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Centre for Law, Medicine and Life Sciences

Faculty of Law
 

Aboy

Prof. Mateo Aboy

PhD/SJD Law, PhD ECE, CEng, Fellow (FIT IAPP), CIPP/E, CIPM, MBA, CLP, MPhil, MS ECE,
BSEE (Hons), BS (Hons)

Principal Research Scholar in Biomedical Innovation, Precision Medicine, AI & Law
Centre for Law, Medicine and Life Sciences (LML)

Visiting Scholar in Precision Medicine, AI & Law (PMAIL), PTF, Harvard University
Affiliated Professor & Fellow, CeBIL, University of Copenhagen
Professor, EERE, ETM, OIT

Fellow (FIT), International Association of Privacy Professionals (IAPP)
Email: ma608[at]cam.ac.uk (U. Cambridge) | Personal Site
 

Overview & Research

Prof. Mateo Aboy joined the LML in 2015. His research includes evidence-based IP studies of precision medicine and information age inventions (biomarkers, diagnostics, and AI/algorithm-based inventions), medical device regulation (AI/ML SaMD), COA/biomarker qualification, information security, and privacy/data protection law. 

Mateo pursues research at the interface between engineering, law, and management sciences. He is currently researching the status of precision medicine inventions as patentable subject matter. A core component of this work is an in-depth quantitative analysis of trends in patenting activity and patent examination following key United States Supreme Court decisions affecting biomedical, biotech, and computer-implemented inventions (Myriad, Mayo, Alice), coupled with a comparative study of European patent law. This work sheds light on the implications of legal doctrine for prosecution strategies, licensing and innovation. Additionally, he pursues research on AI/ML SaMDs, medical device law, regulatory science, biomarker qualification, and data privacy law. 

 

Interests

Computational Data Science (Big Data); Biomedical Signal Processing; Medical Device Development; Biomarker Development & Qualification; Intellectual Property; Patent Law; Patent Valuation & Licensing; Medical Device Law; SaMDs; IP Informatics & Analytics; Patent Landscaping & Patent Search Algorithm Development; Patentability of Information Age Inventions; Technology-based Innovation; Empirical Legal Research; IP Strategy & Management; Information Law: Privacy Law; Information Security; QMS/ISMS/PIMS; GxP (cGMP, cGCP).
 

Brief Bio

Mateo’s multidisciplinary background includes a combination of intellectual property, engineering, regulatory science, and management experience. He holds degrees in electrical & computer engineering (BS, BSEE, MSECE, MPhil/DEA, PhD ECE), law (SJD/PhD/LLD), and international management (MBA), as well as professional registrations as a Professional Chartered Engineer (EU/ES COIT), Certified Licensing Professional (CLP), Patent Practitioner with a Bar Admission/licensed to practice in patent cases before the United States Patent Office (USPTO), Fellow of Information Privacy (FIT, IAPP), Certified Privacy Information Professional (CIPP/E), Certified Privacy Manager (CIPM), Lead Implementer of Information Security Management Systems-ISMS (ISO 27001), Lead Auditor of Medical Device Quality Management Systems (ISO 13485), Lead Implementer of Privacy Information Management Systems - PIMS (ISO 27701), and Certified Data Protection Officer (C-DPO). 

He is author of more than 150 scholarly articles published in leading scientific, engineering and legal journals, including Nature Biotechnology, IEEE Transactions of Biomedical Engineering, Medical and Biological Engineering & Computing, Medical Engineering & Physics, Journal of Law & the Biosciences, and Journal of Intellectual Property Law & Practice.   

His professional experience includes work in various senior roles both in private sector and in academia. As a Licensed Patent Practitioner, he has successfully prosecuted numerous cases before the USPTO, focusing primarily on medical device and computer-implemented inventions. He holds over 20 patents as an inventor and is the co-founder of APDM Wearable Technologies, Inc (a medical device & clinical trial services company acquired by ERT, Inc on June 9th, 2020 to launch ERT’s Wearables and Digital Biomarker product line of clinical trial solutions).

