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itechgrc · 2 months

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Gen-AI Regulations in Life Sciences: Are You Ready for the Future?

How prepared are you for the changes in generative AI regulations affecting life sciences? With rapid advancements in AI, especially in the generative sector, the life sciences industry is undergoing transformative changes. These innovations bring new opportunities and challenges, particularly regarding regulatory compliance. Understanding these regulations is crucial for stakeholders in the life sciences sector to ensure safety, effectiveness, and ethical standards.

Understanding FDA's Role

In the U.S., the FDA has taken significant steps to regulate AI in life sciences. Their guidelines focus on ensuring that AI technologies used in medical devices and healthcare applications are both safe and effective.

AI/ML-Based Software as a Medical Device (SaMD) Action Plan: The FDA’s action plan for AI and ML-based software includes a regulatory framework that supports the continuous improvement of AI algorithms. This plan includes guidance on pre-market submissions, modifications, and real-world performance monitoring to ensure the technology meets the necessary standards.

Good Machine Learning Practice (GMLP): The FDA emphasizes Good Machine Learning Practice (GMLP) to maintain the quality and reliability of AI technologies. GMLP principles such as transparency, reproducibility, and robustness are crucial for the successful deployment of AI systems in healthcare. Companies developing AI tools must adhere to these guidelines to ensure their products are compliant with FDA standards.

What’s Happening in Europe?

The European Union (EU) provides a complementary approach with its comprehensive regulatory framework focusing on the classification and management of AI systems.

The AI Act: The AI Act classifies AI systems used in life sciences, particularly those impacting patient health and safety, as high-risk. These systems must comply with strict requirements, including rigorous testing, transparency, and post-market surveillance. This ensures that high-risk AI systems undergo thorough evaluations to prevent potential harm to patients.

General Data Protection Regulation (GDPR): GDPR plays a vital role in regulating AI in the EU by ensuring that personal data used in AI systems is handled with utmost care, emphasizing data privacy and security. Compliance with GDPR is mandatory for AI systems processing personal data, making it a critical aspect of regulatory compliance in life sciences. Companies must implement robust data protection measures to comply with GDPR requirements.

WHO’s Global Guidelines

The World Health Organization (WHO) provides global guidelines for the ethical and safe development of AI technologies in healthcare.

Ethical Guidelines: The WHO’s ethical guidelines emphasize principles like transparency, accountability, and inclusiveness. These guidelines aim to ensure that AI technologies in healthcare are accessible and do not increase existing inequalities. This means AI tools should be designed to serve all populations fairly, without introducing biases that could lead to discrimination.

Safety and Effectiveness: The WHO stresses rigorous testing and validation of AI systems to ensure safety and effectiveness, including pre-market evaluations and continuous monitoring for any adverse events. This involves ongoing assessments to confirm that AI systems continue to perform safely and effectively throughout their use.

Tackling Key Challenges

Despite these robust regulatory frameworks, several challenges remain in implementing AI in life sciences.

Bias and Fairness: Ensuring that AI systems are free from bias is a significant challenge. Bias in AI can lead to unfair treatment and worsen health disparities. Regulatory bodies emphasize transparency and fairness in AI algorithms to address this issue. Companies need to implement measures to detect and mitigate biases in their AI systems.

Data Privacy and Security: With AI's increasing role in healthcare, protecting patient data has become critical. Compliance with data privacy regulations such as GDPR ensures that patient information is handled securely and ethically. Companies must invest in advanced security measures to protect sensitive data from breaches and unauthorized access.

Continuous Learning and Adaptation: AI technologies continuously evolve, and regulatory frameworks must adapt to these changes. Ensuring that AI systems remain safe and effective throughout their lifecycle, even as they learn and improve over time, poses unique challenges. This includes updating regulatory guidelines to accommodate new advancements in AI technology.

What Life Sciences Companies Can Do

Life sciences companies must take proactive steps to ensure compliance with generative AI regulations.

Establishing Compliance Programs: Developing robust compliance programs that align with regulatory guidelines is essential. This includes regular audits, risk assessments, and implementing Good Machine Learning Practice (GMLP) principles. Companies should create comprehensive compliance strategies to address all regulatory requirements effectively.

Collaboration with Regulatory Bodies: Engaging with regulatory bodies such as the FDA, EMA, and WHO can provide valuable insights and guidance, helping companies stay ahead of regulatory changes. Establishing open communication channels with regulators can facilitate better understanding and compliance with new guidelines.

Investing in Ethical AI: Investing in ethical AI practices is crucial. This includes ensuring transparency, accountability, and fairness in AI algorithms and addressing potential biases. Companies should prioritize ethical considerations in their AI development processes to build trust with users and regulators.

Continuous Monitoring and Improvement: Implementing mechanisms for continuous monitoring and improvement of AI systems is essential. This includes post-market surveillance, real-world performance monitoring, and updating AI models based on new data and feedback. Regular updates and improvements to AI systems can help maintain their effectiveness and compliance with evolving regulations.

