Risk management being a mandatory component of almost any activity in the medical device industry.
Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.
Risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.
The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.
The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.
Following personnel will benefit from the course:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Project managers
- Design engineers
- Software engineers
- Process owners
- Quality engineers
- Quality auditors
- Medical affairs
- Legal Professionals
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For many years before the advent of automation and computerization ,healthcare processes, such as billing, admissions, and many elements of care were carried out manually. Although it was a capable method to quite an extent, it relied on the use of the manual process or the human method. This was always prone to mistakes and errors, because humans are prone to committing errors that can creep in even with the best of intentions, as a result of which the healthcare industry ended up losing billions of dollars that could otherwise have gone into meaningful forms of investment.
A result of technological developments
This is why Business Process Management (BPM) in Healthcare came into existence with the advent of and as a byproduct of automation. Business process management in healthcare is being considered a major step in helping healthcare settings reduce costs and inefficiencies. When a unit implements business process management in healthcare; there is an automatic reduction in errors and inefficiencies. Let us see how:
Impetus from the higher authorities
There is now a general tendency and effort to push for automation in the healthcare industry. Even the American Congress has been aggressively pushing for reforms in the healthcare industry, a prime feature of which is fostering business process management in healthcare. Overall, BPM in healthcare is a means for improving efficiencies throughout the healthcare chain and bringing about greater integration and accountability through automation.
Core areas of business process management in healthcare
Business process management in healthcare is useful across the healthcare process chain, but is particularly so in at least there important areas:
This is one of the prime areas in which business process management in healthcare can make a huge difference. With complete automation of this critical area of business, healthcare units ensure that there is total coordination and traceability of the billing process.
Software:Apart from billing, another area in which business process management in healthcare helps tremendously is software. Software applications can bring about a huge change in the speed of operations. This area of BPM in healthcare reduces the need for human intervention at various stages of the business process.
Big data:Another of the areas in which business process management in healthcare holds huge promise is big data. Big data can help to make sense of various data used in healthcare administration and disease management across entire geographies. This makes the role of business process management in healthcare all the more meaningful and exciting.
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With the social media having moved beyond being a platform for sharing personal information; its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare.
Whatever the identifiable or unidentifiable reasons for the convergence of social media in healthcare; the fact is that social media in healthcare is a major phenomenon that is here to stay.
Social media in healthcare is being analyzed for potentially huge business opportunity, and it is being taken up for serious discussion in legal circles, with the American Congress and many other legislative bodies around the world thinking of taking serious steps for regulating it.
The most fundamental aspect of social media in healthcare is that its growth has been helped by the core feature it brings: its ease of adaption in this sector. Healthcare information, as we all know, is very vital, and speed is of great importance. This is why social media in healthcare has come to be one of the most talked about scenarios in the healthcare today, propped in no less measure by the gigantic size of the American healthcare economy.
The advantages social media brings into healthcare
As just seen, the social media in healthcare facilitate great use because they help transmit information at a pace that was difficult to imagine till recently. With the development of the electronic health records (EHR) in the US, technology has made possible the customization of health records. A platform like the social media can help accelerate this pace enormously. It can also help practitioners and other stakeholders of healthcare information, such as Business Associates and Covered Entities and a host of related ones gather information and transmit it and process it at lightning speed.
The enormous benefits that the social media bring into healthcare notwithstanding; there is room for serious concern.
Like all other technology-driven tools, the social media in healthcare comes with an inherent risk: the laxity of records. Loose or nil security or healthcare records are a serious cause for concern. The recent breaches in health data have cost many healthcare organizations in the US millions of dollars.
The social media in healthcare give an opportunity for marketers to pitch their products or services, but they also open up lots of opportunity for the unscrupulous among these to exploit and manipulate this information. This is akin to the potential drawbacks credit cards and other such facilities bring. The social media in healthcare is a tool that is open to a high degree of vulnerability to breach. This is all the more true of new technologies, such as the cloud, which the social media in healthcare have embraced with open arms.
So, while the social media in healthcare is a force to reckon with, it is not something that is totally free of drawbacks. Till regulatory action frees the sector of these, the social media in healthcare will continue to grow, albeit with its concerns.
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