Blockchain and Clinical Trial (eBook)
VIII, 267 Seiten
Springer International Publishing (Verlag)
978-3-030-11289-9 (ISBN)
This book aims to highlight the gaps and the transparency issues in the clinical research and trials processes and how there is a lack of information flowing back to researchers and patients involved in those trials.
Lack of data transparency is an underlying theme within the clinical research world and causes issues of corruption, fraud, errors and a problem of reproducibility. Blockchain can prove to be a method to ensure a much more joined up and integrated approach to data sharing and improving patient outcomes. Surveys undertaken by creditable organisations in the healthcare industry are analysed in this book that show strong support for using blockchain technology regarding strengthening data security, interoperability and a range of beneficial use cases where mostly all respondents of the surveys believe blockchain will be important for the future of the healthcare industry.
Another aspect considered in the book is the coming surge of healthcare wearables using Internet of Things (IoT) and the prediction that the current capacity of centralised networks will not cope with the demands of data storage. The benefits are great for clinical research, but will add more pressure to the transparency of clinical trials and how this is managed unless a secure mechanism like, blockchain is used.
Prof. Hamid Jahankhani gained his PhD from the Queen Mary College, University of London. In 1999 he moved to the University of East London (UEL) to become the first Professor of Information Security and Cyber Criminology at the university in 2010. Over the last 15 years he has also been involved in developing new and innovative programmes and introducing 'block mode' delivery approach at UEL, including MSc Information Security and Computer Forensics, Professional Doctorate Information Security.
Jahankhani's principal research area for a number of years has been in the field of cyber security, information security and digital forensics. In partnership with the key industrial sectors, he has examined and established several innovative research projects that are of direct relevance to the needs of UK and European information security, digital forensics industries, Critical National Infrastructure and law enforcement agencies. He has planned, proposed and managed several collaborative projects, and secured a substantial research income of up to £6m. Professor Jahankhani is the Editor-in-Chief of the International Journal of Electronic Security and Digital Forensics, and International Journal of Electronic Democracy, both published by Inderscience, and general chair of the annual International Conference on Global Security, Safety and Sustainability (ICGS3). Hamid has edited and contributed to over 15 books and has over 150 conference and journal publications together with Various BBC radio interviews. Jahankhani has supervised to completion 13 PhD and professional doctorate degree students and overseen 67 PhD students progressing. In summer 2017 Hamid was trained as the GCHQ 'cyberist' to train the next generation of cyber security experts through GCHQ CyberFirst initiative.As part of his research in partnership with the key industrial sectors, Jahankhani has examined and established several innovative research projects that are of direct relevance to the needs of UK and European information security, digital forensics industries and law enforcement agencies.
Most of his work in the field has been manifested in a number of ways so that it contributes significantly to the measures governments must take to protect the security of information on the Internet, the implications of cyber-crime in large corporations and individuals, threat Assessment, risk analysis and the formulation of security policies, vulnerability Assessment.
Jahankhani has been leading International and National research projects in a number of areas. Together with his research team and collaborators from Kaspersky Lab and Plymouth university he developed useful profiles of cyber criminals. In the case of cybercrime as there is a rapid change of the technology, therefore, cyber criminal's behaviour may become dynamic. This change in behaviour will require a reclassification of the typology being currently used. Essentially, cyber criminal's behaviour is evolving and changing overtime with experience where they learn from their actions, or from their friend's experience, which will enhance their skills. The offender signature which is a repetitive ritualistic behaviour that the offender usually displays at every crime scene provides police an appropriate profiling tool. This will give the investigator the opportunity to understand the motivations that drives the offender to perpetrate such crime. This development has resulted in assisting the researcher in the classifying of the type of perpetrator that is being sought.His longstanding and international recognized work in his field of research has generated esteem indicators such as;
- Setting up and editorship of the International Journal of Electronic Security and Digital Forensic
The International Journal of Electronic Security and Digital Forensic, IJESDF is first of its kind to cover the two interlinked field/ topics of electronic security and digital forensic investigation, www.inderscience.com/ijesdf.
- Handbook on Electronic Security and Digital Forensics
- Annual international conference on global security safety and sustainability, ICGS3
Stefan Kendzierskyj is an experienced commercial director gained in a number of leading edge technology companies, covering most industry sectors. Usually presenting at Board level, looking at strategic approaches for businesses to undertake digital transformation and to find innovative ways to reach new markets. Over recent years this has been in the form of collaborating with some high profile Publishers and large Associations that need to reach a global audience with their vision and messaging, particularly in the healthcare and corporate sector. He also provides publisher services for the UK Disaster Victim Identification team and Interpol in the form of process tools to aid in the investigation work for mass fatalities.
