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1110962

registered interest
date	10/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medical Equipment: Computers
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effect of the regulation of section 6 of the Health and Safety at Work Act 1974 on medical devices containing computers.
tabling member constituency	Vauxhall
tabling member printed	Kate Hoey
uin	243321
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>The Department has not made any assessment of the effect of the regulation of section 6 of the Health and Safety at Work Act 1974 on medical devices containing computers.</p><p> </p><p>Section 6 of the Health and Safety at Work Act 1974 places duties on any person who designs, manufacturers, imports or supplies any article for use at work to ensure that it will be safe and without risks to health. In general this applies to all devices used in the workplace but there are exceptions, such as medical devices, which are regulated by specific regulations that set out more detailed duties.</p><p> </p><p>The Medical Devices Regulations 2002 deal with the design, manufacture, import or supply of medical devices, including those which may contain computers/software. It is for the designer, manufacturer, importer or supplier to demonstrate that their product is safe. These regulations transpose the requirements of the following European Directives concerning product safety for medical devices:</p><p>- Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD)(1990);</p><p>- Council Directive 93/42/EEC on Medical Devices (MDD)(1993); and</p><p>- Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD)(1998).</p><p> </p><p>The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the United Kingdom. The following link provides more information on MHRA and its role:</p><p> </p><p><a href="https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety" target="_blank">https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety</a></p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 15/04/2019 14:26:12 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	210 label Biography information for Baroness Hoey

1110965

registered interest
date	10/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Infant Mortality
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 1 May 2018 to Question 137006, whether he commission an assessment of the reasons for the trends in data provided by the Office for National Statistics in relation to infant mortality rates in households in different income quintiles.
tabling member constituency	Birkenhead
tabling member printed	Frank Field
uin	243351
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>We have not commissioned such an assessment. Public Health England (PHE) monitors trends in infant mortality at national and local level as part of the Public Health Outcomes Framework, which is statutory guidance for local authorities and published on PHE’s fingertips platform. Inequalities in infant mortality are monitored by decile of deprivation, which is updated every year and available at the following link:</p><p><a href="https://fingertips.phe.org.uk/profile/public-health-outcomes-framework/data#page/7/gid/1000044/pat/6/par/E12000001/ati/102/are/E06000005/iid/92196/age/2/sex/4" target="_blank">https://fingertips.phe.org.uk/profile/public-health-outcomes-framework/data#page/7/gid/1000044/pat/6/par/E12000001/ati/102/are/E06000005/iid/92196/age/2/sex/4</a></p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 15/04/2019 12:45:51 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	478 label Biography information for Lord Field of Birkenhead

1111021

registered interest
date	10/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medical Records
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps his Department is taking to improve data sharing between private and NHS hospitals.
tabling member constituency	Coventry South
tabling member printed	Mr Jim Cunningham
uin	243337
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>The Acute Data Alignment Programme (ADAPt) was established on 9 January 2018, and was launched in June 2018. The ADAPt Programme is jointly led by NHS Digital and the Private Healthcare Information Network (PHIN) in partnership with stakeholders from the Department, NHS Improvement, NHS England, and the Care Quality Commission.</p><p> </p><p>The programme has served to develop good working relationships between PHIN, NHS Digital and key stakeholders. The first phase focuses on ensuring that independent hospitals and National Health Service private patient units are submitting robust, complete and accurate data to PHIN, and that performance measures already required to be published by Order of the Competition and Markets Authority can be achieved as quickly as possible. The second phase will ensure the data flows from independent providers into NHS Digital, just as it does from NHS providers, enabling consistency in measurement and understanding of both risk of harm and health outcomes for patients wherever they are treated.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 15/04/2019 12:38:56 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	308 label Biography information for Mr Jim Cunningham

1111113

registered interest
date	10/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Pregnancy Tests
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 9 April 2019 to Question 239926 on Pregnancy Tests, for what reason previous studies were not considered robust; and what the extensive limitations were.
tabling member constituency	Bolton South East
tabling member printed	Yasmin Qureshi
uin	243382
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests considered that the key limitations of previous studies related to the accuracy of recording of what drug was taken by the women; clarity over the timing of administration during pregnancy; adjustment for confounding factors; selection of controls; and the statistical methodology.</p><p> </p><p>The Expert Group used a quality scoring system to evaluate the quality of each individual study according to a set of seven pre-defined quality criteria. The criteria and score agreed by the Expert Working Group for each study are published in Annex 27 of the final report.</p><p> </p><p>The criteria for selecting members of the Expert Working Group were based on the expertise needed to evaluate all aspects of the questions before the Group and the types of data that would need to be assessed. Membership included those with expertise in pharmaco-epidemiology, including perinatal and paediatric epidemiology, medical statistics, embryology, clinical genetics, gynaecology, reproductive endocrinology, toxicology and pharmacology.</p><p> </p><p>The process for selecting members was in line with established policy for expert groups of the Commission on Human Medicines, with the nominations being agreed by the Commission and endorsed by Ministers.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 243383 question first answered 15/04/2019 14:23:24 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	3924 label Biography information for Yasmin Qureshi

