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Category: General

Mitigating Risks using AI

Posted on by mike

This isn’t just another theoretical discussion – it’s your roadmap to practical AI implementation in legal workflows.

What You Will Discover:

  • Real-world strategies for AI-powered legal compliance
  • Risk mitigation techniques that work in practice
  • Exclusive case study: The TensorCase AI platform in action

Perfect For Legal Professionals Who Want To:

  • Streamline compliance processes without compromising accuracy
  • Understand the current AI legal landscape across UK, EU, and US
  • Learn from actual implementation successes (and failures)
  • Balance AI efficiency with critical human judgment

Hosted by Wendy Lloyd-Goodwin, Founder & CEO of LS Law, and Lindsay Kim Chung, Co-Founder & CEO at TensorCase.  

We are also thrilled to announce that our data privacy expert, Nick Tyler, Chief Data Privacy Consultant will join the panel.  

Sharing his experience navigating AI risks and “keeping the human in the loop” in today’s fast-changing regulatory landscape. Nick is a leading expert in the field of international data protection and privacy law, with over 25 years’ experience working in the pharmaceutical and life science industry, the UK regulatory authority, and in private practice.  

 📅 Date: Tuesday April 29, 2025  

🕒 Time: 1:00 PM BST / 8:00am EDT

Wendy Lloyd-Goodwin

Wendy Lloyd-Goodwin,
LS Law CEO & Founder

Wendy is a leading expert in Pharma law. With over 20 years of experience in the pharmaceutical and biotech world, she’s built and led exceptional in-house legal and compliance teams, earning a stellar reputation for her hands-on, business-focused approach. She truly gets what a business needs and knows exactly how to build the right teams to make it happen.

Spotting a real gap in the market, Wendy founded Life Science Law—a consultancy designed to bring industry-specific legal and compliance expertise to businesses in need of flexible, tailored support. Having been a general counsel herself, she knows firsthand how tricky it can be to find legal experts with deep industry knowledge for project-based or interim work—so she created Life Science Law to solve that problem.

Lindsay Kim Chung

Lindsay Kim Chung,
Co-Founder & CEO at TensorCase

Lindsay is a visionary leader and the dynamic Co-Founder & CEO of TensorCase. With a passion for innovation and a sharp strategic mind, she is at the forefront of transforming AI-driven solutions for the life sciences and pharmaceutical industries.

With a background spanning technology, business, compliance, investigations, and litigation, Lindsay has a track record of building cutting-edge solutions that streamline operations, enhance compliance, and drive efficiency.

A true problem-solver and advocate for the power of AI, Lindsay is dedicated to helping businesses embrace the future with confidence. Whether it’s through pioneering tech or forward-thinking strategies, she’s all about making AI work seamlessly for life sciences.

The Perils and Promise of Artificial Intelligence

Posted on by mike

Artificial Intelligence (AI) is no longer the future, it is the present. From powering medical innovations to streamlining legal research, AI is revolutionising industries across the board. For lawyers in life sciences, this cutting-edge technology offers both incredible opportunities and sobering risks, and as with any emerging tool, understanding how to navigate its complexities is the key to using it responsibly and effectively.  

The Risks: AI’s Shadowy Side 

AI may be the belle of the technological ball, but even the most dazzling star has its dark side. For lawyers, particularly those navigating the intricate waters of life sciences, there are some key areas to watch: 

  1. The Danger of Imperfect Accuracy

    AI thrives on data, mountains of it, but not all data is created equally. If the information fed into an AI system is flawed or biased, the results will be too.  

  2. The Confidentiality Conundrum

    Lawyers are the custodians of secrets, and rightly so. Sharing sensitive client information with an AI platform—especially one hosted by a third party. 

  3. The Accountability Maze

    If AI suggests a course of action and it all goes pear-shaped, who is responsible? The lawyer? The developer? The robot itself? The legal profession thrives on clarity and accountability, these grey areas pose an ethical dilemma for practitioners who must remain accountable for the advice they provide. 

  4. Over-Reliance on AI

    Technology is a wonderful assistant but a dreadful master. Context is critical when providing legal The all-important human touch; intuition and creativity cannot be replicated by AI.

The Bright Side: AI’s Benefits  

But do not let the risks scare you away. AI, when used wisely, is the most marvellous tool in a lawyer’s arsenal. For those of us in the life sciences sector, its potential is as thrilling as a first-class ticket to space! 

  1. Enhanced Efficiency

    AI can process vast quantities of information in a fraction of the time it would take a human. For lawyers, this means faster due diligence, document review, and compliance checks, especially important for life science lawyers and compliance professionals, where time is often of the essence. 

  2. Unparalleled Precision

    AI is splendid at spotting patterns and detecting errors that might elude even the sharpest human eye. With the right oversight, AI can help reduce human error and boost the precision of legal work. 

  3. Cost-Effective Brilliance

    Let’s face it, clients rightly demand value for money. By automating repetitive tasks, AI allows lawyers to focus on the cerebral, strategic work that clients truly appreciate, all while trimming the billable hours.  

  4. Staying Ahead of the Curve

    Embracing AI isn’t just about keeping up; it is about leading the charge. Life sciences is a fast-moving, competitive field, and those who use AI effectively will dazzle, while those who don’t may find themselves left in the dust. 

So, is AI a risky business for lawyers? Absolutely, but only if you let it be. The trick, as with all things, is balance, and transparency. 

Adopt AI thoughtfully. Use it as an ally, not a crutch. Ensure the tools you choose comply with privacy laws and ethical standards; and above all, remember that no machine can replace the unique human qualities that make you a brilliant lawyer; your judgment, creativity, and understanding of nuance. 