Stefan holds an MSc in Cyber Security, attaining Distinction level and has published a number of articles and books concerning blockchain and clinical trials, critical national infrastructure, security/privacy of data and in the process of other related publishing works and also a speaker at cyber security events and conferences.
Foreword 6
Contents 7
Chapter 1: Blockchain and Healthcare 9
1.1 Introduction to Blockchain Technology: Features and Application in Healthcare 9
1.2 Overview of Blockchain Types and Consensus Mechanisms 13
1.3 Blockchain Security Risks and Opportunities: Identifying the Threat Landscape 18
1.4 Benefits and Challenges of Blockchain Technology in Healthcare Sector 21
1.5 Blockchain Healthcare Platform Examples 27
1.6 Blockchain Healthcare Pilots and Initiatives 31
1.7 Summary 33
References 35
Chapter 2: Digital Transformation of Healthcare 38
2.1 Introduction 38
2.2 Defining the Driving Factors of Blockchain in Healthcare 39
2.3 Digital Transformation of Healthcare Records 42
2.4 Privacy of Data and Interoperability 44
2.4.1 Interoperability 45
2.5 Pushing the Barriers of EHR Access 47
2.6 Smart Wearables and Data Capture 47
2.7 Patient Centric Data Ownership 50
2.8 Other Blockchain Health Transformation Benefits 51
2.8.1 Claims Adjudication 51
2.8.2 Drug Traceability and Issues in the Supply Chain 52
2.9 Is the Healthcare Industry Ready for Blockchain? 52
2.10 Conclusions 57
References 58
Chapter 3: Healthcare Patient and Clinical Research 60
3.1 Introduction 61
3.2 Transparency of Clinical Research/Trials and Drug Traceability 61
3.3 Theoretical Model Using Blockchain to Secure Data in Clinical Research Trials 62
3.4 Using Blockchain for Tackling the Issues 64
3.5 Clinical Trials & Research Phases
3.5.1 Clinical Trial Phases 66
3.5.1.1 Clinical Phase Stages 66
3.5.1.2 Design Considerations of a Trial 67
3.5.1.3 Description of Process in the Phases 68
3.6 Smart Wearable Health Devices in Clinical Trials 70
3.7 Publication and Post Marketing Effects and Issues 71
3.8 Regulation/Non-regulation and Pharmaceutical Behaviours 71
3.9 Drug Manufacturers and Suppliers 72
3.10 Patients and Clinical Researchers 73
3.11 Clinical Trials Processes 73
3.12 Clinical Registration Analysis 74
3.13 Informed Consent and Privacy 75
3.14 Clinical Outcomes Data Analysis 76
3.15 Global Aspect of Clinical Trials 77
3.16 Clinical Outcomes Data Concerns 77
3.17 Research Misconduct, Fraud and Selective Reporting Impacts 80
3.17.1 Types of Fraud and Misconduct in Clinical Research 83
3.17.2 Publishing Clinical Trial Data – Noncompliance 85
3.18 Cyber Risks to Clinical Healthcare Data 86
3.19 Case Studies: Marketing Ineffective/Dangerous Drugs – Opioids Study, Breast Cancer Screening – Interoperability Study, etc 90
3.19.1 Opioids Misuse 90
3.19.2 Breast Cancer Screening – Interoperability Study 92
3.20 Conclusions 93
References 93
Chapter 4: Information Security Governance, Technology, Processes and People: Compliance and Organisational Readiness 96
4.1 Introduction 97
4.2 Compliance Standards in Healthcare 99
4.3 Maturity Assessments: Wargaming and Threat Intelligence Sharing to Improve Sectoral Cyber Resilience 100
4.4 Process Focus 104
4.5 People 106
4.5.1 Onboarding, Identity and Access Management 106
4.5.2 User Awareness Training 107
4.5.2.1 Leadership and C-Suite 108
4.6 Incident Response Team Readiness Exercises -Red Teaming. From Compliance to Readiness 111
4.7 How Our Private Digital Exposure Can Permeate Corporate Systems 114
4.7.1 Why System 1 and 2 Thinking Are Fundamental When Increasing Security Awareness 115
