Interclean Shanghai

Critical Medicine Dearth – Measures Taken By EU Commission

The European Commission has gone on to take steps so as to tackle the issue of critical medicine shortages. These actions include putting up a unified strategy when it comes to stockpiling drugs and establishing a shortage alert system throughout the European Union. The aim is to prevent a recurrence of the situation that one went through in 2022.

According to a press release from the Commission dated October 24, a Communication went on to be published with the aim of preventing and mitigating critical medicine shortages at the EU level. The Communication is intended to address the issue not just for this winter but also for future winters.

During one of the recent press briefings, Stella Kyriakides, Health Commissioner, expressed her commitment to implementing collective actions when it came to the EU level. These actions aim to enhance the well-being of citizens for the medium and long term and not just the upcoming winter.

Kyriakides went on to express her disbelief at the current situation in Europe in 2023. She stressed that it is unacceptable for patients to be deprived of the necessary medications, particularly with regard to the efforts being made to set up a health union.

It is well to be noted that during last winter, many Europeans faced a harsh reality that was previously unthinkable. They had to deal with a surge of respiratory viruses along with ongoing COVID-19 infections. Additionally, there were challenges such as limited manufacturing capacity, a lack of raw materials, distribution issues, labour delays, and even natural disasters.

Kyriakides stated that medicine shortages cannot be resolved right away due to their long-standing and multifactorial causes.

In order to avoid a similar situation, the Commission has now put forth a proposal in terms of an operational response. This is needed because the actions outlined in the drug strategy cannot be implemented at the moment, as the dossier is still being reviewed by the Council and Parliament.

What does the communication consist of?

The proposed response from the Commission incorporates various aspects of pharmaceutical reform. These include asking companies to provide earlier notification of shortages, implementing shortage mitigation strategies for all medicines, and enhancing the sharing of information when it comes to shortages at the EU level.

The actions include the implementation of a European Voluntary Solidarity Mechanism for medicines, the establishment of a comprehensive list of critical medicines, the implementation of regulatory flexibilities, as well as the provision of EU guidance on purchasing.

The European Voluntary Solidarity Mechanism for Medicines has been established to promptly assist countries that experience shortages by allowing them to request support from countries that have an adequate supply.

Efforts to establish a comprehensive list of critical medicines, consisting of 100 to 350 essential medications, will be expedited. The aim is to offer an initial list by the end of this year. By April 2024, one will have analysed the supply chains of specific drugs and identified measures so as to address any shortages.

The Commission will develop a common strategic approach to medicines accumulating in the first half of 2024. This approach aims to avoid and minimise shortages in collaboration with member states.

Furthermore, the Commission plans to establish a Critical Medicines Alliance, which is expected to be working by early 2024. This initiative is referred to as an industrial policy pillar of the European Health Union.

Kyriakides stated that this alliance is an innovative approach for public authorities in the EU to collaborate with the industry. The aim is to provide effective solutions that ensure an uninterrupted supply of medicines.

The Commissioner has announced that the Alliance will have access to a range of actions. These measures will involve public procurement, strategic partnerships to broaden global supply chains, boosting Europe’s production capacity for medicines and ingredients, and coordinating EU and national funding.

Lastly, the Commission will set up a network of international partners with the aim of addressing supply chain resilience. Kyriakides emphasised the importance of global collaboration in the quest to achieve greater variety in supply chains.

The pressing issue at hand is being addressed by the health minister of Spain, Jose Manuel Minones, who currently chairs the EU Council presidency. He expressed his approval of the Commission’s announcement during a meeting of the Parliament’s health and environment committee, which took place on October 23. There is a need to examine the supply chain for medicines and take proactive measures to ensure its robustness and efficiency, and they also aim to enhance the security of supply and assess the overall state of medicine availability beyond times of crisis.

Before the announcement by the Commission, Emer Cooke, the chief of the European Medicines Agency, presented to Parliament the actions being taken by the agency. As per her, they have successfully obtained the demand data from the member states as well as the supply information from the manufacturer. Furthermore, this has enabled to effectively identify areas where shortages or shortfalls may occur, allowing to take proactive measures in a timely manner. EMA has developed a regulatory toolkit to effectively manage critical shortages by closely tracking contact with manufacturers. Cooke pointed out the importance of exploring alternative suppliers and allowing certain labelling flexibility. The debate on shortages continues to be a topic of discussion.

Italian DPA Adopts GDPR For AI-Controlled National Health

Making use of artificial intelligence systems across the framework of the pharmaceutical and healthcare industries is indeed going through a rapid growth. It is anticipated that the execution when it comes to these systems will yield substantial advantages for individuals as well as society. However, it is important to take into account the significant opportunities that happen to be associated with the use of AI along with the relevant risks, majorly in sensitive sectors such as pharma and healthcare.

Because of this reason, the Italian Data Protection Authority- IDPA has released a document identified as the Decalogue for the launch of national health services by way of artificial intelligence systems. The purpose of this document is to emphasise the key privacy concerns that must be taken into account when utilising AI systems in the context of national healthcare services.

According to the proposed EU AI Act, the Decalogue emphasises which AI systems affecting health, such as those that affect the right to receive treatment, healthcare service usage, medical care, as well as patient selection systems for emergency care, are all categorised as high-risk systems. The Decalogue offers the main issues and responsibilities with regards to privacy that arise when making use of AI systems in the healthcare industry.

While the Decalogue fails to include new ideas or principles, it goes on to provide clear guidance on the steps that healthcare sector stakeholders ought to take to ensure the correct application of AI, which is in sync with the GDPR. Furthermore, the principles outlined in the Decalogue are applicable to all high-risk AI systems, irrespective of their application across the healthcare sector.