Mateo has taught university courses in engineering (computational data science; scientific & engineering computation; digital signal processing; electronics; programming; research methods & innovation), law (IP law, patent law; business law), and management (strategy, innovation, and entrepreneurship; engineering management). He is currently a Principal Research Scholar at the LML Centre (University of Cambridge), an affiliated Professor & Fellow at the CeBIL Centre (University of Copenhagen), and a Visiting Scholar at the Petrie-Flom Center (Harvard University). 

 

Research & Consulting

Prof. Aboy pursues research at the interface between engineering, law, and management sciences. He also consults through Cambridge University Technical Services (CUTS) This includes research and consulting in the following areas:

  • Intellectual Property Law: Patent Law
  • Information Law: Privacy Law & Data Protection
  • Regulatory Science (Medical Device & Pharmaceutical)
  • Medical Device Regulation (FDA 510k, De Novo, PMA, CE Medical)
  • Software as Medical Devices (SaMDs)
  • COA/Biomarker Qualification (FDA/EMA COA/Biomarker Qualification Programs)
  • Computational Data Science & IP
  • IP Informatics & Computational Analytics
  • Automated Patent Search Algorithm Development
  • Patent Landscape Studies
  • Empirical Legal Research (Impact Empirical Analysis of IP Decisions)
  • Digital Signal Processing (DSP), Biomedical Signal Processing (BSP)
  • AI/Machine Learning & IP
  • Precision Medicine & IP (Biomarkers, Diagnostics, Algorithms)
  • Patentability of Computer-Implemented & Biotech Inventions
  • Patent Valuation, Licensing & Technology Transfer
  • Intellectual Capital & IP Strategy & Management
  • Technology & Innovation Management: Competitive Strategy & Disruptive Innovation
  • ISMS - Information Security Management Systems (ISO 27001)
  • PIMS - Privacy Information Management Systems (ISO 27701)
  • QMS - Medical Device Quality Management Systems (ISO 13485, FDA QSR)
  • MDSAP - Medical Device Single Audit Program 
  • GxP: cGMP (Medical Devices); cGCP (Computer Systems & Clinical Data Management Systems)
  • Cross-Border Transfers of Clinical Trials Data (GDPR & CTR)
  • Cross-Border Transfers of Cloud-Based Digital Health Wearable Device Data 

   

Selected Publications 

Prof. Aboy's peer-reviewed article publications include:

