To understand AI advancements in health care, there are two storylines we must follow

If ever there were an industry that could reap the benefits of AI, it is healthcare. The adoption of this technology to actually make medicine better is obvious. However, with this adoption comes a slew of ethical issues.

Let’s start with some numbers: In 2018, the US spent $3.65 trillion on healthcare. That works out to $11,121 per capita, a 4.4% increase over 2017. In addition:

• Spending on hospitals, doctors, and other clinic services was $2.16 trillion, holding steady at 59% of total health care spending.
• The spending category that experienced the most substantial year-over-year increase was the general cost of administering health insurance, which rose 7.7% in 2018.
• Spending on prescription drugs purchased in retail pharmacies went up 3.3% in 2018, higher than the 0.4% rate in 2017.
• A majority of the more significant spending totals were due to higher overall prices, while the “use and intensity” of health care services played a smaller role.

The per capita spend in western economies, other than Switzerland, which was about 80%, was 50% or less. The worse news is that the US has slipped to 36th in the world in quality of healthcare. (The above data is from Centers for Medicare & Medicaid Services and CIA World FactBook.)

Another lesser-known statistic is the magnitude of iatrogenic disease. From Wikipedia: an iatrogenic disorder occurs when the deleterious effects of the therapeutic or diagnostic regimen causes pathology independent of the condition for which the regimen is advised.

In other words, they are harmed by medical practice. According to a Johns Hopkins study, 251,454 deaths stemmed from a medical error – making it the third leading cause of death in the US, just behind cancer and heart disease.

All industries are facing the problem of which areas to apply AI. In an article in Healthcare IT News, some advice for the healthcare industry was: while AI may have the potential to discover new treatment methods, the report finds strongly entrenched ‘ways of working’ in the healthcare industry that are resistant to change. The authors warn that ‘simply adding AI applications to a fragmented system will not create sustainable change.’ Good advice for any industry.

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Robotic surgeons set to spark ‘revolution in healthcare’

Specialists working on patients while controlling automated arms could turn into another standard in medical clinics.

The help of robots in careful rooms are anticipated to change the manner in which activities are performed by enabling medical procedures to be done as keyhole techniques.

As the utilization of mechanical medical procedure turns out to be progressively well known, an expanding number of surgeons are being prepared in how to utilize them. They enable specialists to perform complex strategies utilizing an insignificantly obtrusive methodology.

Expert colorectal specialist Jonathan Morton is among a bunch of doctors who have evaluated the hardware.

He said: “It’s quite exciting to see robotic techniques rolled out – from an ergonomic point of view, the system is set up better so that the stresses on the body are less, reducing injury rates for surgeons.

“It’s not actually the robot doing the surgery – it’s the surgeon with the experience and the knowledge telling the robot what to do, effectively it’s the same as keyhole surgery with robotics.”

The robots have four flexible joints like a human arm and are controlled by a surgeon using a joystick and a 3D screen. The technology is capable of carrying out a wide range of tasks.

CMR Surgical, the company behind the robot, claims the technology will revolutionise healthcare.

The firm’s chief medical officer, Mark Slack, said: “The vision we have is that we have built a system to enable many more patients to get MAS (minimal access surgery) and all the benefits that that brings for them – like reduced complications, reduced pain – and the aim is to put these in as many hospitals as we can.”

The NHS is developing a £50m framework for robotic surgical equipment, soon to be rolled out across the country.

So does the future of surgical procedures rest in non-human hands?

Richard Kerr, of The Royal College of Surgeons (RCS), believes it’s poised to change the nature of surgery forever.

“The robots are not going to be taking over what surgeons do. They will become an integral part of the tools surgeon use to carryout operations on their patients,” he said.

“Maybe in the long-distance future some aspects of surgery may potentially be delivered by robots.”

The RCS says a majority of NHS trusts have guidelines which surgeons are expected to follow when using robotics

More at https://news.sky.com/story/robotic-surgeons-set-to-spark-revolution-in-healthcare-11810158

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

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

The role of packaging in food safety and security

The role of packaging in food safety and security is paramount. Perhaps no other factor plays the role of packaging when it comes to ensuring food safety and security. The role of packaging in food safety and security can be understood at its barest from the fact that packaging saves the product from rotting, contamination and a host of other undesirable changes.

Food being a highly decomposable item; it is prone to many effects resulting from pests, microorganisms and other contaminants. It is here that the role of packaging in food safety and security comes into play. Proper packaging not only protects food from the influence of any of these; it also helps the food to retain its moisture, shape, substance and other important characteristics. The most important attribute of the food that packaging in food safety and security plays is in helping to preserve the nutritive value of the food item.

The role of packaging in food safety and security and its importance to the world
Food is the most essential need for all animals, including man. In the developed world, there is such a surplus of food that much of its gets wasted. The role of packaging in food safety and security is in ensuring that this can be minimized to a great extent. If food is properly packaged, it is possible to extend its shelf life and have it consumed after a while, instead of altogether throwing it away.