As a lawyer in life sciences, your role is already at the intersection of technology, ethics, and human welfare. AI is simply the next evolution of that intersection. While it is natural to approach new tools with caution, remember that innovation and progress often come from taking informed, calculated risks. By leveraging AI responsibly, you can not only improve your practice but also help shape a future where law and science work hand in hand to solve some of humanity’s most pressing challenges. 

We are continuously monitoring the developments in the governance of Artificial Intelligence, and what this means for our sector.  Please do not hesitate to contact us if you require any assistance in preparing for the implementation of the AI Act or in reviewing and updating your policies and procedures to ensure compliance with data protection laws in the AI context. 

20th November 2024 Update

Posted on by Rosie

Advertising

UK

  • The Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance for promotional material within the context of the Windsor Framework. See Guidance for further information. The Medicines and Healthcare products Regulatory Agency (MHRA) has also published its own MHRA guidance providing information on the implementation of changes to advertising and promotion of medicines authorised in the UK from 1 January 2025.
  • The MHRA has published decisions made by the MHRA following investigations into complaints about advertising for licensed medicines. See July , August and September decisions for further information.

Artificial Intelligence

EU

  • JRC has published harmonized standards for the EU AI Act. See here for further information.
  • The European Commission’s AI Office has launched a consultation on the AI Act prohibitions and AI system definition. The consultation is open until 11 December 2024. For further information on the consultation and how to submit a response please see press release and here
  • The European Commission has published a Q & A document on general purpose AI. See here for further information.

Brexit

UK

  • The MHRA has issued a second webinar in a two-part series on preparation for the Windsor Framework implementation. See Windsor Framework Webinar Recordings here for further information.

Clinical Trials

UK

  • In a webinar on 15 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) stated that it expects the new UK clinical trial regulation to be implemented by January 2026. A recording of the webinar on plans to implement the new Clinical Trials Regulations is now available. See here for further information.
  • The NHS Health Research Authority (HRA) has published a new draft model Commercial Chief Investigator Agreement and is seeking feedback on the draft model agreement. For further information, including a copy of the draft agreement and how to provide feedback, see here
  • The HRA has published a new toolkit for supporting research carried out across borders in the UK. The aim of the toolkit is to make it easier to set up research across the UK. See here for further information.
  • The MHRA has announced a consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2. The consultation is open until 14 February 2025. See here for further information.

Switzerland

  • On 1 November 2024 a new Swiss clinical trials framework takes effect. See here for further information.

Competition Law

EU

  • The European Commission has fined Teva EUR 462.6 million for abusing its dominant position to delay competition to its blockbuster medicine for the treatment of multiple sclerosis. The Commission found that Teva had misused the patent system and disparaged a rival’s product to hinder market entry. See European Commission press release for further information.

EU/UK

  • The EU and UK have agreed a new competition cooperation agreement. The agreement will allow the Commission, the national competition authorities of the EU Member States (‘NCAs’) enforcing EU competition law, and the UK Competition and Markets Authority (CMA) to cooperate directly in competition investigations. See EU press release and CMA press release for further information. 

Competitiveness

EU

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has just published a report it commissioned showing the EU R & D pharmaceutical spending across member states and a comparison of spending in other regions across the globe, such as the US and China. For further information see here

Data Privacy

EU

  • The European Data Protection Board (EDPB) has adopted a report on a first review of the European Commission Implementing Decision on the adequate protection of personal data under the EU-US Data Privacy Framework. See Report for further information.

UK

  • The Information Commissioner’s Office (ICO) has issued key data protection considerations to be taken into account when using AI to assist with recruitment. See ICO  data protection considerations document for further information.

Health Data

EU

  • The European Medicines Agency (EMA) has opened a consultation on the draft European Medicines Agencies Network Data Strategy – Increasing the value of data for the benefit of public and animal health. The consultation is open until 31 December 2024. See here and here for further information.

UK

  • The Sudlow Review, an independent review of the UK health data landscape, titled ‘Uniting the UK’s Health Data: A Huge Opportunity for Society’, was published on Friday 8 November 2024. The Review is available The Association of the British Pharmaceutical Industry (ABPI) and the HRA have both commented on the review and their responses are available here and here

Innovative Medicines

UK

  • The MHRA has published a statement of policy intent, setting out plans for the relaunch of the Innovative Licensing and Access Pathway (ILAP). The ILAP focuses on getting new transformative medicines to patients more quickly. See here for further information and the statement of policy intent.

Intellectual Property

UK

  • The Supreme Court has ruled in the Sky v Skykick case, overturning the Court of Appeal on key aspects of bad faith, which will have implications for trade mark filing and enforcement. See judgement for further information.
  • The Intellectual Property Office (IPO) has published statutory guidance on changes to supplementary protection certificates (SPCs) from 1 January 2025, when new legislation on SPCs comes into force. See statutory guidance for further information.

Market Access

EU

  • The European Commission has published the third of six Regulations implementing the Health Technology Assessment Regulation (EU) 2021/2282. The third Implementing Regulation sets out rules for the management of conflicts of interest of those involved in joint clinical assessments and joint scientific consultations. See Implementing Regulation for further information.
  • EFPIA has published two blog articles on joint clinical assessments under the Health Technology Assessment Regulation. See blog article and blog article for further information.