Let’s look into the principles that happen to be laid out by the IDPA.

  1. Analysing the legal template

The IDPA points out that Article 9(2)(g) of the GDPR happens to be an appropriate legal basis for utilising AI systems when it comes to national healthcare services. Under Italian laws or regulations, the handling of personal data must be required for reasons of significant public interest. It is necessary to indicate the groups of data to be analysed, the kind of functionality that can be performed, the reasons for significant public interest, and the appropriate steps needed to safeguard the rights and freedoms when it comes to the data subjects.

  1. The fundamentals of accountability and privacy by layout and standard settings

The IDPA emphasises the importance that accountability, privacy by design, and privacy by default principles possess. The utilisation when it comes to AI systems within the national healthcare services gamut should align with these norms. It is crucial for stakeholders to ensure that data processing corresponds to the public interests that are being pursued. Additionally, they should incorporate safeguards for data beginning with the design phase and across the entire lifecycle of generative AI tech.

  1. Roles of Privacy

The ideas of controller and processor are functional concepts that aim to distribute responsibilities upon the roles of the actual stakeholders. Privacy roles should be given based on facts rather than otherwise. In order to ensure compliance with GDPR while making use of AI systems, it is crucial to correctly delegate privacy roles to the stakeholders that happen to be relevant. This involves allocating rights, duties, as well as responsibilities accordingly.

When it comes to national healthcare services, it is essential for stakeholders to clearly define their respective roles in terms of privacy. This is especially crucial in relation to the national AI system in the healthcare sector, which will be accessible to various entities for different reasons. Hence, it is essential to have an overall understanding of the data governance framework.

  1. The fundamentals of knowability, non-exclusivity, and algorithmic non-discrimination

These tenets go on to represent the three pillars that guide the use of AI systems in carrying out important tasks that happen to serve the public interest:

  • The principle of knowability is all about informing the data subject about the existence of a decision-making procedure that is based on automated operations as well as on the logic behind these operations.
  • The principle of non-exclusivity should involve human intervention to ensure that there is control over automatic decisions.
  • The principle of algorithmic non-discrimination suggests that data controllers ought to take responsibility for appropriate measures to minimise opacity and errors in order to prevent any potential discrimination that may arise from processing inaccurate health data or making use of incorrect statistical and mathematical techniques.
  1. Data Protection Impact Assessment- DPIA 

According to the IDPA, conducting a Data Protection Impact Assessment happens to be essential for the lawful use of AI systems in national healthcare services as it involves the systematic and extensive processing of sensitive data pertaining to individuals who happen to be vulnerable.

The DPIA should be conducted at the national level to ensure a thorough evaluation when it comes to all factors that could impact the processing of personal data, particularly the risks that come associated with a database containing health data for the entire set of population.

The IDPA’s statement is applicable not only to national healthcare services but also to any AI system that involves the organised as well as large-scale processing of patients’ health data.

  1. Data quality

Under Article 5(1)(d) of the GDPR, organisations are obligated to guarantee the relevance and accuracy of personal data. It is essential for healthcare operators to comply with this rule in order to protect the interests of patients. Processing inaccurate data can have serious repercussions for the safety and health of patients.

Therefore, it is necessary for the stakeholders to take suitable steps in order to ensure data accuracy and effectively deal with the risks associated with:

  • Relying on systems without rigorous scientific validation,
  • lacking control over processed data, and
  • making decisions based on inappropriate assumptions.
  1. Data integrity and secrecy

According to Article 5(1)(f) of the GDPR, organisations are required to process personal data in a way that ensures sufficient safety of the data, in line with the confidentiality and integrity concept. The IDPA emphasises that when using deterministic as well as stochastic analysis models based on machine learning techniques, there are substantial risks related to potential biases. These biases can lead to adverse consequences for the individuals whose data is being analysed.

Due to this reason, the IDPA places great emphasis on organisations providing detailed indications regarding:

The AI system uses algorithmic logic to train itself and generate its output.

  • The checks carried out to prevent biases
  • The corrective measures taken to address and rectify these biases; and
  • The risk associated with both deterministic and stochastic analyses
  1. Fairness as well as openness 

Organisations in the healthcare sector that utilise AI will need to implement the following measures to guarantee compliance with the principles of fairness and transparency, in addition to the commonly required measures:

  • Explain the AI system’s logic and data processing;
  • Clarifying if AI-using healthcare professionals happen to be liable;
  • Highlighting AI’s diagnostic and therapeutic benefits;
  • Ensure healthcare practitioners intervene when utilising AI systems for treatment.
  1. Human monitoring

In order to mitigate the significant risks that come with using incorrect information to train the algorithm or relying on assumptions made by the system, it is essential for humans to play a central role in both the training phase and the process of making decisions.

  1. More details on data protection rules related to the preservation of dignity and personal identity

The IDPA concludes by emphasising the significance of employing ethics as the foundation for governing the use of AI. Ethics should play a crucial role in guiding organisations when selecting suppliers and business partners who adhere to the principles outlined in the Decalogue.

Compliance with data protection legislation will be essential to companies creating, disseminating, or employing AI in order to ensure the success of their business. These organisations should be able to show their trustworthiness in terms of data protection. Putting in a privacy-centric strategy can be crucial for guaranteeing business success.

What are the 4Ps of pharmaceutical marketing?

Pharmaceutical marketing is the activity of promoting drugs and medical devices by private and public organizations to doctors, clinicians, and consumers. In 2022, approximately $603 billion dollars were spent on drugs in the United States, making marketing a top priority for major players in the pharmaceutical industry. Given this huge expenditure, most companies realize how important marketing is to gain pharma market access. In this article, we will look at the 4Ps concept and its application in pharmaceutical marketing.

