have to be able to plan for contingencies. A healthcare organization can expect emergencies or disasters from any source, and these can be of any kind. An internal audit checklist for HIPAA should include plans for anticipating and dealing with these.

Personnel policies

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The policy a healthcare organization puts in place for its personnel is an important point in the internal audit checklist for HIPAA. It has to decide what kinds of trainings its staff members receive for implementing HIPAA compliance.

 

 

 

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Las Vegas hospitals must follow regular HIPAA privacy rule

Las Vegas hospita.jpg

After natural disasters, HHS sometimes waives certain HIPAA privacy rule requirements. That’s not usually the case after man-made disasters, such as Sunday night’s massacre in Las Vegas, where more than 50 were killed and hundreds were wounded after a gunman opened fire at a music festival.

Because the HIPAA privacy rule already allows information disclosure in certain cases, such as when public safety is threatened, and because there has been no declaration of a public health emergency, HIPAA waivers have not been necessary in this case.

Local hospitals will have to be careful, especially with so many requests for information from families, friends, and the media, said Mark Swearingen, a Hall Render attorney focused on health information privacy and security.

“Hospitals are going to have to be very careful about vetting and authenticating the individuals who might be calling in to make sure that they’re the type of person they can be sharing information with,” he said.

After Hurricane Harvey struck Texas in August, HHS Secretary Dr. Tom Price waived certain HIPAA penalties, which can range from $100 to $50,000 per violation. Providers would not be penalized for failing to giving out notices of privacy practices, for instance, nor would they be hit for not granting a patient the right to request privacy restrictions.

Meanwhile, other provisions of the HIPAA privacy rule were still in effect, including those that allow providers to disclose protected health information to patients’ families or others involved in their care. Other provisions allow providers to give out protected health information—including to law enforcement—if doing so would lessen a threat to those patients or to the public.

Given those rules, “when you have a shooting, the department has taken the position that a waiver isn’t necessary,” said Marcy Wilder, a privacy and cybersecurity lawyer with Hogan and Lovells, noting that no penalties were waived after the 2016 mass shooting that killed 49 people and injured 58 at Orlando’s Pulse nightclub. “The department wants to be careful here, because if you issue a waiver, that becomes a suggestion that without a waiver, these types of disclosures aren’t permitted,” she added.

Swearingen warns that Las Vegas hospitals therefore need to be cautious. “The hospital, I would hope, in this circumstance is going to be fairly guarded.”

Read More: http://snip.ly/8u7xj#http://www.modernhealthcare.com/article/20171002/NEWS/171009996/las-vegas-hospitals-must-follow-regular-hipaa-privacy-rule