Medical Devices

UK

  • The MHRA has announced a consultation on the Medical Device Regulations: routes to market and in vitro diagnostic devices (IVDs). The consultation is open until 5 January 2025. For further information on the consultation and how to provide feedback see here
  • The MHRA has launched a consultation on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. The consultation will focus on four key policy areas, including UKCA marking, international reliance, IVDs and assimilated EU law. The findings from this consultation will inform the new law. The consultation is open until 5 January 2025. See here for further information.

Orphan Medicines

EU

  • The European Court of Justice (CJEU) has issued a judgement relating to orphan market exclusivity. The judgement considers the scope of the ‘clinical superiority’ criteria which can provide for a derogation to orphan market exclusivity. See judgement in Case C – 237/22 P for further information.

Urban Wastewater Treatment Directive

EU

  • EFPIA has issued a joint statement from the human pharmaceutical industry on the Urban Wastewater Treatment Directive. See press release for further information.

 

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

You can also stay informed and ahead of the curve by subscribing to our newsletter and following us on LinkedIn.

Managing Your In-House Legal Career in Life Sciences: Expert Insights

Posted on by Rosie

Navigating and Managing Your In-House Legal Career in Life Sciences: Insights from Industry Experts 

In our latest LawCast, Life Science Law explored some essential guidance to those looking to build and thrive as an in-house lawyer or compliance professional within the life sciences industry. Hosted by Wendy Lloyd-Goodwin, founder of Life Science Law, and joined by Rebecca Clothier, a solicitor with over 20 years of experience leading legal teams within the pharmaceutical industry. 

Rebecca has an extensive background, having worked in both private practice and in-house roles, allowing her to provide a wealth of knowledge for anyone looking to succeed in similar environments. Wendy and Rebecca discussed key strategies for managing a successful in-house legal career, including transitioning from private practice, understanding the industry, and positioning yourself for long-term career growth. 

Transitioning from Private Practice to In-House: A Mindset Shift 

One of the biggest challenges Rebecca faced early on was transitioning from private practice into an in-house legal role. As she explained, “It is a huge shift—not just in understanding the business you’ve just moved into, but also in adopting a new mindset. You move from purely legal approaches to finding pragmatic, business-oriented solutions to problems.” 

In private practice, perfection and rigorous legal analysis are paramount, but in-house lawyers must balance that precision with practicality. “Not everything has to be perfect in-house,” she advises. “You need to learn to listen, be humble, and remember that you are not the person who knows the most about the business. The key is to see things the way the business sees them and provide your legal advice within that context.” 

Becoming a Strategic Partner to the Business 

Rebecca emphasises the importance of understanding the unique aspects of the life sciences industry, including the need to incorporate industry codes and regulations into legal advice. “It is critical to tailor your guidance to the realities the business faces,” she explains. “Knowing the acronyms and industry-specific terminology, like navigating an impenetrable castle, is essential. Ask questions, and don’t be afraid to ask the business to explain the scientific rationale behind decisions.” 

A vital piece of advice she shares for junior lawyers is to build close relationships with the medical teams. “The medics understand the science, and you need to work as partners. They will help deepen your understanding of the products and the industry.” This partnership is crucial not only for providing relevant legal advice but also for fostering a collaborative environment where challenges are tackled together. 

Conquering the ‘Detached Lawyer’ Stereotype 

In-house lawyers can often be seen as disconnected or unapproachable. Wendy is quick to point out the need to overcome this reputation. “Do not be the detached lawyer,” she says. “People often perceive us as unapproachable before we even open our mouths.”  

It is so important to conquer those challenges together with your colleagues. You want your advice to be accepted, but to achieve that, you need to bring the business along with you. By active listening, proactive communication, and conveying legal advice in ways that are easy for non-lawyers to understand are vital skills.  

Balancing Risk and Making Smart Decisions 

A key part of in-house legal work is balancing risks. Rebecca explains that while private practice lawyers might present a black-and-white analysis of the law, in-house lawyers need to work within “shades of grey.” “You need to get to a place where you’re helping the business make smart, informed decisions. That often means explaining the risks but allowing the business to decide if they’re willing to take them.” 

Managing expectations is also critical. Be clear on timelines and communicate them effectively. Things can’t be done instantly, and it’s okay to rely on others for assistance. These are skills we all need to develop. 

Navigating Career Progression 

One challenge many in-house legal professionals face is the limited opportunities for promotion, especially in smaller teams. It can be difficult to get promotions because there just aren’t that many senior roles in a small in-house team. But moving companies isn’t always the right answer. 

Rebecca suggests focusing on what you can do within your current role to position yourself for success. “Ask yourself, what do I need to do to be seen as the number one candidate for the role I want? Don’t be afraid to think about what you love doing, rather than assuming the next step in your career must be a predefined path.” 

Building Your Brand and Network 

When asked for a key piece of advice for those entering the life sciences sector, Rebecca stresses the importance of building your personal brand and network. “Learn to market yourself, not in a showy way, but in a way that builds trust and demonstrates your expertise over time. Make good connections and network. These relationships can be invaluable to your long-term career success.” 

Navigating a legal career in the life sciences sector presents unique challenges and opportunities. As Rebecca’s experience shows, success lies in transitioning your mindset from pure legal analysis to a more holistic, business-focused approach. Building relationships, understanding industry specifics, managing risks, and growing your personal brand are all essential steps in this journey. 