4.7.2 Team Dynamics in Cybersecurity 116
4.7.3 Human Vulnerabilities 117
References 119
Chapter 5: Cyber-Physical Attacks and the Value of Healthcare Data: Facing an Era of Cyber Extortion and Organised Crime 121
5.1 Introduction 122
5.2 Electronic Health Records and Their Value to the Black Market: A Rare Commodity to the Organised Cyber Crime 124
5.3 Electronic Health Records for Clinical Trials and Research 132
5.4 Crypto-Viral Extortion Attacks and Its Impact on Healthcare 133
5.5 Analysis of Blockchain Technologies, the Onion Router, and Other Tools Used for Anonymity During the Execution of a Cyber Attack 135
5.6 Conclusion and Further Research 141
References 142
Chapter 6: The Transparency of Big Data, Data Harvesting and Digital Twins 144
6.1 Introduction 145
6.2 Big Data and Healthcare Impact 146
6.2.1 Data Harvesting and Mining 147
6.2.2 Social Media Data Misuse 148
6.3 Digital Twins in Healthcare: Transparency, Ethical Implications and Security Concerns 149
6.4 Conclusions 152
References 152
Chapter 7: Blockchain for Modern Digital Forensics: The Chain-of-Custody as a Distributed Ledger 154
7.1 Introduction 155
7.2 Why Police Digital Investigators Need to Understand Blockchain Technology 157
7.2.1 To Maintain Compliance with Digital Investigation Principles 157
7.2.2 To Facilitate Multijurisdictional Investigations 158
7.2.3 To Have More Witnesses 158
7.2.4 To Support Victims with Blockchain-Based Forensic-Enabled Devices 159
7.2.5 To Investigate Technology Misuse 159
7.2.6 To Develop New Solutions in Response to Emerging Digital Forensics Challenges 159
7.3 How Blockchain Technology Can Improve the Deployment of Digital Investigation Models 160
7.3.1 Introducing Digital Investigation Models 160
7.3.2 Integrating Blockchain Technology for Digital Investigation Models 161
7.4 Towards a Blockchain-Based Digital Forensic Chain-of-Custody 164
7.5 Blockchain for Forensic-Enabled Electronic Systems: A Case Study in eHealth 167
7.6 Blockchain to Enable Digital Witnesses 169
7.6.1 Exploiting the Widespread of IoT Devices 169
7.6.2 The Role of a Witness 169
7.6.3 IoT Devices as Digital Witnesses 170
7.7 Conclusions 172
References 172
Chapter 8: The Standardised Digital Forensic Investigation Process Model (SDFIPM) 174
8.1 Introduction 175
8.1.1 Research Problem and Contributions 176
8.1.2 Authors’ Note 177
8.1.3 Structure of the Chapter 178
8.2 Literature Review 178
8.3 Overview of the Investigative Process Model 185
8.3.1 Examination Process 186
8.3.1.1 Survey Digital Crime Scene 186
8.3.1.2 Examine Acquired Data 188
8.3.1.3 Harvest Data 188
8.3.1.4 Reduce Data 189
8.3.1.5 Identify, Classify and Organise Digital Evidence 189
8.3.2 Analysis Process 190
8.3.2.1 Develop a Hypothesis 190
8.3.2.2 Analyse Digital Evidence 191
8.3.2.3 Attribute 191
8.3.2.4 Evaluate Analysis Results 191
8.3.3 Interpretation Process 192
8.3.3.1 Interpret Analysis Results 192
8.3.3.2 Classify and Organise the Interpreted Evidence 193
8.3.4 Event Reconstruction Process 193
8.3.4.1 Event Reconstruction Components 194
8.3.5 Reporting Process 195
8.3.6 Presentation Process 196
8.3.6.1 Components of the Presentation Process 198
8.3.7 Investigation Closure Process 199
8.3.7.1 Review the Outcome of the Case 199
8.3.7.2 Accept or Reject the Hypothesis 200
8.3.7.3 Conduct a Critical Review 200
8.3.7.4 Evidence Management 201
8.3.7.5 Record the Case Decision 201
8.3.7.6 Disseminate the Investigation Results 202
8.3.8 Overriding Principles 202
8.3.8.1 Preserve Digital and Physical Evidence 203
8.3.8.2 Preserve Chain of Custody 204
8.3.8.3 Manage Information Flow 206
