Alison Hall | PHG Foundation

A qualified lawyer and nurse and longstanding member of an NHS Research Ethics Committee, Alison leads PHG Foundation’s regulation and ethics team. Recent work includes advocacy on data and device regulation that impacts innovations in healthcare. This includes appraising the impact of regulatory changes to EU data protection and medical devices regulation for clinical genetics services and medical research; working with stakeholders and statutory authorities to facilitate optimal data sharing policies in the NHS; and assessing how existing and future in vitro diagnostic devices regulation might impact on IVD device and software development.

Archived news

Transparency found to benefit data sharing in research 5 February 2016
Call for changes to proposals on EU reform of genetic testing services in Europe 16 October 2015
ESHG questions legality of new EU genetic counselling laws 7 April 2014
PHG Foundation report: 100,000 Genomes Project 4 April 2013
Privacy risks and data sharing in genomics 12 April 2010
Government's lacklustre response to Genomic Medicine report lacks urgency and detail 15 December 2009
Impact of legislation and Human Tissue Authority regulation on research 29 October 2009
Rare diseases and the European Parliament 26 May 2009
Human Fertilisation and Embryology Bill clears House of Commons 24 October 2008
UK Human Fertilisation and Embryology Bill update 12 June 2008
The House of Lords debates the revised Human Fertilisation and Embryology Bill 21 December 2007
Human Genetics Commission releases updated report on direct genetic tests 5 December 2007
Government response to scrutiny committee report on the Human Tissue and Embryos (Draft) Bill 10 October 2007
Parliamentary Joint Select Committee report on Human Tissue and Embryos (Draft) Bill 3 August 2007
Meeting report: Genetic Testing of Children 17 July 2007
UK government response to Parliamentary Science and Technology Committee report on hybrids and chimeras 2 July 2007
Human Tissue and Embryos Bill consultation 13 June 2007
Human Tissue and Embryos (Draft) Bill: Joint Parliamentary Committee publishes call for evidence 5 June 2007
Genetics and Insurance Committee publish their 5th Annual report 27 April 2007
Human Rights, Privacy and Medical Research 1 June 2006
The Human Tissue Authority launches the regulatory framework for licensing 27 April 2006
Human Tissue Act passed by Parliament 18 May 2005
Human Tissue Bill published 16 May 2005

Blogs

Moving forward the debate on AI regulation 25 May 2018
Identification and genomic data 13 February 2018
How should UK healthcare prepare for reforms to the EU data protection? 1 August 2017
Review of data security, consent and opt-outs 12 July 2016
Complex diseases need complex solutions – including genomics 21 March 2016
Updated international guidance on human genome and human rights 20 November 2015
Impact of In Vitro Diagnostic Devices regulatory reforms on genetic testing 28 April 2015
Realising Genomics in Clinical Practice - a framework for action 5 December 2014
US clarifies position on secondary findings in clinical genome sequencing 25 November 2014
The impact of genomic sequencing technologies on patient pathways 4 July 2014
AAP guidelines on genetic testing of children: a commentary 27 February 2013
Where are the boundaries for ethical population health policy? 18 January 2013
Do patients have a right to access their clinical sequence data? 14 September 2012
Proposed EU Data Protection reform and public health genomics 16 March 2012

Policy briefing

Somatic genome editing: ethics and regulation 12 November 2019
Somatic genome editing: an overview 21 May 2019
Citizen generated data: the ethics of remote patient monitoring 3 May 2019
Legal liability for machine learning in healthcare 6 September 2018
What is the IVDR? 16 March 2018
Sharing clinical genomic data for better diagnostics 8 October 2014
The impact of genomic sequencing technologies on patient pathways 8 July 2014
Genomics and the boundary between research and clinical care and treatment 25 April 2014
ELSI* and the implemention of WGS / WES in clinical practice 1 January 2014
Realising genomics in clinical practice - project brief 25 December 2013