We hope that these insights have provided practical advice and inspiration for managing your in-house legal career. If you have any questions or would like to share your own experiences, please reach out to us at Life Science Law events@lslaw.mhwddev.co.uk. Your story could be featured in a future episode. 

https://lslaw.mhwddev.co.uk/podcasts/managing-your-career-in-house/  

2nd October 2024 Update

Posted on by Rosie

Artificial Intelligence 

EU 

  • The European Parliamentary Research Service (EPRS) has published a proposal for a directive on adapting non-contractual civil liability rules to artificial intelligence (AI). See the directive proposal here 

Netherlands 

  • The Dutch data protection authority has called for feedback on manipulative and exploitative AI systems under the AI Act. See here for further information. 

UK 

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has opened applications from manufacturers and developers of AI medical devices to join its AI Airlock regulatory sandbox. See here and here for further information. 

Clinical Trials 

EU 

  • The European Medicines Agency (EMA) has published a reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation. See EMA reflection paper and further information here 

Codes of Practice 

UK 

  • The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for the pharmaceutical industry. See press release and Code of Practice for further information.
  • The PMCPA has ruled that Moderna has brought discredit on the pharmaceutical industry in two separate cases. The first case related to the use of social media to recruit children into a clinical trial using unapproved financial incentives – See AUTH/3886/3/24 . The second decision related to allegations regarding the promotion of Spikevax, which occurred prior to Moderna becoming a member of the ABPI – See AUTH/3746/2/23 

Competition Law 

UK 

  • The Competition and Markets Authority has provided an update on its market investigation into the veterinary services market for household pets in the UK. It has appointed a new advisory panel to provide clinical and practical insight and analysis. See press release for further information. 

Data Privacy 

Belgium 

  • The Belgium data protection authority has published guidance on AI and data protection. See guidance for further information. 

EU 

  • The Court of Justice of the European Union (CJEU) has issued a judgement on the corrective powers of data protection authorities in the event of personal data breaches. See judgement for further information. 

Health Data 

EU 

  • The European Commission has published guidance on the Data Governance Act, a key part of the European strategy for data. For further information see the  guidance document
  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted key challenges and suggestions that should be taken into account when implementing the opt-out mechanism in the proposed European Health Data Space (EHDS) framework.  See EFPIA statement for further information. 

Health Technology Assessment 

EU 

  • The European Commission has published guidance on the validity of studies for joint clinical assessments under the EU Health Technology Assessment Regulation. See  Guidance for further information.
  • The European Commission has updated its rolling plan on the implementation of the Regulation on health technology assessment. See here for further information.
  • The European Commission has launched an online public consultation on the draft implementing act on joint scientific consultations on medicinal products for human use at Union level under the Health Technology Assessment (HTA) Regulation. The online consultation is open until 29 October 2024. See here for further information including details of how to contribute to the consultation. 

Medical Devices 

Northern Ireland 

  • The recent implementation of a submission route for manufacturers for performance studies has now enabled the submission and approval of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland. See MHRA press release for further information. 

UK 

  • The MHRA has updated its guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. See here for further information. 

Medicine Shortages 

France 

  • The French National Agency for the Safety of Medicines and Health Products (ANSM) has fined 11 pharmaceutical companies a total of 8 million Euros for failing to comply with regulations to prevent drug shortages.  French legislation now requires companies to maintain a minimum safety stock of four months for essential medicines to secure their supply if the medicines have been subject to shortages in the last two years. See ANSM press release (in French) for further information. 

Pharma Reform

EU 

  • EFPIA has published a blog article on the challenges and importance of establishing criteria for unmet medical needs as part of the ongoing revision of the General Pharmaceutical Legislation. See EFPIA article here 

Patient Safety 

Germany 

  • The German Federal Social Court (BSG) has ruled in connection with a question of whether persons insured under the statutory health insurance system are also entitled to a medicinal product that has been negatively assessed by the European Medicines Agency (EMA) during the marketing authorisation procedure as part of their treatment for a fatal disease. The court ruled that the purpose of the medicinal products authorisation is to protect patients with serious illnesses from incalculable risks. The German Medicinal Products Act also provides a structured quality assurance system, providing simplified approvals and exceptions in case of hardship but if a case fell outside the exceptions in the Act, then no further exception could be granted. See judgement (in German) for further information. 

UK 

  • The MHRA has introduced a new strategy for improving safety communications. The strategy aims to transform the way we provide information on the risks and safety of medicines and medical devices. See MHRA press release for further information. 

Pricing and Reimbursement 

UK 

  • The Board of the National Institute for Health and Care Excellence (NICE) has determined that the severity modifier, which was introduced to allow extra weight to be given to medicines that address severe diseases, is working as intended. The Board has agreed to continue monitoring the severity modifier’s introduction. See NICE press release . However, the ABPI has released a statement indicating its disappointment that NICE has decided not to change how it values medicines for those with severe conditions. See ABPI statement for further information. 

Regulatory

EU 

  • EMA has published its Human Medicines Highlights with information on new medicines approved. See Newsletter here 

 

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

You can also stay informed and ahead of the curve by subscribing to our newsletter and following us on LinkedIn.

Mastering the Clock

Posted on by Rosie

In the latest episode of the podcast Mastering the Clock, Wendy Lloyd-Goodwin, Founder and CEO of LS Law, shares her deeply personal journey of balancing the demands of a legal career with the responsibilities of being a single parent. Her story is one of resilience, determination, and the ongoing challenge of mastering time management—a skill she honed out of necessity and continues to refine as she navigates the complexities of leading her own business. 

The Beginning of the Journey 

Wendy’s law journey began with added responsibilities that few of her peers had to manage—she was not only a dedicated student but also a single parent. The need to balance work and life was not just a concept but a daily reality, even during her university years. This balance was crucial, yet challenging, as she strove to excel academically while being a present and supportive mother. 

