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Digital Risk: Life Sciences & Health Care

Creating confidence at the edge of possibility

How is digitisation impacting the Life Sciences & Health Care sector?

The race for competitive edge has never been fiercer, innovation and resilience never more essential to success. Pursuing advantage means boldly acknowledging risk and going confidently forward - leaning into new possibilities undaunted by scale or complexity. Leading organisations know that people, processes and technology combine to continually reshape the frontiers of possibility – from the adoption of cloud, the shift to remote working, automation and artificial intelligence.

We can create the confidence to marshal these possibilities to action and help the leaders driving digital transformation create sustainable value.

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Responding to the risks that digital brings

Thriving in the new normal requires adapting to new technologies to stay competitively relevant while mitigating the risks to the business.

Safe and ethical implementation of artificial intelligence and machine learning
Create the confidence and understanding to successfully embrace radical and dynamic new decision support systems in order to explore new frontiers in value creation		   Risk conduct, regulation and culture in the digital world
Lean into the possibilities of digital while confidently controlling the risks created by having a closer relationships with the consumer
Transforming digitally with confidence
Step forward into possibility, while being prepared for the unknown		   Controlling disruptive technologies, cloud, data and agile ecosystems
Create positive change through controlled revolution; protect BAU activity whilst embracing disruption
Digitisation of risk, compliance and control management
Transform effectively and safely by embracing digital strategies for managing digital risks		  

Consider: How do these digital risks impact you?

Organisations should build the digital confidence required to thrive in the “digital world”

Board
Are we getting the right level of information about the digital change happening in the business? 		  CIO
How can I confidently embrace new technologies and mitigate the risks of digital to allow for a more confident and effective business?
CMO
Am I able to harness the technologies and innovations that get the business closer to the customer and set us apart from the competition?		   CTO
How can I build the trust in digital that’s necessary to overcome transformation fears and realise transformation success?
CISO
How can I help the business embrace digital, build safe and secure solutions by embedding risk management and security throughout the innovation and development cycle?		      

Life Sciences & Health Care: 2021 Digital Risk trends

Shift to Digital & Personalised

Trends

Services are accessible anytime, anywhere, as well as the rise of highly-personalised patient care through sensors and digital services and the ‘connected patient’

Risks

  • Failure to adopt and adapt quickly enough
  • Fundamental sector shift risking efficiency and buy-in
  • Generalising the patient demand and experience 
  • Risk of reliance on digital ecosystem to patient safety and data

Questions

  • Transformation: Do you have a strategy, budget and reach planned? How is this determined? How is success measured?
  • Ecosystem: How will you structure and govern virtual and digital care in order to optimise processes?
  • Customers: Are your patient journeys inclusive? Do you know your patient needs, and how to interact?
  • Compliance: How will your approach impact Healthcare Practitioner engagement and compliance requirements? 

Telemedicine

Trends

Controlling and distributing the patient experience digitally saves time and money, and enables increased accessibility between patients and physicians

Risks

  • Risk to patient safety and data in a digital landscape
  • Failure to adopt a forward-looking and evolutionary mind-set towards technology and process optimisation, resulting in loss of market competitiveness
  • Failure to embrace a culture of connectivity and collaboration digitally
  • Missed returns from digital transformation due to limited adoption

Questions

  • Safety: How will you ensure a high standard of virtual care and monitor this? How will you protect patient safety and data? How will you protect sensitive patient information from risk of exposure?
  • Buy-in: How to drive a fundamental mind-set change through digital transformation? How will you make data accessible and understandable to individuals as required? How do you maximise technology adoption and minimise cultural resistance? How do you deliver your business ethics and practices to customers, the organisation and business community? 
  • Support: How do you support employees and customers in new environment?
  • Competitiveness: How do you balance change, consistency and security? 