  •  Standard contractual clauses for cross-border transfers of health data after Schrems II Journal of Law and the Biosciences 8(1), 2021
  •  The Patentability of Computer-Implemented Simulations and Implications for Computer-Implemented Inventions (CIIs) Journal of Intellectual Property Law & Practice, 2021
  • The FDA De Novo medical device pathway, patents and anticompetition JS Sherkow, M Aboy Nature Biotechnology 38 (9), 1028-1029 (2020)
  • International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection L Bradford, M Aboy, K Liddell Journal of Law and the Biosciences (2020)
  • COVID-19 Contact Tracing Apps: A Stress Test for Privacy, the GDPR and Data Protection Regimes LR Bradford, M Aboy, K Liddell Journal of Law and the Biosciences (2020)
  • Reply to CD Richter J Liddicoat, K Liddell, AH McCarthy, S Hogarth, M Aboy, D Nicol, S Patton, ... European Journal of Human Genetics 28 (5), 537-538 (2020)
  • One year after Vanda, are diagnostics patents transforming into methods of treatment to overcome Mayo-based rejections? M Aboy, C Crespo, K Liddell, N Davey, J Liddicoat, T Minssen Nature Biotechnology 38 (3), 279-283 (2020)
  • Lost on the High Seas without a Safe Harbor or a Shield? Navigating Cross-Border Data Transfers in the Pharmaceutical Sector After Schrems II Invalidation of the EU-US Privacy … M Corrales Compagnucci, T Minssen, C Seitz, M Aboy European Pharmaceutical Law Review 4 (3), 153-160 (2020)
  • Lost on the High Seas without a Safe Harbor or a Shield? Navigating Cross-Border Transfers in the Pharmaceutical Sector After Schrems II Invalidation of the EU-US Privacy Shield MC Compagnucci, T Minssen, C Seitz, M Aboy European Pharmaceutical Law Review 4 (3), 153-160 (2020)
  • Regulatory responses to medical machine learning T Minssen, S Gerke, M Aboy, N Price, G Cohen Journal of Law and the Biosciences (2020)
  • The EU-US Privacy Shield Regime for Cross-Border Transfers of Personal Data under the GDPR C Seitz, T Minssen, M Aboy, M Corrales Compagnucci European Pharmaceutical Law Review 1 (1), 1-17 (2020)
  • The EU-US Privacy Shield Regime for Cross-Border Transfers of Personal Data under the GDPR: What Are the Legal Challenges and How Might These Affect Cloud-Based Technologies … T Minssen, C Seitz, M Aboy, MC Compagnucci EPLR 4, 34 (2020)
  • "How does emerging patent case law in the US and Europe affect precision medicine?" Nature Biotechnology 37 (10), 1118-1125 + SI (2019)
  • Mayo’s impact on patent applications related to biotechnology, diagnostics and personalized medicine M Aboy, C Crespo, K Liddell, T Minssen, J Liddicoat
    Nature biotechnology 37 (5), 513-518 + Supplementary Info (2019)
  • Was the Myriad decision a 'surgical strike' on isolated DNA patents, or does it have wider impacts? M Aboy, C Crespo, K Liddell, J Liddicoat, M Jordan, Nature Biotechnology 36 (12), 1146-1150 + SI (2018)
  • After Myriad, what makes a gene patent claim 'markedly different' from nature? M Aboy, J Liddicoat, K Liddell, M Jordan, C Crespo,Nature biotechnology 35 (9), 820-825 + SI (2017)
  • Myriad’s Impact on Gene Patents. Aboy M, Liddell K, Liddicoat J, Crespo C, Nature Biotechnology, 2016, Vol 34 Number 11 Pages: 1119-1123 +SI (2016)
  • Inertial and Time-of-Arrival Ranging Sensor Fusion. P Vasilyev, S Pearson, M El-Gohary, M Aboy, Gait & Posture, 2017, 54, 1-7
  • Review of Recent Patents in the Area of Intelligent, Adaptive, Wireless & GPS Enabled Control Devices, Polk E, Polk L, Aboy M, Crespo C, Recent Patents in Engineering, 2016, 10(3), 175-186
  • Review of Recent Patents on Carbon Nanotube Based Electrodes for Use in Supercapacitor Applications. Diaz C, Ponder AR, McGee M, Crespo C, Aboy M, Recent Patents on Engineering, 2015, 9 (1) Pages: 21-28 
  • Review of Recent Patents on Detection and Quantification of Tremor. Aboy M, Crespo C, McNames J, Sprunger J, Recent Patents on Biomedical Engineering, 2013, 6 (2) Pages: 89-96
  • Review of Recent Patents on Wearable Movement Sensors. Aboy M, McNames J, Crespo C, Recent Patents on Biomedical Engineering, 2013, 6 (2) Pages: 82-88 
  • Clinical Application of a Novel Automatic Algorithm for Actigraphy-Based Activity and Rest Period Identification to Accurately Determine Awake and Asleep Ambulatory Blood Pressure Parameters and Cardiovascular Risk. Crespo C, Fernandez J, Aboy M, Mojon A, Chronobiology International: The Journal of Biological and Medical Rhythm Research, 2013, Vol 1-2 Page(s): 43-54 