8.3.8.4 Maintain a Detailed Case Management 206
8.3.8.5 Prepare and Test Tools and Techniques 208
8.3.8.6 Obtain and Adhere to Authorisation 209
8.3.8.7 Maintain a Detailed Documentation 209
8.3.8.8 Interact with Physical Investigation 210
8.4 Conclusion 210
References 211
Chapter 9: Hybrid Cyber Security Framework for the Internet of Medical Things 215
9.1 Introduction 216
9.1.1 IoMTs Threat Landscape 216
9.2 Attack Taxonomy 216
9.2.1 Information Based Attacks 217
9.2.2 Host Based Attacks 217
9.2.3 Network Based Attacks 218
9.3 IoMTs Privacy and Security Classification 218
9.3.1 IoMTs Architecture and Attack Classification 218
9.4 Attack Classification and Mitigation 219
9.4.1 Perception Layer 219
9.4.2 Network Layer 220
9.5 The Importance of Cyber Security in IoMTs 220
9.5.1 Privacy 221
9.5.2 Patient Safety 221
9.5.3 IoMTs Impact and Risk 222
9.6 Cyber Security Best Practice Frameworks 223
9.6.1 Review of Cyber Security Best Practice Frameworks 224
9.6.2 IoMTs Best Practice and Principles 224
9.6.3 Blockchain for IoMT Security 225
9.6.4 IoMT and Big Data: The Impact of IoMT on Clinical Trials 225
9.6.5 Hybrid Cyber Security Framework (HCSF) 226
9.6.6 Operational and Technical Controls 227
9.6.6.1 Stakeholders 228
9.6.6.2 Processes 228
9.6.7 IoT Environment 230
9.6.8 International Standards and Best Practice 231
9.7 Conclusions 231
References 231
Chapter 10: BMAR – Blockchain for Medication Administration Records 234
10.1 Introduction 234
10.2 Design 235
10.2.1 Data Protection 237
10.2.2 Prescription 238
10.2.3 Management 239
10.2.3.1 Assign Key Worker 239
10.2.3.2 Register Service-User with Home 240
10.2.4 Medical Administration 241
10.2.5 Medical Observation 241
10.2.6 Audit and Security 242
10.3 Results 243
10.3.1 Prescription 243
10.3.2 Medical Administration 244
10.3.3 Observation 245
10.4 Management 246
10.4.1 Audit 246
10.5 Conclusions 247
References 250
Chapter 11: Recent Cyber Attacks and Vulnerabilities in Medical Devices and Healthcare Institutions 252
11.1 Introduction 252
11.2 Medical Implants: Data Transmission 253
11.2.1 Radio Frequency (RF) Technology 254
11.2.2 Electromagnetic Interference (EMI) 254
11.2.3 Radio Frequency Identification (RFID) 255
11.3 Pacemakers and ICDs Background Knowledge 256
11.3.1 Operational Functions of a Pacemaker 256
11.3.2 Implantable Cardioverter Defibrillator (ICD) 256
11.3.3 Home Monitoring Units 257
11.3.4 RF Implants 257
11.3.5 Bluetooth Implants 258
11.4 Industrial Practices 258
11.4.1 Legal Cases 259
11.4.2 Encryption and Software 259
11.4.3 Vulnerabilities in Pacemakers 260
11.4.4 Vulnerabilities in Medical Equipment 261
11.4.5 Cyber-Attack Trends to Healthcare Section 263
11.5 IoMT and Its Future Security 268
References 268
| Erscheint lt. Verlag | 8.4.2019 |
|---|---|
| Reihe/Serie | Advanced Sciences and Technologies for Security Applications | Advanced Sciences and Technologies for Security Applications |
| Zusatzinfo | VIII, 267 p. 84 illus., 73 illus. in color. |
| Sprache | englisch |
| Themenwelt | Mathematik / Informatik ► Informatik ► Web / Internet |
| Medizin / Pharmazie | |
| Technik ► Bauwesen | |
| Schlagworte | Blockchain Technology in Healthcare • Clinical Research Data • Clinical Trials Data Flow • electronic healthcare • General Data Protection Regulation • healthcare data • Healthcare Online • Internet of Things in clinical trials • patient privacy • Transparency of clinical trials |
| ISBN-10 | 3-030-11289-6 / 3030112896 |
| ISBN-13 | 978-3-030-11289-9 / 9783030112899 |
| Haben Sie eine Frage zum Produkt? |
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