On the other hand, the role of packaging in food safety and security is equally important in many other parts of the world, there is not enough food for millions of people. When food is packaged rightly, its use can be optimized. The developed world transports food in millions of tons to the developing world. The role of packaging in food safety and security is crucial in such operations, where the quality of the food can be retained.

The role of packaging in food safety and security in the globalized world
When food that is prepared in one part of the world gets consumed in another; the role of packaging in food safety and security acquires vital importance. This is what is happening in today’s globalized world. Food companies have their operations in almost any part of the globe that makes economic sense for them. This food is not necessarily fully consumed in the part of the world in which it is produced. Rather, it reaches out to different parts of the world. This globalized system works in the food industry just like the way it works in a garment or an automobile business.

Key points
Countries of the world follow many of these regulations and conventions in addition to the many of their own. The core concept behind these regulations is that food must be safe throughout the supply chain, from the proverbial “farm to fork”. Planners and thinkers around the world work in tandem to understand the food problems the world is facing and prioritize their tasks towards ensuring that a good part of the inequities get minimized, if not outright eliminated. In ensuring this, the role of packaging in food safety and security is primary.

 

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How to choose a supply chain management solution

Any business that opts for a supply chain management solution has to have clarity on how to choose a supply chain management solution. This is because the supply chain management solution is expected to carry out a number of very important functions. Choosing the wrong or inappropriate one can backfire on the business and derail and impede, rather than ease its work.

Businesses have to take a few important factors into consideration when they have to choose a supply chain management solution. For the supply chain management solution to perform its function of facilitating the supply chain for the business, it needs to perform its functions smoothly without causing hiccups to the business. This is where the decision-making ability of the business owner comes into picture.

So, what factors need to be taken into consideration when a business has to choose a supply chain management solution? Try considering these:

1. Choose by industryThis is obviously a no brainer, but it is an important first consideration nevertheless in choosing a supply chain management solution. Many supply chain management solution providers sell the idea that these are one-size-fits-all solutions that work across a number of industries since the core functions are essentially the same.

This may be true to an extent, but while a number of functionalities are common across a few industries; it is important to get down to the one that is built for your business. A supply chain management solution that works best for retail, for example, may not be as effective for an automobile store. Getting down to the details and dissecting the functionality that the supply chain management solution performs for your particular industry is an important first step in choosing a supply chain management solution.

2. Define your needThis is the next important consideration when choosing a supply chain management solution. A number of supply chain management solutions are available in the market. Choose the one that suits your need the best. In order to do this, the business has to define its need to the fullest extent. It could take a few factors such as this into consideration:

3. Understand the integration function of the supply chain management solutionIntegration is, well, the very soul of a supply chain management solution. The business should have clarity on what functions need to be integrated into the supply chain management solution. The reason for which the integration function is built into a supply chain management solution is to facilitate synchronization of the whole chain. This makes it one of the core factors that determined how to choose a supply chain management solution.

4. Insist on the visibility featureVisibility is a great means for the business to have control over its sales, inventory, logistics, and a host of other functions. The supply chain management solution has to offer visibility on all these functions.

5. Customer relationship management (CRM)A supply chain management solution is incomplete if it does not come equipped with a strong CRM feature. The CRM is the determinant in helping to establish a good relationship with the customer. The CRM feature should enable the business to completely understand the nature of the orders and their status, plus, more importantly, help in customer query responses and other important customer-related features.

 

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Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about by globalization, namely outsourcing, has further increased the need for global supply chain regulatory compliance.

Global supply chain regulatory compliance has now become something on which organizations cannot compromise. Any shipment of any item that reaches foreign shores can get rejected if it has not met global supply chain regulatory compliance. Such a consignment could even get labeled as counterfeit. This explains the importance and need for global supply chain regulatory compliance. Being in global supply chain regulatory compliance means adhering to even the local laws of the foreign country into which goods and products are exported.

Governments have become more stringent 

As a result of these trade and technological developments; governments all around the world without exception are jumping on the bandwagon to formulate laws that apply to the supply chain industry. For most governments, global supply chain regulatory compliance is a must. They are becoming extremely strict in enforcing these laws and are handing out severe punishments to businesses and organizations that are lax in enforcing global supply chain regulatory compliance. Most countries are legislating laws regarding global supply chains almost exclusively, in a way that other political acts are framed. This has pushed the need for global supply chain regulatory compliance further.

Other related developmentsAs technologies advance in the global supply chain, many developments in auxiliary and supplementary fields have hastened global the push for supply chain regulatory compliance requirements. For example, heavy paperwork, which used to be hallmark of most merchandising businesses, has made way for automation. Global supply chain regulatory compliance has to take factors such as these into consideration.

Other developments in allied areas such as intellectual property rights have gone on to strengthen the role of global supply chain regulatory compliance. As countries demand greater protection for their intellectual property products, they use global supply chain regulatory compliance as an instrument to enforce these, when these products concern exports.