One of the most difficult decisions Wendy faced early in her career was to keep her family situation private while pursuing a training contract. She was keenly aware that this added layer of responsibility could be seen as a disadvantage in a highly competitive field. The pressure to perform at work, while managing a household, added stress that required her to be exceptionally organized and disciplined. 

The Struggle for Balance 

Wendy’s approach to time management during those early years was both practical and intense. Her days were meticulously planned—childcare arrangements, university schedules, and household responsibilities all had to fit into a tight routine. At the office, she was all business. Wendy’s focus on work was so intense that she often skipped lunch breaks, choosing instead to stay at her desk. While this level of commitment helped her succeed, it also highlighted a critical flaw in her approach: the lack of a sustainable work-life balance. 

Her routine included keeping a detailed diary, where every meeting was scheduled and checked, then double-checked. This rigorous approach ensured she stayed on top of her responsibilities, but it also left little room for rest or personal care. 

Evolving Challenges 

As Wendy transitioned from being a lawyer to starting her own business, the challenges of work-life balance became even more pronounced. The structured deadlines of school runs and childcare were replaced by the endless demands of entrepreneurship. Without those external markers to signal the end of a workday, Wendy found herself at risk of working around the clock. 

Today, Wendy acknowledges that achieving work-life balance is harder than ever. The absence of fixed deadlines means that she could, in theory, work 24/7—a temptation that many business owners face. However, she has also recognized the importance of taking deliberate steps to protect her well-being. 

Tips for Achieving Balance 

  • Value Yourself: It’s essential to prioritise your own well-being. Exercise regularly, eat well, and remember that these disciplines will positively impact your work.
  • Take Breaks: Even a short, 10-minute walk during lunch can be incredibly refreshing. It’s important to step away from your desk and recharge.
  • Schedule Personal Time: Plan out at least one day each month for self-care activities, like a spa visit or spending time with a friend. Being kind to yourself is not just a luxury; it’s a necessity.
  • Be Accountable: A coach can be invaluable in helping you stay on track. The process of talking things through provides clarity, turning a tangled “ball of spaghetti” into a manageable set of challenges.
  • Surround Yourself with Support: Share your vulnerabilities with trusted friends. They can help keep you grounded and remind you of your goals. 

Ultimately, mastering the clock is about more than just managing time—it’s about managing yourself. By recognising the importance of self-care, seeking support when needed, and being deliberate about how you spend your time, you can achieve a balance that supports both your personal and professional life. Wendy’s journey is a testament to the power of resilience, organisation, and the willingness to continuously learn and adapt. 

 

“Mastering the Clock,” with Lisa Levine and Wendy Lloyd-Goodwin. Join us as Wendy and Lisa offer practical strategies and share their experiences to help you master your time and achieve a better work-life balance.

AI : Privacy Risks and How to Remain Compliant

Posted on by Rosie

In this article we once again focus on artificial intelligence, but this time looking at some of the key data privacy issues arising with the use of AI tools and what in-house lawyers need to consider to ensure data protection compliance. 

The EU AI Act, which came into force on 1st August 2024, is essentially a product safety law, providing for the safe development, deployment and use of AI systems. Both the EU and UK General Data Protection Regulations (GDPR) on the other hand give individuals fundamental rights in relation to the processing of their data. Although these two sets of laws are intended to dovetail each other, there are inevitable tensions created between the development and use of AI tools and application of data privacy laws. In fact, it is probably fair to say that data protection risks have considerably increased and the application of GDPR has become considerably more complex with the advancement in AI technology and its use to process personal data. 

The opportunities and benefits from AI may be far reaching, but as AI tools increasingly encroach on all areas of our lives, the concerns about the potential for loss of control over our personal data are real. AI tools use significant amounts of data to operate, learn and continuously improve, sourcing data from a vast array of different sources, including social media, scraping from the internet and voice assistants, to name but a few. These data sources inevitably contain large quantities of personal information and given the broad definition of personal data under European data protection laws, the development and use of an AI system will most often result in the processing of personal data. This raises the inevitable question as to how AI tools can lawfully process this personal information- and what is the legal basis for processing this data?  

AI tools process personal data in different ways and for different purposes, so it is essential, prior to processing personal data, to determine what personal data is being used, the purpose for which it is being processed and the lawful basis upon which it is being handled. As AI systems have a broad potential range of applications (from recruitment processing, recording meetings, clinical trial eligibility assessments, to name but a few) it may be difficult to determine the lawful basis upon which it can be used. Likewise, relying on ‘legitimate interests’ (personal data is being processed to carry out a legitimate interest, and the rights and interests of the data subject do not outweigh those interests) as a catch all lawful basis for processing may not be so straightforward and will ultimately depend on the purpose for which the AI tool is to be used, and the type of personal data being processed. Carrying out a legitimate interest assessment (LIA) Sample LIA template (Word) prior to any processing is therefore essential.   

Further complexities arise when AI tools process personal data which involves automated decision making or profiling or which involves special category data. In these scenarios it may be difficult to determine a lawful basis for processing and the only solution may be to obtain explicit consent to the processing – a complicated task in itself.  

As well as ensuring there is a lawful basis for processing the data, any processing must also be fair and transparent. The potential for bias with AI systems is well documented but fairness in processing personal data is a prerequisite, so it is essential the AI system is statistically accurate and avoids discrimination/bias. Additionally, controllers are obliged to inform data subjects what will be done with their data. Since AI tools use complex algorithms, explaining decisions made by AI is not straightforward. Whilst transparency requirements have frequently been fulfilled by the provision of a privacy notice, it is likely that explainability statements, which seek to explain how the AI system makes decisions, will become more commonplace. In the UK, the Information Commissioner’s Office (ICO) has issued guidance on Explaining decisions made with AI , which is a useful reference to assist in this regard. 