  • Pulse Pressure Variation Tracking Using Sequential Monte Carlo Methods Biomedical Signal Processing and Control. Sunghan K, Aboy M, McNames J, Biomedical Signal Processing and Control, 2013, Vol 8 Page(s): 333-340 
  • Influence of QRS Complexity Detection Error on Entropy Measures. Molina-Pic A, Cuesta-Frau D, Mir-Martnez P, Oltra-Crespo S, Aboy M, Medical & Biological Engineering and Computing, 2013, Vol 110(1) Page(s): 2-11 
  • Automatic Identification of Activity-Rest Periods Based on Actigraphy. Crespo C, Aboy M, Fernandez JR, Mojon A. Medical & Biological Engineering and Computing, 2012, Apr; 50(4) Page(s): 329–340 
  • Automated Prediction of the Apnea-Hypopnea Index from Nocturnal Oximetry Recordings. Marcos JV, Hornero R, Alvarez D, Aboy M, Del Campo F, IEEE Transactions on Biomedical Engineering, 2012; Jan; 59(1)) Page(s): 141-149  
  • Pulse Pressure Variation: Where Are We Today? Cannesson M, Aboy M, Hofer C, Rehman M.
    Journal of Clinical Monitoring and Computing, 2011, Feb; 25(1) Page(s): 45-46
  • An enhanced automatic algorithm for estimation of respiratory variations in arterial pulse pressure during regions of abrupt hemodynamic changes. Aboy M, Crespo C, Austin D.
    IEEE Transactions on Biomedical Engineering, Volume: 56, 2009, Page(s): 2537-2545
  • Statistical modeling of cardiovascular signals and parameter estimation based on the extended Kalman filter. McNames, J.; Aboy, M. IEEE Transactions on Biomedical Engineering, Volume: 55, Issue: 1, 2008, Page(s): 119-129
  • Design and implementation of a portable physiologic data acquisition system Vinecore, K.; Aboy, M.; McNames, J.; Phillips, C.; Goldstein, B. Pediatric Critical Care Medicine, Volume: 8, Issue: 6, 2007, Page(s): 563-569
  • Pulse Morphology Visualization and Analysis with Applications in Cardiovascular Pressure Signals. Ellis, T.; McNames, J.; Aboy, M. IEEE Transactions on Biomedical Engineering, Volume: 54, Issue: 9, 2007, Page(s): 1552-1559
  • Reliability and Accuracy of Heart Rate Variability Metrics versus ECG Segment Duration. McNames; Aboy, M Medical & Biological Engineering and Computing, Volume: 44, Issue: 9, 2006, Page(s): 747-756
  • Interpretation of the Lempel-Ziv complexity measure in the context of biomedical signal analysis. Aboy M, Hornero R, Abasolo D, Alvarez D, IEEE Transactions on Biomedical Engineering, Volume: 53, Issue: 11, 2006, Page(s): 2282-228
  • The Population RDH Index. A Novel Index and Graphical Method for Statistical Assessment of Antihypertensive Treatment Reduction Duration, and Homogeneity. Aboy, M.; Fernandez, J.R.; Hermina, R.C. Blood Pressure Monitoring. Volume: 11, Issue: 3, 2006, Page(s): 143-155
  • The Individual RDH Index. A Novel Vector Index for Statistical Assessment of Antihypertensive Treatment Reduction, Duration, and Homogeneity. Aboy, M.; Fernandez, J.R.; Hermina, R.C. Blood Pressure Monitoring. Volume: 11, Issue: 2, 2006, Page(s): 69-78
  • An Automatic Beat Detection Algorithm for Pressure Signals. Aboy, M.; McNames. J; Thong, T.; Tsunami, D.; Ellenby, M. Goldstein, B. IEEE Transactions on Biomedical Engineering, Volume: 52, Issue: 10, 2005 Page(s): 1662-1670
  • Interpretation of Approximate Entropy. Case Studies in the Analysis of Intracranial Pressure During Acute Elevations in Traumatic Brain Injury. Honero, R.; Aboy, M.; Absalo, D.; McNames, J.; Goldstein, B. IEEE Transactions on Biomedical Engineering, Volume: 52, Issue: 10 , 2005, Page(s): 1671-1680
  • Adaptive Modeling and Spectral Estimation of Nonstationary Biomedical Signals Based on Kalman Filtering. Aboy, M.; Mrquez, O.W.; McNames, J.; Hornero, R.; Thong, T.; Goldstein, B. IEEE Transactions on Biomedical Engineering, Volume: 52, Issue: 8, 2005, Page(s): 1485-1489
  • Methodological Considerations in the Evaluation of the Duration of Action of Antihypertensive Therapy Using Ambulatory Blood Pressure Monitoring. Aboy, M.; Fernandez, J.R.; Hermina, R.C. Blood Pressure Monitoring. Volume: 10, Issue: 3, 2005, Page(s): 111-115
  • A Novel Algorithm to Estimate the Pulse Pressure Variation Index
    Aboy, M.; McNames. J; Thong, T.; Phillips, C.R..; Ellenby, M. Goldstein, B. IEEE Transactions on Biomedical Engineering, Volume: 51, Issue: 12, 2004 Page(s): 2198 - 2203
  • A Microcontroller-Based Portable Electrocardiograph Recorder. Segura-Juarez, J.J.; Cuesta-Frau, D.; Samblas-Pena, L.; Aboy, M.; IEEE Transactions on Biomedical Engineering, Volume: 51,Issue: 9, 2004 Pages: 1686 - 1690