Conclusion

Generative AI is transforming life sciences, offering immense potential for advancements in healthcare. However, staying compliant with evolving regulations is crucial. Companies need to adopt proactive measures and invest in ethical AI practices to leverage the full potential of these technologies while ensuring safety, effectiveness, and compliance.

At iTech GRC, utilizing IBM OpenPages, we specialize in providing compliance software for life sciences, life sciences risk management, GRC tools for life sciences, and life sciences audit software. As an IBM OpenPages Premier Partner, we help you ensure regulatory compliance in life sciences, making sure your AI initiatives meet all necessary standards. Partner with us to stay ahead in this rapidly evolving field and make the most of generative AI in life sciences.

#Compliance software for life sciences #Life sciences risk management #GRC tools for life sciences

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neilsblog · 3 months

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Strategic Success: Unlocking Long-Term Sustainability with a Robust Governance, Risk, and Compliance Framework

In today’s rapidly evolving business landscape, organizations face an increasingly complex array of legal, operational, financial, and compliance risks. To navigate these challenges and achieve long-term success, a strategic approach known as Governance, Risk and Compliance (GRC) is essential. A robust GRC framework not only ensures adherence to laws, regulations, and industry standards but also…

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#business #Compliance #compliance and risk management #Governance #governance risk and compliance #governance risk management #GRC #grc framework #grc platform #grc risk management #grc software #grc tools #risk management #Security

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jcmarchi · 4 months

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Data breach litigation, the new cyber battleground. Are you prepared? - CyberTalk

New Post has been published on https://thedigitalinsider.com/data-breach-litigation-the-new-cyber-battleground-are-you-prepared-cybertalk/

Data breach litigation, the new cyber battleground. Are you prepared? - CyberTalk

By Deryck Mitchelson, EMEA Field Chief Information Security Officer, Check Point Software Technologies.

Nearly everyone trusts Google to keep information secure. You trust Google with your email. I use Google for my personal email. Yet, for three years – from 2015 to 2018 – a single vulnerability in the Google Plus platform resulted in the third-party exposure of millions of pieces of consumer data.

Google paid a settlement of $350M in a corresponding shareholder lawsuit, but most organizations cannot afford millions in settlements. For most organizations, this level of expenditure due to a breach is unthinkable. And even for larger organizations with financial means, constant cycles of breach-related lawsuits are unsustainable.

Yet, across the next few years, especially as organizations continue to place data into the cloud, organizations are likely to see a significant uptick in post-breach litigation, including litigation against CISOs, unless they adopt stronger cyber security protocols.

Litigation looms large

Organizations that have experienced data breaches are battling a disturbing number of lawsuits. In particular, privacy-related class actions against healthcare providers are taking off.

Globally, there were 2X the number of data breach victims in 2023 as compared to 2022.

In 2023 alone, breach related class actions and government enforcement suits resulted in over $50 billion in settlement expenditures.

The Irish Health Service Executive, HSE, was severely impacted by a large cyber attack in 2021 with 80% of its IT services encrypted and 700 GB of unencrypted data exfiltrated, including protected health information. The HSE subsequently wrote to 90,936 affected individuals. It has been reported that the HSE is facing 473 data-protection lawsuits, and this number is expected to continue rising.

I recently spoke with a lawyer who specializes in data breach litigation. Anecdotally, she mentioned that breach-related lawsuits have grown by around 10X in the last year. This is becoming the new normal after a breach.

While organizations do win some of these lawsuits, courts have become increasingly sympathetic to plaintiffs, as data breaches can result in human suffering and hardship in the forms of psychological distress, identity theft, financial fraud and extortion. They can also result in loss of human life, but more about that later.

In courts of justice, an organization can no longer plead ‘we made an error or were unaware’, assuming that such a line will suffice. The World Economic Forum has found that 95% of cyber security threats can, in some capacity, be traced to human error. These cases are not complex. But the level of litigation shows that businesses are still making avoidable missteps.

To that effect, businesses need to not only start thinking about data protection differently, but also need to start operating differently.

Personal (and criminal) liability for CISOs

CISOs can be held personally liable, should they be found to have failed in adequately safeguarding systems and data that should be protected. At the moment, we’re not seeing much in the way of criminal liability for CISOs. However, if CISOs appear to have obfuscated the timeline of events, or if there isn’t full transparency with boards on levels of cyber risk, courts will indeed pursue a detailed investigation of a CISO’s actions.

The patch that would have fixed a “known critical vulnerability” should have been applied immediately. If the organization hadn’t delayed, would it still have been breached?

Therefore, it is in CISOs’ best interest to record everything – every interaction, every time that they meet with the board, and every time that they’re writing a document (who said what information, what the feedback was, who has read it, what the asks are), as a proactive breach preparedness measure.

If a CISO ends up in litigation, he or she needs to be able to say ‘this risk was fully understood by the board’. CISOs will not be able to argue “well, the board didn’t understand the level of risk” or “this was too complex to convey to the board”, it is the CISOs job to ensure cyber risk is fully understood.

We’re starting to see a trend where CISOs are leaving organizations on the back of large breaches, which may mean that they knew their charter, but failed to take full responsibility and accountability for the organization’s entire cyber security program.