It is perhaps worth mentioning that in addition to the requirements of GDPR, the EU AI Act also imposes transparency requirements, most notably on providers of high-risk AI systems, (some transparency requirements also apply to deployers). Regulators are being increasingly proactive in taking steps against organisations for lack of transparency when processing data using AI tools (e.g. Italian data protection authority’s investigation into ChatGPT). The direction of travel seems clear therefore: existing transparency requirements under GDPR are strengthened by the EU AI Act and data protection regulators are increasingly focusing their efforts to enforce data protection obligations where AI technologies are used to process personal data. 

In addition to ensuring that the processing of personal data in an AI context is fair, lawful and transparent, other important data protection issues which arise with the use of AI tools include: 

  • Purpose limitation – where AI tools use data for multiple purposes, a major tension exists in ensuring that personal data is collected for “specified, explicit and legitimate purposes” only and not further processed in a way which is incompatible with those purposes.
  • Data minimisation – how will it be possible to ensure that a vast and expanding data set adheres to the data minimisation principle that requires you to identify the minimum amount of personal data you need to use for your purpose, and to only process that information, and no more?
  • Storage limitation – since AI tools arguably become more effective, the more data they are trained on, it seems likely that there will be a tendency to hold on to data on a long-term basis. Such indefinite data retention without appropriate justification breaches the storage limitation principle in GDPR. It will therefore be important to demonstrate compliance in this area with appropriate policies and audit trails to appropriately justify retention and/or evidence deletion.
  • Minimising risks of privacy attacks on AI Tools – AI systems can increase security risks and make them more difficult to manage. With an increased security risk profile likely with AI system use, it is essential to ensure that risk management practices are reviewed and appropriate additional technical security measures adopted to ensure personal data is secure in the AI context. The right approach to security will depend on many factors including the types of risk and specific processing activities undertaken. In the UK, the ICO has published  guidance to assist in assessing and managing the risk of privacy attacks in an AI context. 

With the use of AI continually evolving, it is essential to understand data privacy implications arising from the use of AI tools. Adopting the right approach to demonstrate compliance and adapting this approach as technology develops will be key. In this regard, it is recommended to:   

  1. Undertake (and keep up to date) a detailed risk assessment to understand all uses of AI, which data subjects are affected and consider the wider regulatory requirements;
  2. Review and update data privacy policies and procedures, considering how to demonstrate compliance with data protection laws in the AI context i.e. the need for comprehensive data protection impact assessments (DPIAs) will almost always be required but these will also be essential to demonstrate compliance to a regulator; 
  3. Raise awareness and educate the wider business about data protection risks in the context of AI, how data is used in AI tools and the sources of data;
  4. Ensure that data protection compliance in the AI context is given sufficient prominence in the business, including at senior management level in order to set the tone from the top;
  5. Keep up to date with and review the latest guidance from regulators. The ICO for instance has developed several guidance documents. See here and here for further information;
  6. Keep up to date with enforcement decisions from regulators. These often provide valuable guidance. For instance, the recent ICO decision on Snap’s My AI contained useful commentary on the ICO’s expectations as to the level of detail to be included in DPIAs in general and observations on particular areas of concern when engaging with genAI and children.  

 

We are continuously monitoring the developments in the governance of Artificial Intelligence, and what this means for our sector.  Please do not hesitate to contact us if you require any assistance in preparing for the implementation of the AI Act or in reviewing and updating your policies and procedures to ensure compliance with data protection laws in the AI context. 

12th August 2024 Update

Posted on by Rosie

Competition Law

UK

  • The Competition and Markets Authority (CMA) is reviewing the Assimilated Technology Transfer Block Exemption Regulation (Assimilated TTBER) to inform the CMA’s recommendation to government on whether to replace the Assimilated TTBER on its expiry on 30 April 2026. The consultation is open until 6th September 2024. Further details of the review and how to respond to the consultation can be accessed here

Data Privacy

UK

  • The Information Commissioner’s Office (ICO) has issued a provisional decision to impose a £6 million fine on a software provider following an August 2022 ransomware attack which disrupted NHS and social care services. Personal information belonging to 82,946 people was stolen following the attack. See here for further information.

 

Health Data

UK

  • The Association of the British Pharmaceutical Industry (ABPI) has responded to the government’s commitment to boost research by improving access to health data. See ABPI response for further information.

Intellectual Property

UK

  • The Court of Appeal has handed down its judgement in Comptroller – General of Patents, Designs and Trade Marks v Emotional Perception AI Limited [2024] EWCA Civ 825 , overturning the decision of the High Court and upholding the findings of the UKIPO Hearing Officer. Emotional Perception’s patent application for an AI music recommendation neural network was refused by UKIPO as a computer program “as such”, and therefore excluded from patentability under s.1(2) of the Patents Act 1977. The decision once again puts the spotlight on the patentability of AI inventions. Emotional Perception has indicated that it plans to appeal the decision to the Supreme Court.

US

  • The United States Patent and Trade Mark Office (USPTO) has issued a guidance update on patent subject matter eligibility to address innovation in critical and emerging technologies, including in artificial intelligence (AI). See press release and guidance for further information.

Manufacturing

EU

  • The European Medicines Agency (EMA) has released a draft guideline on information which the agency expects to see in submissions seeking EU marketing authorizations for new or existing active substances used in medicinal products. The deadline for comments is 31st January 2025. See draft guideline for further information.