Consultation responses

Consultation response: developing global standards for governance and oversight of human genome editing 24 August 2020
Public consultation about the Caldicott Principles and Caldicott Guardians 17 August 2020
Response to the EU Commission on a legislative framework for the governance of common European Data Spaces 3 August 2020
Consultation response: Project Explain 31 January 2020
Commercial genomics inquiry 31 May 2019
Review of national cancer screening programmes in England 30 May 2019
National Data Guardian consultation on priorities 25 March 2019
Consultation response: stakeholders consultation on draft AI Ethics Guidelines 4 February 2019
Consultation response: review of the General Medical council consent guidance 4 February 2019
Consultation response: Developing the long term plan for the NHS 14 November 2018
Preparing the healthcare workforce to deliver the digital future 14 November 2018
Consultation on the Centre for Data Ethics and Innovation 12 September 2018
Inquiry on Artificial Intelligence: evidence 23 November 2017
Inquiry on using algorithms for decision-making 30 October 2017
Inquiry on genomics and gene editing in the NHS 24 October 2017
Inquiry on Life Sciences and the Industrial Strategy 6 October 2017
Genome editing open call for evidence - updated response 29 June 2017
Profiling and automated decision making under GDPR 15 May 2017
National Data Guardian for health and care's review of data security, consent and opt-outs 8 September 2016
Call for views and evidence on non-invasive prenatal testing 24 July 2016
Nuffield Council on Bioethics - Genome Editing Open Call for Evidence 1 February 2016
Accelerated Access Review - interim report 6 January 2016
The Big Data Dilemma Inquiry 29 October 2015
Investing in specialised services 4 June 2015
Nurse review of research councils 4 June 2015
Eurogentest guidelines 31 December 2014
The linking and use of biological and health data 9 January 2014
Public Health England: Knowledge Strategy 7 November 2013
Comments on Incidental Findings from the Presidential Commission for the Study of Bioethical Issues 1 October 2013
Tabled amendments to draft EU regulations on in vitro diagnostic medical devices (IVDDR) 7 August 2013
The benefits and harms of breast cancer screening 1 December 2012
The future of the HFEA and HTA 4 July 2012
Innovation Review 1 December 2011
Emerging Biotechnologies 1 June 2011
Healthy Lives, Healthy People 1 January 2011
Liberating the NHS consultation 1 December 2010
Call for evidence on the current data protection legislative framework 1 November 2010
Revision of Directive 98/79 of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices 1 June 2010
Request for Information on the NIH plan to develop the Genetics Testing Registry (GTR) 1 January 2010
A Common Framework of Principles for direct-to-consumer genetic testing services 1 December 2009
Medical profiling and online medicine: The ethics of 'personalised' healthcare in a consumer age 1 November 2009
Genetic testing and common disorders 1 October 2009
The framework for the registration of health and adult social care providers and on the draft regulations 1 June 2009
SACGHS Public Consultation Draft Report 1 February 2009
Regulations to implement the Human Fertilisation and Embryology Act 2008 1 January 2009
Consultation on Secondary Uses of Patient Information 1 December 2008
Consultation on Confidentiality Guidance 1 November 2008
NHS Constitution 1 October 2008
The amendments to the draft charter for bereaved people who come into contact with a reformed coroner system, and on proposals for the Coroners and Death Certification Bill contained in the draft legislative programme 1 September 2008
Consent in Research 1 August 2008
Recast of the Medical Devices 1 June 2008
Good Practice Guide in Paternity Testing Services 1 May 2008
Code of Practice for Genetic Tests 1 April 2008
Revised Codes of Practice to the Human Tissue Act 1 March 2008
Cell-free fetal DNA for non-invasive prenatal diagnosis 1 February 2008
Genomic Medicine 31 January 2008
Data Sharing Review 1 January 2008
Review of the Declaration of Helsinki: Ethical principles for biomedical research involving human beings 1 December 2007
Challenges and priorities for the next five years 1 November 2007
Guidance on nominating a consultee for research involving adults who lack capacity to consent 1 October 2007
A Framework for a Fairer Future: Proposals for a Single Equality Bill for Great Britain 1 January 2007
On the Draft Code of Practice to the Mental Capacity Act 2005 1 November 2006
On Lasting Powers of Attorney (LPA) - forms and guidance (DCA CP 01/06) 1 November 2006
Genetics White Paper: three year review 1 January 2006
On implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics 1 January 2006
'Human Reproductive Technologies and the Law' 1 December 2005
Choices and Boundaries 1 January 2005
Pharmacogenetics 1 December 2004
Choosing the Future: Genetics and Reproductive Decision Making 1 June 2004
'Burial Law and Policy in the 21st Century' 1 January 2004
'Best practice in communicating the results of new scientific research to the public' 1 January 2003
'Unclaimed and unidentified organs and tissue' 1 January 2001

Discussion papers

Impact of Schrems II on genomic data sharing 10 August 2020
Why explainable machine learning matters for health 1 November 2019
A right to explanation? 1 November 2019