The consumer perspective

As a consumer, I would expect CISOs to know what their job is – to understand the attack surface and to map out where they have weaknesses and vulnerabilities. And to have a program in-place in order to mitigate against as much.

But even if CISOs have a program in place to mitigate breaches, consumers can still come after them for a class action. Consumers can still argue that cyber security staff should have and could have moved faster. That they should have attempted to obtain additional investment funding from the board in order to remediate problems efficiently or to increase their operational capacity and capability to prevent the data breach.

The challenge that CISOs have got is that they’re trying to balance funding acquisition, the pace of change, innovation, and competitive advantage against actually ensuring that all security endeavors are done correctly.

A current case-study in liability

In Scottland, the National Health System of Dumfries and Gallloway recently experienced a serious data breach. The attack led to the exposure of a huge volume of Personally Identifiable Information (PII). Reports indicate that three TB of sensitive data may be been stolen. As means of proof, the cyber criminals sent screenshots of stolen medical records to the healthcare service.

As expected, a ransom demand was not paid. The criminals have now leaked a large volume of data online. Having previously worked in NHS Scotland, I find such criminal activity, targeting sensitive healthcare information, deplorable. Will we now, similar to HSE, see already constrained taxpayers’ money being used to defend lawsuits?

Liability leverage with proper tooling

CISOs cannot simply put in tooling if it can’t stand up to scrutiny. If CISOs are looking at tooling, but less-so at the effectiveness/efficacy of that tooling, then they should recognize that the probability of facing litigation is, arguably, fairly high. Just because tooling functions doesn’t mean that it’s fit for purpose.

In regards to tooling, CISOs should ask themselves ‘is this tool doing what it was advertised as capable of?’ ‘Is this delivering the right level of preventative security for the organization?’

Boards should also demand a certain level of security. They should be asking of CISOs, ‘Is the efficacy of what you’ve implemented delivering at the expected level, or is it not?’ and ‘Would our security have prevented a similar attack?’ We don’t see enough senior conversation around that. A lot of organizations fail to think in terms of, ‘We’ve got a solution in-place, but is it actually performing?’

CISOs need to approach data the same way that banks approach financial value. Banks place the absolute best safeguards around bank accounts, investments, stocks and money. CISOs need to do the same with all data.

Third-party risk

One of the areas in which I often see organizations struggle is supply chain and third-party risk. As you’ll recall, in August of 2023, over 2,600 organizations that deployed the MOVEit app contended with a data breach.

What lessons around due diligence can be learned here? What more could organizations have done? Certainly, CISOs shouldn’t just be giving information to third parties to process. CISOs need to be sure that data is being safeguarded to the right levels. If it’s not, organizational leaders should hold CISOs accountable.

If the third party hasn’t done full risk assessments, completed adequate due diligence and understood the information that they’ve got, then consider severing the business connection or stipulate that in order to do business, certain security requirements must be met.

The best litigation defense

In my view, the best means of avoiding litigation consists of improving preventative security by leveraging a unified platform that offers end-to-end visibility across your entire security estate. Select a platform with integrated AI capabilities, as these will help prevent and detect a breach that may be in-progress.

If an organization can demonstrate that they have deployed a security platform that adheres to industry best practices, that’s something that would enable an organization to effectively demonstrate compliance, even in the event of a data breach.

With cyber security systems that leverage AI-based mitigation, remediation and automation, the chances of a class-action will be massively reduced, as the organization will have taken significant and meaningful steps to mitigate the potentiality of a breach.

Reduce your organization’s breach probability, and moreover, limit the potential for lawsuits, criminal charges against your CISO and overwhelming legal expenditures. For more information about top-tier unified cyber security platforms, click here.

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tyasuite123 · 5 months

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Are You Maximizing Your Compliance Management System's Potential?

Are you overseeing your organization's compliance management system (CMS) with utmost efficiency? In today's dynamic regulatory landscape, governance, risk, and compliance (GRC) are paramount. However, without a robust e-compliance dashboard and compliance management platform, achieving optimal compliance can be challenging.

A comprehensive compliance management system ensures adherence to industry regulations, internal policies, and ethical standards. By integrating governance, risk, and compliance functions, organizations can streamline processes, mitigate risks, and enhance decision-making.

An e-compliance dashboard serves as a centralized hub, offering real-time insights into compliance status, emerging risks, and regulatory updates. It empowers stakeholders to monitor key performance indicators, track compliance activities, and address potential issues promptly.

Compliance management software automates tasks such as policy management, training tracking, and audit preparation, reducing manual errors and improving efficiency. With customizable workflows and reporting capabilities, it enables organizations to tailor compliance processes to their specific needs.

Effective compliance management requires a proactive approach, leveraging technology to stay ahead of evolving regulations and industry standards. By implementing a comprehensive TYASuite compliance management solution, organizations can foster a culture of compliance, instill trust among stakeholders, and safeguard their reputation.

Are you harnessing the full potential of your compliance management system? Embrace innovative solutions like e-compliance dashboards and compliance management software to elevate your compliance efforts and achieve sustainable business success.

#compliance management system #governance risk and compliance #e compliance dashboard #Compliance management software #compliance management

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