Pharmaceutical marketing

Pharmaceutical marketing is the process of promoting prescription drugs and other medical products to both medical professionals (doctors, pharmacists and nurses), patients and consumers. Its primary goal is to increase product awareness, attract potential customers, and stimulate sales.

The pharmaceutical industry is governed by stringent government regulations aimed at safeguarding patients from inaccurate or deceptive assertions. These regulations exhibit variations across different nations and typically encompass areas such as:

  • product claims must be truthful and supported by scientific evidence;
  • many countries have restrictions on what types of statements can be made in product advertising;
  • pharmaceutical companies are generally prohibited from giving gifts or payments to health professionals that could influence their prescribing decisions.

In addition to these regulatory challenges, pharmaceutical marketers also face a number of other challenges, including:

  • product complexity – pharmaceutical products are complex and often have serious side effects that marketers must report;
  • an oversaturated market;
  • the cost of developing and marketing new pharmaceutical products is rising rapidly, putting pressure on marketers to be more effective in their campaigns.

Success in the pharmaceutical industry hinges on the imperative of strategic marketing. An effectively crafted marketing strategy has the potential to assist companies in achieving the following objectives:

  • identify and target their target audience;
  • position their products;
  • increase brand awareness and trust in the company’s products.

By developing and implementing a strategic marketing plan, pharmaceutical companies can increase their chances of success in a highly competitive marketplace.

The 4Ps system in pharmaceutical marketing

Pharmaceutical marketing involves four key elements known as the 4Ps: product, price, distribution, and promotion. These four components work together to form a marketing strategy that helps pharmaceutical companies successfully introduce their products to the market.

Product

The Product aspect of the 4Ps framework considers the pharmaceutical product or service offered to the market. This aspect covers all the characteristics of the product including its physical properties, functional features and benefits to both patients and healthcare professionals.

There are many different types of pharmaceutical products, each with unique marketing characteristics. The most common types of pharmaceutical products include:

  • prescription drugs;
  • over-the-counter medications;
  • vaccines;
  • medical devices;
  • generics (copies of brand-name drugs).

oping a marketing strategy for a pharmaceutical product, it is important to consider the specific needs and expectations of the target audience. For example, when promoting prescription drugs among medical professionals, it is necessary to emphasize the clinical effectiveness and safety of the drug. And when presenting over-the-counter drugs to consumers, it is important to emphasize their benefits and ease of use.

Price

The element “Price” within the 4Ps framework refers to the value that customers are willing to pay for a product. Price plays a key role in the marketing strategy of pharmaceutical products as it influences both the level of demand and the profitability of the product.

Pharmaceutical companies can utilize a number of different pricing strategies. Common pricing strategies include:

  • cost-based pricing;
  • value-based pricing;
  • competition-based pricing.

When determining the price of a pharmaceutical product, companies must consider several factors including product development costs, the competitive environment, and the needs of both patients and healthcare providers.

The issue of affordabilits of serious importance in the pharmaceutical industry because many patients cannot afford to pay for the medications they need. Pharmaceutical companies are making efforts to address this problem by offering discounts and financial support programs to patients.

Place

The Place element of the 4Ps framework refers to the channels through which a pharmaceutical product is made available to customers. These channels include pharmacies, hospitals, and other health care facilities where the product can be purchased.

Distribution represents a critical aspect of pharmaceutical marketing because it ensures that patients and healthcare professionals have access to the products they need.

When choosing a distribution channel, pharmaceutical companies must consider a variety of factors, including product characteristics, target audience, and competitive environment. For example, drugs that require a prescription are most often distributed through wholesalers and pharmacies, while vaccines are often supplied through government agencies.

Promotion

The Promotion element of the 4Ps framework refers to the activities that pharmaceutical companies undertake to communicate the benefits of their products to target audiences. This includes various marketing methods such as advertising, public relations, sales promotion and direct marketing.

Pharmaceutical companies can utilize various advertising strategies. Some common advertising strategies include:

  • advertising in various media, including television, radio, print, and the Internet;
  • working with the media to create positive publicity for their products;
  • promotions;
  • direct marketing – pharmaceutical companies can contact patients and health care professionals directly through e-mail, direct mail and through sales representatives.

Pharmaceutical companies must adhere to strict rules and regulations that govern the promotion of their products, while also taking ethical considerations into account. For example, companies must avoid making claims about their products that may be misleading or lack scientific substantiation. This is important to ensure the safety and trust of patients and healthcare professionals.

Integrating the 4Ps into pharmaceutical marketing

The 4Ps system is a valuable tool for pharmaceutical marketers. A real-life example of how pharmaceutical companies successfully integrate the 4Ps is the case of AstraZeneca.

AstraZeneca is a global pharmaceutical company that specializes in the development, production and sale of a variety of prescription drugs and vaccines. The company’s marketing strategy focuses on informing healthcare professionals and patients about its products and services. In addition, AstraZeneca actively works to establish partnerships with key stakeholders such as government agencies and insurance companies.

AstraZeneca’s marketing mix is a combination of the 4Ps: product, price, place and promotion.

Product

AstraZeneca’s product portfolio includes a wide range of prescription drugs and vaccines, including those for the treatment of cancer, cardiovascular, respiratory and infectious diseases. The company also develops and markets biopharmaceuticals – drugs derived from living organisms.

Pricing

AstraZeneca’s pricing strategy is based on a number of factors, including the cost of developing and manufacturing a product, the competitive environment, and the needs of patients and payers. The company also offers patient support programs to help patients afford the drugs.