Medical Devices

EU

  • EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the EU. The programme offers free advice from the medical device expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation. See EMA press release for further information.

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its Guidance on registering medical devices to place on the market. See updated Guidance for further information.

 

  • The MHRA has updated its Guidance on notifying the MHRA about carrying out a clinical investigation for medical devices. See updated Guidance for further information.

Medicines Shortages

EU

  • EMA has published further information on the European Shortages Monitoring Platform (ESMP), which has been set up to gather information about medicine supply and demand in order to prevent, detect, and manage human medicine shortages in the European Union (EU) and European Economic Area (EEA). Details of planned communication initiatives with key stakeholders and guidance and training materials to support stakeholders have now been published. See here for further information.

 

  • Ursula von der Leyen has announced an intention to introduce a Critical Medicines Act to address medicines shortages. The European Commission’s Political Guidelines for the next European Commission 2024-2029 state “We must make our economy more resilient and less dependent. This is notably important in the health and pharmaceutical sector. The EU has been confronted with severe shortages of medical devices and medicines, with antibiotics, insulin, painkillers and other products becoming particularly difficult to obtain. To remedy this, we will propose a Critical Medicines Act to reduce dependencies relating to critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries.”

UK

  • The MHRA has updated its List of medicines that cannot be exported from the UK or hoarded. For further information see

Pricing and Reimbursement

UK

  • The National Institute for Health and Care Excellence (NICE) has issued positive guidance recommending the use of exagamglogene autotemcel (CASGEVY™) in the NHS. The recommendation follows conclusion of a reimbursement agreement between Vertex (the manufacturer of CASGEVY™) and NHS England for eligible transfusion-dependent beta thalassemia (TDT) patients to access the CRISPR/Cas9 gene-edited therapy. CASGEVY™ received the first authorization in the world for a CRISPR-based gene-editing therapy on November 15, 2023. See NICE press release and Vertex press release for further information.

Regulatory

EU

  • EMA’s human medicines committee (CHMP) recommended 14 medicines for approval and 11 medicines for extensions of therapeutic indications at its July 2024 meeting. See Meeting Highlights for further information.

 

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

You can also stay informed and ahead of the curve by subscribing to our newsletter and following us on LinkedIn.

Burn Out, Are You There Yet?

Posted on by NaomiJ

From the title of this article, I am sure you have already answered the question raised at the beginning “Burn Out, Are You There Yet?”.

Our answers may vary—some of you probably silently screamed “yes!” while others have had to leave positions due to stress. Perhaps you are aware of people struggling around you, or you feel you might be headed toward burnout yourself. Whatever your thought process, know that you are not alone. This isn’t just a problem facing our industry but one that affects the corporate world and beyond. Our aim is to assist you in navigating this issue, whether you are a leader, manager, or junior. At Life Science Law we want to talk not only about educational information and provide updates in our industry but also about potentially uncomfortable subjects, which is why our first Lawcast is hosted by Wendy Lloyd-Goodwin, founder of LS Law, and Executive Transformational Coach, Lisa Levine. The conversation centers on the crucial role of creating a positive “safe space” workplace culture, where employees are encouraged to celebrate both failures and successes, and where avenues for enhancing mental well-being are readily available. It is well worth a listen. These elements are foundational aspects that Wendy has incorporated into the fabric of LS Law.

 

What is the Importance of Coaching?

From the mental health epidemic, and the prevalence of burn out in the workplace. It is important we not only understand how these issues are affecting us but provide some hints and tips on how to manage and prevent this from taking place.

Awareness of your stress levels is vital, and when we recognise the symptoms in ourselves or those around us, we take actions in managing them, which could include coaching. Just like finding the perfect pair of jeans though, it’s all about the right fit! So just because one coach or method hasn’t been successful, the search continues. Remember, sometimes the best recommendations come from your friends and professional network. So, don’t be shy—ask around and find those experienced, qualified professionals who truly understand and meet your needs.

As part of Life Science Law’s commitment to fostering growth and wellbeing, we are offering our consultants a free 30-minute chemistry session with Lisa for those that are interested in exploring whether coaching is right for them. This session provides an opportunity to assess alignment and compatibility, and to explore whether coaching with Lisa would be a good fit. If you are interested in finding out more, please apply here.

 

The Importance of Creating a Positive Workplace Culture

A company culture built on respect, trust, and collaboration turns teamwork and communication into a more effective organisation. It’s in this kind of supportive atmosphere that creativity and innovation really blossom, as employees feel safe to share their ideas and take bold risks.

Additionally, a positive workplace culture positively impacts employees’ mental and physical well-being, resulting in lower stress levels, reduced absenteeism, and a healthier work-life balance. It’s a win-win for everyone!

Moreover, leaders who prioritise work-life balance by offering flexible arrangements and respecting personal time demonstrate a commitment to employee well-being, enhancing overall job satisfaction and productivity. It’s about empowering each employee to reach their full potential and tackle whatever comes their way. That’s how you build a team that’s ready to take on the world!

 

How to Foster Effective Coaching and a Positive Workplace Culture

“Burn Out, Are You There Yet?” with Lisa Levine and Wendy Lloyd-Goodwin is a must-listen for any organisation aiming to enhance its workplace culture and coaching practices. LS Law remains dedicated to these areas, showcasing the significant advantages of investing in people. By implementing the principles discussed in both this article and in our podcast, organisations can foster a more positive, productive, and fulfilling work environment that drives success while promoting the well-being of all employees.