AI in GxP environment

Trends

Artificial Intelligence and ML has the potential to transform operations in the medical devices and pharmaceutical manufacturing industries by improving treatment outcomes and increasing efficiencies and quality. Despite its tremendous potential, currently it lacks adoption in the product critical areas like GxP due to the ultimate risks to patient safety, data integrity and product quality

Risks

  • Limited transparency, explainability and reproducibility of results means control, reliability and traceability may be difficult to implement
  • Quality of output data depends on the data that AI was trained on. E.g. incorrect, limited or not reflective of real life
  • Lack of regulatory requirements for validating AI / ML systems and no industry-wide accepted concepts for AI quality assurance
  • Failure to demonstrate Governance and Accountability for internal policies and decision-making where AI technologies automates many decisions.

Questions

  • Data Integrity: How do you ensure the appropriateness of Data Integrity through AI ?
  • Testing: How do you Validate the code of Application ?
  • Cost: How do you manage the cost as validating an AI based system may be more expensive?
  • Governance: How do you achieve AI governance?
  • Audit Trail: How do you ensure Audit Trail functionality is appropriate through AI?

Scaling Artificial Intelligence & New Technology

Trends

Automation and robotics are being scaled to run procedures, diagnoses and interactions independently or semi-autonomously, optimising performance and productivity through leveraging patient data

Risks

  • High costs of implementation (human and monetary)
  • Cyber, human and service risks posed via data/patient access
  • Risk of automating processes using robots and the impact on patient safety
  • Risk of making complex decisions depending upon patient data and calculations
  • Productivity loss through automation malfunction and/or lost knowledge, feeding through to product recipients

Questions

  • Strategy: What is your budget, reach, and plan for new technology? Which processes could be optimised?
  • Security: How do you protect the personal data new technology oversees? How do you manage, track & respond to cyber, human and service risk?
  • Robotics: How will you govern and monitor RPA to deliver improved LSHC services? Where does accountability lie?
  • Governance: What is the governance process for new technology? How do you track performance and monitor outcomes? What controls are in place around technology-enabled solutions? Would your current governance controls pick up new technology as a thing to be managed?
  • Data: How will you configure new technology? What’s the backup plan? How will you manage and ensure compliance?

Migrating to the cloud

Trends

Companies are adopting a cloud-first strategy and migrating legacy systems to the cloud, improving business operations, security and consistency

Risks

  • Costs of implementation and upkeep
  • Cyber risk of systems being managed online and the damage that could be posed by any breach
  • Data risk and loss through migration and storage
  • Lack of cloud strategy and migration plan
  • Limited data and infrastructure visibility, control and security 

Questions

  • Security: How do you manage access and protect against risk currently? How will you adjust this infrastructure in the cloud?
  • Data: What is your current architecture? How scalable / flexible is your landscape? How do you secure & protect against data loss?
  • Governance: How will you encourage organisation buy-in? Can you control the speed and extent of your Cloud transformation? Where does responsibility end?
  • Control: How do you secure data and ensure regulatory compliance? Do you have oversight of your global landscape (costs/digital)?

Supply Chain Resilience

Trends

As organisations adapt and adopt increasingly digitised ways of working, supply chain continuity, resilience and disaster recovery require new and prioritised thinking to enhance and protect operations and patients

Risks

  • Failure to successfully and securely integrate third parties and patients into supply chain
  • Limited cyber risk awareness and defences
  • Limited customer understanding/use of benefits
  • Compromising of data privacy and confidentiality
  • Failure to realise value from and benefits of investments

Questions

  • Supply chain: How in control are you? What is your supplier risk profile?
  • Security: How do you track and ensure security? Do you implement constant monitoring and alerts for security and compliance requirements?
  • Privacy: Do you implement it from the beginning, into all systems and operations? How will you ensure supplier and patient buy-in?
  • Data: How connected, accessible and transparent is your data? Do you run analytics to optimise performance?
  • Tools & Technology: Is your technology investment achieving measurable outcomes for your stakeholders?

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