Reports

The GDPR and genomic data 1 July 2020
Black box medicine and transparency 29 May 2020
Person centred healthcare 13 October 2019
Overdiagnosis 13 October 2019
Privacy and autonomy 13 October 2019
Algorithms as medical devices 2 October 2019
Regulating algorithms in healthcare: the GDPR and IVDR in practice 1 October 2019
Polygenic scores, risk and cardiovascular disease 19 September 2019
Identification and genomic data 1 January 2018
Personalised prevention in breast cancer – the policy landscape 18 December 2017
Variant classification and interpretation - workshop report 22 June 2017
Data sharing to support UK clinical genetics and genomics services 16 December 2015
Pathogen Genomics Into Practice 8 July 2015
Realising Genomics in Clinical Practice 5 December 2014
Stratified Screening for Cancer 31 January 2014
Realising Genomics in Clinical Practice (interim report) 17 December 2013
Managing incidental and pertinent findings from WGS in the 100,000 Genomes Project 15 April 2013
Next steps in the sequence 25 October 2011
Public health in an era of genome-based and personalised medicine 26 November 2010
Independent response to House of Lords Science and Technology Committee Genomic Medicine report 18 May 2010
Assessment of the Human Tissue Act 1 December 2006

Publications

Genetic database software as medical devices

Thorogood A, Touré S.B, Ordish J, Hall A, Knoppers B.

Human Mutation. 2018; Vol. 39 Iss.11. pp1702-1712.
A response to the forensic genetics policy initiative’s report “Establishing Best Practice for Forensic DNA Databases”

Samuel, G, Howard H.C, Cornel M, van El C, Hall A, Forzano F, Prainsack B.

Forensic Science International. 2018 5 July; Genetics (online).
R isk stratification, genomic data and the law

Hall A, Finnegan T, Susmita C et al.

J Community Genet. 2018;9:195.
Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure.

Murtagh M, B Mwenza, H Alison et al.

Hum Genomics. 2018;12:24
Risk stratification, genomic data and the law.

Hall A, Finnegan T, Chowdhury S, Dent T, Kroese M, Burton H.

J Community Genet. 2018; https://doi.org/10.1007/s12687-018-0358-4. [Epub ahead of print]
Genomic medicine and data sharing

Raza S, Hall A.

Br Med Bull. 2017 Sep; 1;123(1):35-45.
Exploring the potential duty of care in clinical genomics under UK law

Mitchell C, Ploem C, Chico V, Ormondroyd E, Hall A, Wallace S, Fay M, Goodwin D, Bell J, Phillips S, Taylor J.C, Hennekam R, Kaye J.

Medical Law International. 2017 Aug 14 [Epub ahead of print]
What ethical and legal principles should guide the genotyping of children as part of a personalised screening programme for common cancer?

Chowdhury S, Hall A, Pashayan N, Pharoah P.

Journal of Medical Ethics. 2013 Mar 1 [Epub ahead of print] PubMed PMID: 23454719
Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report

Bewshea C, Carrieri D, Hall A, Walker G.

J Med Ethics doi:10.1136/medethics-2016-103530
Responsible implementation of expanded carrier screening

Henneman L, Borry P, Hall A.

Eur J Hum Genet. 2016 Jun; 24(6)w1-e12.
Known unknowns: building an ethics of uncertainty into genomic medicine

Gaff C, Hall A, Leonard S, Newson A.

BMC Medical Genomics (2016) 9:57 DOI 10.1186/s12920-016-0219-0
Non-invasive prenatal testing for aneuploidy and beyond: challenges of responsible innovation in prenatal screening

de Wert G, Dondorp W, Hall A.

European Journal of Human Genetics. 2015 March 18.
Considerations in establishing a post-mortem brain and tissue bank for the study of myalgic encephalomyelitis/chronic fatigue syndrome: a proposed protocol

Bowman E, Goldring K, Gveric D, Hall A, Lacerda E, Nacul L, O'Donovan D, Pheby D.

BMC Research Notes. 2014; (7):370.
Personalized medicine: what's in a name?

Burton H, Hall A, Kroese M, Pokorska-Bocci A, Sagoo G, Stewart A.

Personalised Medicine. 2014; 11(2):197-210.
Revealing the results of whole-genome sequencing and whole-exome sequencing in research and clinical investigations: some ethical issues

Alberg C, Hall A, Hallowell N, Zimmern R.