For more of Prof. Aboy's publications, see here

 

Selected Patents

Prof. Aboy's granted patents as an inventor include:

  • US 8,920,345 System and apparatus for continuous monitoring of movement disorders
  • US 8,647,287 Wireless synchronized movement monitoring apparatus and system
  • US 8,926,521 Method for blood pressure measurement from noninvasive oscillometric pressure signals
  • US 7,927,283 Blood pressure algorithm
  • US 8,900,153 Ambulatory patient monitoring apparatus, system and method
  • US 8,315,698 Method and apparatus for automatic analysis of T-wave alternans
  • US 8,305,423 Communication system for remote patient visits and clinical status monitoring
  • US 8,057,398 Method, system, and apparatus for cardiovascular signal analysis, modeling, and monitoring
  • US 8,529,458 Method and apparatus for assessment of fluid responsiveness
  • US 8,298,151 Method and apparatus for evaluation of fluid responsiveness
  • US 8,647,287 Method and system for activity/rest identification
  • US 8,862,195 Method, system, and apparatus for automatic detection of obstructive sleep apnea from oxygen saturation recording

For more of Prof. Aboy's patent publications see here.

 

Selected Presentation & Reports 

  • "Mapping the European Patent Landscape for Medical Uses of Known Products", CeBIL Anual Retreat, June 2021

  • "Beyond the FDA 501(k): An Analysis of the De Novo Classification Pathway for Medical Devices", CeBIL Anual Retreat, June 2021

  • "The FDA De Novo Medical Device Pathway, Patents & Anticompetition", CeBIL Anual Retreat 2021

  • "International Transfers of Health Data Between the EU and USA", CeBIL Anual Retreat 2021

  • "The Patentability of Biotech and Precision Medicine Inventions: Subject Matter Eligibility of Gene-Related Patents, Biomarkers, Diagnostics & Algorithms for Personalised Medicine", University of Salamanca, April 2020

  • "Is the Recent Patent Case-Law "Good" for Precision Medicine", CIPIL Anual Spring Conference, March 2020

  • "Are Algorithms Patentable?The Subject Matter Eligibility of Algorithms & Computer-Implemented Inventions" PHG Workshop-Regulating algorithms in healthcare: intellectual property and liability,September 2018

  • "Precision Medicine, AI and the Law Impact of Myriad, Mayo & Alice" 2018 CeBIL Annual Symposium, Precision Medicine, Artificial Intelligence and the Law, September 2018

  • “Myriad’s Impact on Gene Patents. Lessons Learned from Empirical Studies” CeBIL Conference-Innovation Gaps in the Life Sciences Frontiers, March, 2018.

  • Should We Change the EU Law to Disallow DNA Patents? Aboy M. 3rd Annual Philomathia Symposium (2016) 

  • “Analysis of the Impact of the US Supreme Court decision Mayo v Prometheus” Aboy M. Workshop on Realizing Genomic Medicine (2016),