Location

AstraZeneca’s products are distributed through various channels, including wholesalers, pharmacies, and hospitals. The company also sells some of its products directly to patients.

Promotion

AstraZeneca promotes its products to healthcare professionals and patients through various channels, including advertising, public relations, sales promotion and direct marketing. The company also works with healthcare organizations to educate them about its products and services.

AstraZeneca’s marketing strategy is successful because it is well aligned – all four elements work together to achieve the company’s marketing goals.

This is just one example of how pharma companies can successfully integrate the 4Ps system to create effective marketing strategies. By carefully considering product, price, place and promotion of their products, pharmaceutical companies can reach their target audience and achieve their business goals.

Emerging trends in pharmaceutical marketing

The field of pharmaceutical marketing is constantly evolving, fueled by advances in technology and changes in the approach to patient care.

Digital marketing is playing an increasingly important role in pharmaceutical marketing. Pharmaceutical companies are utilizing digital channels to provide healthcare professionals and patients with information about their products and services. 

Digital marketing tactics include:

  • search engine optimization (SEO);
  • pay-per-click (PPC) advertising;
  • social media marketing;
  • content marketing.

Patient-centered approaches are also becoming increasingly important in pharmaceutical marketing. Pharmaceutical companies are shifting their focus from promoting products to engaging with patients. This means they are focusing on developing and marketing products and services that meet patient needs, as well as providing patients with information and support.

Data-driven strategies are also used to improve the effectiveness of pharmaceutical marketing campaigns. Pharmaceutical companies collect and analyze data from various sources such as patient surveys, sales data, and social media data. This data is used to better understand the needs of patients and healthcare providers and to develop more targeted and effective marketing campaigns.

Conclusion

This article has discussed the main aspects of the 4Ps of pharmaceutical marketing – product, price, distribution and promotion. It is important to note that a successful marketing strategy in the pharmaceutical industry requires not only the ability to promote products, but also high standards of ethics and responsibility, as pharmaceutical marketing has a huge responsibility for the health and well-being of patients.

Moreover, in the dynamic pharmaceutical industry, constant adaptation and innovation is encouraged. Striving to improve products and services, as well as finding new solutions to meet patient needs, should be at the center of marketing efforts. Only such companies will be able to remain competitive and contribute to the development of healthcare.

Almost Every Healthcare Use Case Can Have Generative AI

Generative AI as well as big language models, such as the ones that power ChatGPT, are already being made use of in various healthcare landscapes. Developers are now in a way diligently exploring innovative tools to save time as well as enhance their primary technologies. These developments are being utilised by providers throughout various fields, right from patient engagement to clinical decision assistance.

After internet-led phenomenon, the next major innovation on cards is gen AI. This revolutionary landscape can completely transform the way one works and lives.

It is well to be noted that gen AI models have been in existence for quite some time, but it is the broad acceptance of these models that will really propel these changes on a large scale.

The applicability when it comes to this technology is already obvious through industries domains like healthcare. Whether it is enhancing an entire experience of the patient through conversational appointment-setting procedures, enabling medical professionals to examine relevant information through summarizations, or even strengthening overall efficiency of the hospital care system, every one of these applications happens to have an important effect on how one perceives patients and healthcare in its entirety.

Although this still happens to be in the early stages and many details are yet to be revealed, such as determining use cases with a low rate of mistakes, establishing confidentiality of information, and sharing rules to ensure ethical models, the results do show a lot of promise.

It is not possible that it can be consistently used for every possible use case, and certainly not at this point in time.

Generative AI sees various challenges when it comes to mainstream applications

There is still a lack of clarity regarding where exactly to submit an application. Businesses are feeling a sense of urgency to adopt gen AI, but this rush is causing them to choose use cases that do not provide significant advantages.

The majority of these models are experiencing hallucinations. Immense work is needed to guarantee that they are in a balanced state to support mandatory business operations. Plenty of companies may not be willing to proceed with a slower rollout in order to address these problems.

It is well to be noted that the present models come with a limited line of sight to the ROI. They happen to be expensive to use, and putting them to use is costly due to qualified employees’ shortage. Many companies are finding it difficult to clearly justify a significant initial investment in light of the long-term ROI. Mainstream adoption is going to be limited until economies of scale are taken care of, as only organisations with enough budget allocations will have the access.

Vendor Onboarding Process

These systems should be designed to thoroughly examine vendors’ compliance, safety, and governance procedures. By doing so, one can ensure that all necessary checks are conducted to assess the suitability of vendors. Accommodating all the nuances that come with AI technologies often necessitates a rewrite of internal guidelines.

A zero-trust policy is the need of the hour. There happens to be a need for a more robust compliance audits regarding the sharing of data when it comes to IT providers. It is significant to ensure that there is clear visibility into how this data gets shared and how it is being processed internally.

Investing in experts is pivotal. The landscape is constantly evolving, and everyone involved is constantly learning. In order to ensure the achievement of these launches, it is crucial to invest in internal skilled manpower and establish partnerships with industry collaborators who can go on to assist in evaluating and implementing the processes involved with these vendors.

Generative AI in healthcare, five years down the line

The rapid pace of technological advancements and the constant emergence of new applications on a daily basis, means that the timeframe that is 5-years can be perceived as a substantially long horizon. The initial rush and enthusiasm after 5 years would have lessened. Revamped business procedures would undoubtedly become widespread with the broad embrace of gen AI. Varied emerging solution offerings and technology players will dominate the market in highly specialised areas.

There should be a comprehensive revamp of compliance and regulatory guidelines to effectively monitor individuals engaging in illegal activities while also ensuring the protection of individual rights.