 

AI Governance: Are You in Control?

Posted on by Rosie

Here at LS Law, we continue to be immersed in looking at the impact of AI on our life sciences sector and we recently held a lively discussion forum with our consultants to explore the key risk factors of AI in life sciences organisations and the practical steps needed to manage those risks. What came out of that discussion was both illuminating and daunting, as we were left wondering whether AI governance and risk management is really being given sufficient priority at this time. As one of our consultants put it:

“It is really quite scary. I know there will be focus on compliance with the EU AI Act, as deadlines loom, much like with GDPR, but that isn’t the point. The reality is that the risks of AI exist now and pervade right across and to the heart of the business and responses to risk management are not joined up. There needs to be holistic governance on this issue. It isn’t enough just to be concerned about compliance with the legislation or regulatory guidance, or to believe the use of technical controls alone to address security risks will suffice, or to determine there are no issues with using AI in medicines research simply because an exemption in the AI Act for scientific research and development applies to medicines development. There needs to be an overriding understanding of how AI works and is being used right across the organisation and full consideration given to its impact now and in the future: the indirect, sometimes hidden risks that using AI can create, so that a coordinated approach and overarching framework can be created to fully manage those risks and protect the organisation. I really worry about how we are currently protecting our confidential information and intellectual property rights and the impact on privacy for instance.”

Much has been made of the AI Act, which aims to ensure that AI systems in the EU are safe and respect fundamental rights, whilst supporting innovation and investment in AI. The Act takes a risk-based approach, defining four categories of risk for AI systems and imposing a range of obligations on different operators depending on the level of risk, to ensure protection of fundamental rights. At societal level therefore, the AI Act provides a set of harmonised rules to protect safety and fundamental rights, but what it very much does not do is provide a one-stop-shop for legal compliance and risk management around the deployment of AI.

Similarly, the UK ‘s sector focused principles-based approach, whilst flexible and allowing regulators to develop specific tools and guidance, risks regulatory overlaps, gaps and complexity, with guidance only really focusing on the implementation of the five regulatory principles of (i) safety, security & robustness; (ii) appropriate transparency and explainability; (iii) fairness; (iv) accountability and governance; and (v) contestability and redress.

In our discussion forum we therefore looked beyond legislative and regulatory compliance and considered key risk factors of AI deployment in life sciences organisations and the practical steps needed to manage those risks. Some key points from our discussion (primarily those related to life sciences R&D) are highlighted immediately below, but we will be covering other issues in greater detail, as well as providing practical next steps in future articles. Here are a few key points related to life science R&D:

  • In April EFPIA issued a statement setting out that it considers the scientific research and development exemption in the AI Act applies to AI-based drug development tools used in the research and development (R&D) of medicines. The statement received wide publicity and was welcomed by many, but it really misses the point, since there remain very considerable risks of using AI in medicines research, which require detailed consideration. These include questions of who owns the output of generative AI, an issue which is not straightforward to answer and depends on the jurisdiction (and legal position in the relevant jurisdiction), roles played by humans and terms and conditions of the relevant AI platform. If using AI to create or within R&D processes it may in fact be essential to ensure that AI is used only as a supplementary tool and is not contributing to invention conception in order to retain ownership of intellectual property (IP) rights.

 

  • Protection of confidential information is another significant area of concern. Terms and conditions of use of AI platforms may seek to prohibit IP protections and even allow the creator of the AI platform to use your data and confidential information to better improve their offerings. For this reason, it is important to review the terms and conditions of use and to implement contractual protections and safeguards with AI vendors to minimize the risk of disclosure and use of confidential company information. Some companies may be minded to go even further and restrict the use of generative AI altogether, given the difficulties of protecting data, IP and confidential information.

 

  • Ensuring the quality and relevance of data generated by AI is a challenge and rigorous testing and monitoring measures need to be implemented to guarantee data integrity. We envisage this will be an area where regulators may wish to become actively engaged to ensure medicines meet applicable standards for safety, quality and efficacy.

 

  • The EU is proposing to implement an AI liability Directive alongside the AI Act, which aims to modernise the current EU liability framework to make it easier for individuals to bring claims for harms caused by AI. Whilst companies will clearly need to implement measures to manage their AI liability risk, it is important to consider other potential liability risks associated with AI use, including IP infringement and breach of confidentiality. In the context of R&D for instance, it is worth remembering that large AI data models use considerable amounts of data from a wide number of sources. It is essential therefore for life sciences organisations to understand the origin of data used in large AI data models and ensure they get contractual assurances (and indemnities where appropriate) as to its origin and lawfulness of its collection/processing.

We have also been looking at some interesting questions affecting life science lawyers and compliance professionals and how they can best prepare themselves to address and manage legal and compliance risks arising from use of AI. Here are some interesting questions we posed in our discussion forum. What are your views?

  • Do lawyers need to become technical experts? How do we ensure lawyers/compliance professionals know enough about the potential risks of AI to be able to discuss key issues with staff?

 

  • The challenges of AI governance and risk management are considerable. What should the lawyer’s/compliance professional’s role be in the governance process? How is it possible to ensure that complex legal issues and legal risk are appropriately managed?

Next month we will be looking in detail at what the right approach to governance of AI risk should be, as one of our senior compliance professionals answers questions and provides her thought leadership on the issue.

We are continuously monitoring the developments in the governance of Artificial Intelligence, and what this means for our sector.  Please do not hesitate to contact us if you require any assistance in preparing for the implementation of the AI Act or developing and implementing AI governance and risk management procedures.