In addition, there could also be other critically important issues in global supply chain regulatory compliance that may not be related to any of these, but can play a decisive role in disrupting global businesses. Think of natural disasters such as the Fukushima earthquake or the many natural disruptions such as hurricanes in South and North America. These could throw businesses out of gear. Global supply chain regulatory compliance is a kind of insulation against the uncertainties caused by events such as these.

In other words, global supply chain regulatory compliance should leave no stone unturned. There is no scope for compromise of any kind in implementing global supply chain regulatory compliance provisions.

Items that go into global supply chain regulatory complianceMeeting global supply chain regulatory compliance requirements means having to take care of a number of ingredients. Some of these are:

Upcoming crucial global supply chain regulatory compliance regulation in the USSeveral legislations aimed at bringing about global supply chain regulatory compliance are in place. However, at this point of time, a really crucial global supply chain compliance regulation that could play a major role in the US in the coming years is the Automated Commercial Environment (ACE).

In a nutshell, this U.S. Customs and Border Protection (CBP)-mandated regulation aims to bring in place a single portal which will make information on imported goods flow electronically from the businesses themselves right to the respective departments or agencies that require and handle them. The ACE is aimed at making import and export related work paperless, while also seeking to become a major facilitator of trade.

 

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Why Trade Compliance and Logistics Must Work Together

Trade compliance and logistics must work together for a number of important reasons. While on the surface, trade compliance for logistics may seem burdensome for many organizations, the benefits of getting their trade compliance and logistics to work together are multifold and far outweigh the short term effort that goes into it, and that of noncompliance.

Undoubtedly, the most important reason for which trade compliance and logistics must work together is that they ensure that there is compliance with the laws of the countries into which the goods travel. It is a lot easier and a lot uncomplicated to have goods moving within national boundaries, where one can expect familiarity with the rules and the operating environment. In the case of global trade, the story is different.

Need to grapple with multiple laws

There is great diversity and complexity of laws that govern trade compliance and logistics. They are now more integrated than at any point of time before because of the advent of new technologies. This brings in a motley mix of the elements of global business, such as currencies, laws, locations, people and so on. Businesses that have a stake in the global trade have to deal with these varieties and diffuse elements. One of the surest ways of ensuring that these are managed rightly is by getting trade compliance and logistics to work together.

Since there is a multitude of international laws that need to be complied with at many stages of the global supply chain; trade compliance and logistics must work together. This is the only sure way of ensuring that the company’s goods and products meet the required international trade guidelines and reach their destination safely.

A way out of the complexity

For many in the business of exports, complying with the global supply chain may seem complex. However, knowledge of the laws of respective countries and building a sound logistics and supply chain infrastructure will go a long way in mitigating the problems associated with these. This is why trade compliance and logistics must work together.

Imagine a consignment of textiles originating somewhere in the Middle East headed for North America. This consignment has to pass through a few countries, at each of which it has to be sure it meets the compliance requirements. Finally, even when it reaches its destination, it must ensure that the laws of that country are complied with.

Increased efficiency and enhanced reputation 

Another important reason for which trade compliance and logistics must work together is that there are substantial long term gains to be had by doing so. Supply chains that have come about as a result of trade compliance and logistics working together become more reliable and efficient. All these mean reduced costs in the long run, increased customer satisfaction, and enhanced reputation in the business.

Elaborating on the point above, it is also equally true that trade compliance and logistics must work together to pump up nations’ economic growth. A country that ensures that trade and logistics are in accordance with internationally legislated laws on the subject are more likely to be trusted by global businesses. Countries in which trade compliance and logistics work together and result in sound business infrastructure are naturally more preferred by businesses as transit routes or destinations for their products. This brings in substantial revenues to the countries.

 

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200+ followers. WOWWWWWW…

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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Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices

Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality.

The FDA describes a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”.

FDA’s complaint handling guidelines are critical for ensuring that an organization maintains safety with regard to the medical devices they manufacture. Errors in medical devices can result in complaints, and improper handling of complaints can lead to problems for the patient, ranging from injury to fatality.

It is to prevent these problems that the FDA has issued complaint handling guidelines. FDA’s thinking is based on the reasoning that a complaint may be an indicator of serious safety, but implementing effective complaint handling guidelines can greatly mollify the gravity of the issue. It is also the first step to initiating new product development, which in turn has the potential to greatly reduce risks associated with noncompliance.

Regulations in place

Provisions relating to effective complaint handling provisions are contained in FDA 21 CFR Part 820 and GxP regulations.

Firstly, these complaint handling guidelines require medical device manufacturers to maintain complaint files. Manufacturers have to make this the first step towards establishing a sustainable complaint management system.

Secondly, Section 198 of Part 820 warrants the following:

Thirdly, FDA 21 CFR Part 820 requires the manufacturer to establish and maintain procedures for the receipt, review, and evaluation of complaints.

What should records of investigation contain?

Records of investigation should contain the following:

• Identifiers related to the device and reported event
• If Medical Device Reporting is made, it should investigate the following:
  • Whether there were any specifications the device failed to meet
  • Whether it was for treatment or for diagnosis that the device was being used
  • In what way the device was related to the reported event, if applicable

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