One of the most significant developments in the future is the increasing focus on preventative healthcare. This shift will involve continually tracking individuals’ well-being, ultimately leading to improved life expectancy for everyone.

The objective of the new publication is to offer a clear outline of fundamental values that governments as well as legal authorities can adhere to, which will go on to assist them in creating new policies or even modifying existing guidelines on AI at the national and even regional levels.

AI In Healthcare Gamut – WHO Considers Adding Regulations

World Health Organisation has recently gone on to release a novel document that goes on to highlight the key regulatory considerations when it comes to the usage of AI in the gamut of healthcare. The report puts forth the value of making sure the security and efficient operation of AI systems.

WHO acknowledges the probable benefits when it comes to AI in enhancing health outcomes. However, it also brings about concerns that AI systems often get executed in a hasty way without an in-depth understanding when it comes to performance.

Therefore, this has the capacity to be either beneficial or harmful to the end users, which include healthcare professionals as well as patients.

Dr. Tedros Adhanom Ghebreyesus, Director-General of the WHO, states that AI happens to have tremendous potential in enhancing healthcare. However, AI also presents significant challenges ranging from illegal data accumulation, dangers to cybersecurity, to ability to amplify biases or even spread misinformation. The purpose of this novel guidance is to help nations in successfully governing AI, and also let them take advantage of its potential in areas such as cancer treatment and also tuberculosis detection while also reducing the associated dangers that come along.

The publication goes on to identify six key areas for regulating AI in the field of healthcare:

  • Transparency and documentation: It is extremely pivotal to extensively document the whole product lifecycle and at the same time also keep a track of development processes.
  • Risk management: It is significant to deal with various problems such as intended use, continuous learning, human interventions as well as training models, and cybersecurity threats in a broad manner and make these models as much seamless as possible.
  • Validating data as well as being unambiguous about the usage of AI helps ensure safety as well as facilitate regulation.
  • Data quality:  Carefully evaluating systems pre-release is mandatory to guaranteeing systems do not cause surge in biases as well as errors.
  • Address the challenges put forth by significant and intricate regulations by placing a robust emphasis on comprehending the extent of jurisdiction as well as the requirements for consent. One such example is the General Data Protection Regulation- GDPR in Europe.

Partnership when it comes to regulators, patients, healthcare providers, industry representatives, as well as government partners is very significant. This can help ensure that products and services remain in line with regulations across their entire lifespan.

The ultimate aim of the new publication is to also offer a clear outline of the essential principles that governments as well as regulatory authorities can adhere to. This will help them in developing new guidelines and also modifying current ones on AI when it comes to national or regional levels.

Health Agencies Release 5 Machine Learning-Led Device Norms

Health Agencies Release 5 Machine Learning-Led Device Norms

The MHRA, FDA, as well as Health Canada have jointly gone on to publish five guiding principles for machine learning-enabled medical device- MLMD manufacturers so as to develop predetermined change control plans- PCCPs.

The idea behind these guiding principles is to assist manufacturers of MLMDs by decreasing the regulatory requirements for reconsideration in case of specific modifications or improvements to their respective devices.

Building upon the 10 guiding principles for good machine learning practice, the 5 guiding principles for manufacturers of MLMD state that a properly constructed and carefully planned approach must be:

  1. Bounded and focused: Describing the particular modifications that manufacturers intend to make.
  2. Risk-based: The intent, design, and execution of a PCCP are guided by an approach based on risk that follows the tenets of risk management.
  3. Evidence-based: Demonstrating that the benefits of using it outweigh any potential risks throughout its entire lifecycle.
  4. Transparency: Ensure that all stakeholders, including patients and healthcare professionals, are provided with precise and pertinent information, as well as comprehensive plans for maintaining transparency.
  5. Total Product Lifecycle Perspective: Enhancing the Quality and Integrity of a PCCP by continuously taking into account the viewpoints of all stakeholders to improve the overall quality and integrity of the product.

It is well to be noted that at present, in the UK, manufacturers must go on to inform their conformity assessment body whenever they make effective and significant alterations or updates to their medical devices. This communication is essential to ensure that the modifications that are made do not have any adverse impact on the operations or security of the device. As a consequence, the device could go on to face reassessment to verify its ongoing compliance.

Medical devices that make use of AI as well as machine learning may necessitate frequent updates, and this in turn can lead to certain long revision processes whenever a change is made. The implementation of this could enforce a substantial burden of regulation when it comes to both developers as well as assessors.

PCCPs helps manufacturers of medical devices with machine learning capabilities to showcase the changes that are proposed and also provide updates they are going to carry out. By doing so, they can show their bent to maintaining the safety as well as efficacy of their products without ever requiring any sort of regulatory intervention.

These guidelines outline the domains under which the MHRA, FDA, and Health Canada share similar standards for an acceptable PCCP, with an objective to minimise or eliminate the requirement for reassessment.

While these core values will go on to support the development of PCCP across the UK, US, as well as Canada, it is important to note that each regulator goes on to have its own specific national guidance that manufacturers have to adhere to. It is well worth noting that the guidance from the MHRA is expected to be published in 2024.

Dr. Paul Campbell, who happens to be the head of software and AI at MHRA, stated that AI and MLMDs have gone on to become more common, thereby requiring regulators to alter their procedures so as to facilitate improvements for patients while still prioritising safety. By working together with the FDA and Health Canada to create these core values, one can establish a clear understanding of shared expectations for a change control plan that’s effective. This collaboration will also contribute to easing the burden of regulation, which is often faced by manufacturers.

The collaboration among regulators about these guiding principles showcases the advantages of working with international partners. This partnership aids in the establishment of flexible regulatory processes that effectively promote innovative manufacturers and also patients across the world.