Journal of Medical Ethics. Epub 2014 Jul 18.
A Toolkit to assess health needs for congenital disorders in low- and middle-income countries: an instrument for public health action

Nacul L,Stewart A, Alberg C, Chowdhury S, Burton H, Darlison MW, Grollman C, Hall A, Modell B, Moorthie S, Sagoo G, .

Journal of Public Health. 2014 June; 36(2):243-50. doi: 10.1093/pubmed/fdt048 : May 10, 2013 [Epub ahead of print]
Personalised medicine in the UK: challenges of implementation and impact on healthcare system

Burton H, Hall A, Kroese M, Pokorska-Bocci A, Sagoo G.

Genome Medicine. 2014 Apr 25; 6(4):28.
What ethical and legal principles should guide the genotyping of children as part of a personalised screening programme for common cancer?

Burton H, Chowdhury S, Hall A, Pashayan N, Pharoah P.

Journal of Medical Ethics. 2014 Mar; 40(3):163-7.
Public health genomics and personalised prevention: lessons from the COGS project

Burton H, Chowdhury S, Dent T, Hall A, Pashayan N, Pharoah P.

Journal of Internal Medicine. 2013 Nov; 274(5):451-6
Life insurance: genomic stratification and risk classification

Burton H, Chowdhury S, Dent T, Feze I, Foulkes W, Hall A, Hamet P, Joly Y, Kirwan N, Knoppers B, Macdonald A, Pashayan N, Simard J, Van Hoyweghen I.

European Journal of Human Genetics. 2013 Oct 16. doi: 10.1038/ejhg.2013.228
Implementing risk-stratified screening for common cancers: a review of potential ethical, legal and social issues

Burton H, Chowdhury S, Dent T, Hall A, Pashayan N, Pharoah P.

Journal of Public Health (Oxf). 2013 Aug 28.
Public health implications from COGS and potential for risk stratification and screening

Burton H, Chowdhury S, Dent T, Hall A, Pashayan N, Pharoah P.

Nature Genetics. 2013 Apr; 45(4):349-51 doi: 10.1038/ng.2582. PubMed PMID: 23535723
Informatics and clinical genome sequencing: opening the black box

Moorthie S, Hall A, Wright C.

Genet Medicine. 2013 Mar; 15(3):165-71.
Incorporating genomics into breast and prostate cancer screening: assessing the implications

Burton H, Chowdhury S, Dent T, Hall A, Hall P, Lyratzopoulos G, Pashayan N, Pharoah P.

Genetics in Medicine. 2013 Feb 14 doi: 10.1038/gim.2012.167. [Epub ahead of print] PubMed PMID: 23412607.
Stratified cancer screening: the practicalities of implementation.

Burton H, Chowdhury S, Dent T, Eccles D, Eeles R, Hall A, Jbilou J, Lyratzopoulos G, Pashayan N, Pharoah P, Rafi I, Segnan N, T.

Public Health Genomics. 2013;16(3):94-9.
Legal and ethical implications of inherited cardiac disease in clinical practice within the UK

Burton H, Hall A.

Journal of Medical Ethics. 2010; 36: 762-766.
Extending the reach of public health genomics: What should be the agenda for public health in an era of genome-based and "personalized" medicine?

Burke W, Hall A, Karmali M, Khoury M, Knoppers B, Meslin E, Stanley F, Wright C, Zimmern R.

Genetics in Medicine. 2010 Nov; Vol 15.
Regulating direct-to-consumer genetic tests: What is all the fuss about?

Hall A, Wright C, Zimmern R.

Genetics in Medicine. 2010 Oct 1 [Epub ahead of print]
Non-invasive prenatal diagnosis using cell-free fetal DNA technology: applications and implications

Bostanci A, Hall A, Wright C.

Public Health Genomics. 2010; 13(4):246-55. Epub 2010 Apr 15.
Inherited cardiovascular conditions: the challenges of genomic medicine

Alberg C, Burton H, Hall A, Inherited Cardiovascular Conditions Services , Sagoo G, Stewart A.

Heart. 2010 Mar; 96(6):474-6
Biomarkers, Dementia, and Public Health

Brayne C, Hall A, Matthews F, Wright C.

Annals of the New York Academy of Sciences. 2009; 118:11-19.
Beyond Bristol and Alder Hey: The Future Regulation of Human Tissue

Hall A, Liddell K.

Medical Law Review. 2005; Summer:170-223

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