Philips & Quibim Partner To Boost Prostate Cancer Treatment

Prostate cancer goes on to have an important global impact. The American Cancer Society reports that almost every one in eight men across the US will face a prostate cancer diagnosis during their lifetime.1 Early detection when it comes to this disease mainly depends on a prostate-specific antigen, also known as a PSA screening blood test. This test can be especially useful in identifying cancer in the prostate at an early stage, especially when it comes to slow-growing tumours that remain localised within the prostate gland and fail to spread to other parts of the body. PSA screening tests, however, have little specificity when it relates to detecting serious types of cancer.

The result- this can lead to a high number of false positives as well as overdiagnoses. Therefore, patients end up going through painful biopsies that ultimately yield unfavourable outcomes, resulting in considerable anxiety as they eagerly await their biopsy results, which, by the way, is further made worse by an unnecessary burden on the pathology workload.

Although MR exams are typically more expensive and time-consuming as compared to PSA tests, current evidence suggests that MR scans can be beneficial as one of the assessing tools in case of guiding biopsy decisions. Additionally, MR exams can go on to serve as valuable diagnostic tools for treatment planning as well as personalised therapy, irrespective of the results from PSA testing.2 

MR exams have the ability to lead to cost savings as well as more precise diagnoses for patients by decreasing the number of unnecessary biopsies and allowing better-targeted therapy in cases of prostate cancer that require treatment. This can result in faster and more efficient healthcare outcomes.

It is well to be noted that Philips is currently making use of AI-powered technology, such as the MR SmartSpeed image reconstruction software. This software elevates clinical confidence by providing images with up to 65% higher resolution as well as exceptional quality.3

Philips and Quibim have partnered in order to develop an integrated solution that has in it Quibim’s QP-Prostate software4, which makes use of AI, to automate the division of the prostate gland in real-time magnetic resonance- MR images5. This solution aims at offering valuable quantitative insights while creating a uniform reporting system for MR prostate exams. By leveraging Philips’ AI-based MR imaging methods, the solution strives to equip clinicians with the required speed and precision to address the rising number of patients that look for MR exams. This will ultimately go on to enhance diagnostic trust, enable personalised treatment, and, at the same time, improve overall patient outcomes.

As per Ruud Zwerink, General Manager of MR at Philips, this collaboration seeks to enhance early detection of conditions such as cancer, boost accuracy in cases of first-time-right diagnoses, and at the same time optimise hospital operations in order to provide better care at reduced costs. The association with Quibim is going to eventually expand to include other types of cancer outside of prostate cancer. This is necessary because there is a growing need to enhance effectiveness and tackle staff shortages so as to provide high-quality oncology care to a larger set of patients. 

It is well to be noted that the collaboration between Philips and Quibim incorporates high-speed MR imaging coming from Philips with Quibim’s QP-Prostate software. The objective of this collaboration is to offer rapid and dependable diagnostic support across all stages of an integrated evaluation, treatment, as well as therapy assessment workflow. The upcoming form of the lesion detection algorithm will greatly enhance the potential of MRI as a game-changer in prostate cancer evaluation6, stated Angel Alberich-Bayarri, the CEO of Quibim. The purpose of this integrated approach, along with its workflow-enhancing features, is to deal with the challenges faced by radiology and oncology departments, such as staffing shortages, higher burnout rates, as well as financial limits. Patients will also experience significant benefits, such as lower complex and painful biopsy procedures7, as well as individualised treatment.

MRI has become an essential component of the prostate cancer diagnostic route due to its high sensitivity to aggressive tumors. One needs to enhance its sensitivity in order to prevent unneeded biopsy and improve its inter-reader replication so as to ensure accurate diagnoses can be made outside of expert centres, says Professor Oliver Rouviere, who leads the Department of Radiology at Hopital Edouard Herriot in Lyon. One of the major challenges for any AI software devoted to prostate MRI is to achieve both good specificity and an elevated degree of sensitivity. Their top priority is to ensure that they provide accurate and reliable diagnostic results, regardless of the imaging guidelines, magnetic field strengths, along with vendors involved.

References: 

  1. American Cancer Society, Key Statistics for Prostate Cancer
  2. Moore CM et al.: Prevalence of MRI lesions in men responding to a GP-led invitation for a prostate health check: a prospective cohort study; BMJ Oncology 2023
  3. Compared to Philips SENSE
  4. QP-Prostate is an FDA 510k cleared solution and a UKCA and CE mark (Class IIb) cleared solution under MDR.
  5. Jimenez-Pastor A et al.: Automated prostate multi-regional segmentation in magnetic resonance using fully convolutional neural networks. European Radiology 2023
  6. Automated lesion detection is pending regulatory clearance and is currently only available as a research-only solution.
  7. Elwenspoek MMC et al.: Comparison of Multiparametric Magnetic Resonance Imaging and Targeted Biopsy With Systematic Biopsy Alone for the Diagnosis of Prostate Cancer: A Systematic Review and Meta-analysis. JAMA Network Open 2019

Carestream Health Partners with EXAMION to Bring Innovative, Future-Focused Healthcare Imaging Solutions to Germany

Carestream India launches The DRX Compass, an Advanced digital radiology solution

Carestream Health announces a new future-focused partnership with EXAMION, a leading provider and servicer of medical imaging solutions in Germany for more than 30 years. The alliance strengthens Carestream’s commitment to providing healthcare organizations in Germany and throughout Europe with innovative diagnostic imaging solutions that help enhance both user and patient experiences while helping to improve clinical outcomes and streamline radiography workflows.

“Carestream offers a rich portfolio of diagnostic imaging solutions that can help German healthcare organizations of all sizes improve both patient care and operational efficiency,” said Jane Moverley, Director of International Sales at Carestream Health. “EXAMION is well-known and respected for its reliability and service in the medical imaging market. They are an ideal partner to help radiology departments throughout Germany leverage Carestream’s innovations to meet their most pressing challenges.”

X-ray Rooms for Facilities of All Sizes

EXAMION will bring the Carestream DRX-Compass and premium DRX-Evolution Plus medical imaging systems to the German market. Both solutions offer modular designs to fit individual spaces, workflows and budgets. Key features include:

  • Scalable designs that adapt quickly to changing provider needs
  • Modular designs that protect against obsolescence with the addition of new features and capabilities
  • Full functional benefits of a digital X-ray room
  • Optional AI-based Smart DR Workflow with Smart Positioning, Smart Technique, and Smart Collimation

We are pleased to expand our offerings to include the innovative digital X-ray imaging systems available from a well-respected company like Carestream Health,” said Bernd Schleicher, Chief Financial Officer of EXAMION. “Healthcare facilities throughout Germany can rely on EXAMION for comprehensive and competent service and support for all their Carestream medical imaging solutions.”

BitHealth and InterSystems Partnership Accelerates Digital Transformation of Healthcare in Indonesia

German hospitals to get €3 billion funding boost for digitalisation

BitHealth, a provider of digital health service solutions through innovative technology, announced its collaboration with InterSystems through the signing of a Memorandum of Understanding (MoU). This collaboration will create innovative digital solutions for the health sector in Indonesia to improve data management and integration, leading to better quality health services for the community. Representatives attending the event were Peter James Rampengan, Chief of Sales and Marketing, BitHealth and Luciano Brustia, Regional Managing Director, Asia Pacific, InterSystems.

Currently, the majority of hospitals in Indonesia face challenges in data integration and information management, which are often performed manually with the risk of human errors. Some hospitals also end up having various separate application systems required to run various aspects of hospital business operations which run independently and result in different languages and data standards. Data is held in multiple locations even within the same hospital environment. The effect of this lack of data integration is that reports and information become difficult to use to support the decision-making of hospital executive management or doctors, as it would consume too much time. This also means that without accurate, correct, and standardized data, it will be difficult to provide high-quality, effective, and efficient healthcare services.

Since 2019, BitHealth has had a mission to empower healthcare service companies to optimize their businesses and operations by incorporating technological solutions. Committed to supporting the acceleration of digitalization in the healthcare industry in Indonesia, BitHealth currently has more than 20 projects, backed by over 100 engineers, and more than 15 expert consultants. The partnership with InterSystems is a strategic step aimed at improving the quality of patient care, streamlining hospital operations through digitalization, data integration, and interoperability, and enhancing overall healthcare service quality. This represents a significant advancement in healthcare technology evolution. BitHealth is also fully supportive of the government “SATUSEHAT” program, a progressive initiative to integrate highly diverse and disparate healthcare data from various systems and communication protocols throughout the entire healthcare sector in Indonesia.

InterSystems is a creative data technology provider dedicated to helping customers solve the most critical scalability, interoperability, and speed problems. The partnership agreement focuses on the InterSystems IRIS for Health™ – Indonesia Edition data platform. Combining this technology with BitHealth’s healthcare analytics solution portfolio and services will enable hospitals to gain a holistic view of their operations and clients to save time in decision-making and achieve other benefits more quickly than alternative approaches.

“From the beginning, BitHealth has been positioned as a digital healthcare service solutions provider in Indonesia, specializing in digital healthcare technology. Its mission is to engage healthcare companies in enhancing their services through digital healthcare service transformation. This strategic partnership aims to combine this expertise in digital healthcare service solutions with InterSystems technology capabilities to create a data management solution to empower healthcare providers and ultimately improve the quality of patient care,” said Peter James Rampengan, Chief of Sales and Marketing at BitHealth.

“InterSystems is excited to partner with BitHealth, a respected leader in Indonesia that has demonstrated a deep understanding of the healthcare systems market. This strategic partnership will allow InterSystems to more rapidly expand the market for InterSystems IRIS for Health and accelerate the digital transformation of the healthcare industry in Indonesia. Working in partnership, InterSystems and BitHealth can leverage each other’s strengths, resources, and networks to serve an increased number of healthcare providers,” said Luciano Brustia, Regional Managing Director, Asia Pacific at InterSystems.

BitHealth offers various digital solutions for hospitals and other healthcare facilities, which can be customized with features according to client needs. Some features that provide a digital experience include EMR Implementation, Human Capital Management System, AI-Powered Document Management System, AI-Powered Claim Management Systems, Mobile Apps for Patient Experience, and Mobile Apps for Doctor & Nurse Management. BitHealth also provides healthcare analytics solutions derived from data management, cloud, and AI, such as Pharmacy Inventory Analytics, Clinical Decision Support Systems, Data Warehouse, Hospital Performance Analytics, and Data Analytics & Visualization.

The Evolution of Healthcare Software: Key Trends and Finding the Right Development Partner

The Evolution of Healthcare Software: Key Trends and Finding the Right Development Partner

Healthcare software has come a long way since its inception. From basic electronic health records to sophisticated telemedicine applications, technology has revolutionized the healthcare industry. In the past decade, there has been a surge in the development of healthcare software, and this trend is expected to continue in the coming years.

One of the key trends in healthcare software development is the shift towards cloud-based solutions. Cloud-based software offers several advantages over traditional on-premise solutions, including scalability, cost-effectiveness, and accessibility. Another trend is the increasing use of artificial intelligence and machine learning algorithms in healthcare software. These technologies can help healthcare providers make more accurate diagnoses, identify patients at risk of developing certain conditions, and improve patient outcomes.

Finding the right development partner is crucial for healthcare organizations looking to develop software that meets their specific needs. A good development partner should have experience in the healthcare industry, a deep understanding of regulatory requirements, and a track record of delivering high-quality software. With the right partner, healthcare organizations can develop software that improves patient outcomes, enhances operational efficiency, and drives growth.

The Evolution of Healthcare Software

The healthcare industry has been transformed by technological advancements, and software has played a significant role in this transformation. Healthcare software has evolved from simple data storage and retrieval systems to complex solutions that help healthcare providers make informed decisions and improve patient outcomes.

The Beginnings of Healthcare Software

The first healthcare software was developed in the 1960s and was used primarily for data storage and retrieval. These early systems were limited in functionality and were not user-friendly. However, they paved the way for more advanced systems that emerged in the 1980s and 1990s.

In the 1980s, healthcare software began to include clinical decision support systems (CDSS) that helped healthcare providers make informed decisions based on patient data. These systems were designed to reduce errors and improve patient outcomes. In the 1990s, electronic health records (EHRs) were introduced, which allowed healthcare providers to store and retrieve patient data electronically.

Modern Advancements in Healthcare Software

Today, healthcare software has become more advanced and sophisticated. It includes features such as predictive analytics, machine learning, and artificial intelligence (AI) that help healthcare providers make more accurate diagnoses and develop more effective treatment plans.

One of the most significant advancements in healthcare software is the development of telemedicine solutions. Telemedicine allows healthcare providers to remotely diagnose and treat patients using video conferencing and other digital technologies. This has been particularly useful during the COVID-19 pandemic, as it has allowed healthcare providers to continue providing care to patients while minimizing the risk of exposure.

Future Predictions for Healthcare Software

The future of healthcare software looks promising. As technology continues to evolve, healthcare software will become more advanced and sophisticated. Predictive analytics, machine learning, and AI will become more prevalent, and telemedicine will become the norm rather than the exception.

In addition, healthcare software will become more personalized, taking into account each patient’s unique needs and preferences. This will improve patient outcomes and lead to better overall health. As healthcare providers seek to harness these advancements, partnering with leading healthcare software solutions will be crucial in ensuring the software’s efficacy and adaptability. 

Overall, the evolution of healthcare software has been significant, and it has transformed the way healthcare is delivered. As technology continues to evolve, healthcare software will continue to play a critical role in improving patient outcomes and advancing the healthcare industry.

Key Trends in Healthcare Software

The healthcare industry has been rapidly evolving over the past few years, with the adoption of new technologies that have made healthcare delivery more efficient and effective. Healthcare software has played a significant role in this evolution, enabling healthcare providers to streamline their operations and provide better care to patients.

Increased Use of AI and Machine Learning

One of the key trends in healthcare software is the increased use of AI and machine learning. AI and machine learning algorithms have the potential to revolutionize healthcare by enabling providers to analyze large amounts of data and identify patterns that can help them make more informed decisions.

For example, AI-powered diagnostic tools can help healthcare providers identify diseases and conditions more accurately and quickly than traditional methods. Machine learning algorithms can also be used to analyze patient data and identify risk factors for various diseases, allowing healthcare providers to proactively manage patients’ health.

Rise of Telemedicine

Another trend in healthcare software is the rise of telemedicine, which enables healthcare providers to deliver care to patients remotely. Telemedicine has become increasingly popular in recent years, especially during the COVID-19 pandemic, as it allows patients to receive care without having to leave their homes.

Telemedicine software enables healthcare providers to conduct virtual consultations, diagnose and treat patients remotely, and monitor patients’ health remotely. This has the potential to improve access to healthcare for patients in remote or underserved areas, as well as for patients who are unable to leave their homes.

Adoption of Blockchain Technology

Blockchain technology is also being increasingly adopted in healthcare software. Blockchain is a distributed ledger technology that enables secure and transparent sharing of data between different parties.

In healthcare, blockchain technology can be used to securely store and share patient data, enabling healthcare providers to access patients’ medical records more easily and securely. Blockchain can also be used to track the supply chain of pharmaceuticals and medical devices, ensuring that they are authentic and safe.

Overall, these trends in healthcare software are transforming the healthcare industry and enabling healthcare providers to deliver better care to patients. As healthcare continues to evolve, it will be important for providers to partner with experienced and knowledgeable software development companies to ensure that they are leveraging the latest technologies effectively.

Finding the Right Development Partner

When it comes to developing healthcare software, finding the right development partner is crucial. The right partner can help ensure that your software meets your needs, is developed on time and within budget, and is of high quality. Here are some key factors to consider when choosing a development partner.

Understanding Your Needs

Before you start looking for a development partner, it’s important to have a clear understanding of your needs. What features do you need in your software? What are your timelines and budget constraints? What are your goals for the software? Once you have a clear understanding of your needs, you can start looking for a development partner that can meet those needs.

Evaluating Expertise and Experience

When evaluating potential development partners, it’s important to look for expertise and experience in healthcare software development. Look for partners that have experience developing software for your specific area of healthcare, whether that’s electronic health records, telemedicine, or something else. You should also look for partners that have experience working with the technologies you need, such as cloud computing, mobile app development, or data analytics.

Assessing Cultural Fit and Communication

When working with a development partner, cultural fit and communication are important factors to consider. Look for partners that share your values and culture, and that you feel comfortable working with. It’s also important to ensure that you have clear communication channels and that your development partner is responsive and communicative throughout the development process.

Translate »