1111114

registered interest
date	10/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Hormone Pregnancy Tests Expert Working Group
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what the criteria were for selecting members of the Expert Working Group for Hormone Pregnancy Tests.
tabling member constituency	Bolton South East
tabling member printed	Yasmin Qureshi
uin	243383
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests considered that the key limitations of previous studies related to the accuracy of recording of what drug was taken by the women; clarity over the timing of administration during pregnancy; adjustment for confounding factors; selection of controls; and the statistical methodology.</p><p> </p><p>The Expert Group used a quality scoring system to evaluate the quality of each individual study according to a set of seven pre-defined quality criteria. The criteria and score agreed by the Expert Working Group for each study are published in Annex 27 of the final report.</p><p> </p><p>The criteria for selecting members of the Expert Working Group were based on the expertise needed to evaluate all aspects of the questions before the Group and the types of data that would need to be assessed. Membership included those with expertise in pharmaco-epidemiology, including perinatal and paediatric epidemiology, medical statistics, embryology, clinical genetics, gynaecology, reproductive endocrinology, toxicology and pharmacology.</p><p> </p><p>The process for selecting members was in line with established policy for expert groups of the Commission on Human Medicines, with the nominations being agreed by the Commission and endorsed by Ministers.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 243382 question first answered 15/04/2019 14:23:24 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	3924 label Biography information for Yasmin Qureshi

1110537

registered interest
date	09/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medical Treatments: Prescription Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what assessment the Government has made of the effectiveness of the implementation of the guidance entitled Items which should not be routinely prescribed in primary care: Guidance for CCGs.
tabling member constituency	Rother Valley
tabling member printed	Sir Kevin Barron
uin	242690
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>We are informed by NHS England that in the period up to and including October 2018, spend on the 18 low priority medicines has fallen by £31.1 million from £133.6 million, compared to 2016/17. This represents a reduction of 23%.</p><p> </p><p>The volume of medicines prescribed reduced by 27% and the number of patients prescribed these medicines reduced by 32%.</p><p> </p><p>In addition, NHS England has worked with PrescQIPP and the NHS Business Services Authority to refine its assessment of the amount of money spent on over the counter medicines.</p><p> </p><p>In the 12 months to January 2019, the total National Health Service spend in England on over the counter medicines was £449.4 million. This was a saving on total spend of £25.9 million from the 12 months to January 2018, which was £475.3 million. This saving does not account for the potential impact to the NHS from a reduced number of general practitioner appointments, for which no assessment has been made.</p><p> </p><p>These savings will be reinvested into the NHS, ensuring patients can access high quality care now and in the future.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 15/04/2019 12:55:04 answering member 4455 label Biography information for Seema Kennedy
tabling member	392 label Biography information for Sir Kevin Barron

1110538

registered interest
date	09/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Medical Treatments: Prescription Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to the guidance published by NHS England, Items which should not routinely be prescribed in primary care: Guidance for CCGs, what estimate his Department has made of the number of patients that have been refused prescriptions for over-the-counter medicines by their GP since the publication of that guidance.
tabling member constituency	Rother Valley
tabling member printed	Sir Kevin Barron
uin	242691
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>The Department has made no assessment of the number of patients refused prescriptions for over the counter medicines.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 15/04/2019 12:58:58 answering member 4455 label Biography information for Seema Kennedy
tabling member	392 label Biography information for Sir Kevin Barron

1110546

registered interest
date	09/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Breast Cancer: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether there are breast cancer medicines that are not expected to have a six-week supply stockpiled by 12 April 2018.
tabling member constituency	Carshalton and Wallington
tabling member printed	Tom Brake
uin	242661
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>Leaving the European Union with a deal remains the Government’s top priority. However, as a responsible Government we must plan for every possible outcome including ‘no deal’.</p><p> </p><p>The Government has been working closely with industry to ensure the supply of medicines, including medical radioisotopes, can continue uninterrupted in the event of a ‘no deal’ EU exit.</p><p> </p><p>The Department is unable to discuss specific companies and medicines because, to reassure participating companies, we have committed to treating all information received confidentially, securely and to use it only for the purposes of the Department’s programme. However, we continue to work with all suppliers to ensure their plans remain on track.</p><p> </p><p>We are confident that, if everyone does what they need to do, the supply of medicines and medical products will be uninterrupted.</p> answering member constituency Wimbledon answering member printed Stephen Hammond question first answered 15/04/2019 12:50:14 answering member 1585 label Biography information for Stephen Hammond
tabling member	151 label Biography information for Tom Brake

1110548

registered interest
date	09/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Department of Health and Social Care: Databases
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the Government's development of combined interpretable data sets.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	242861
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>Access to comprehensive, accurate and timely data is critical to the safe, effective and efficient running of the health and social care system in England. We set out our ambition to introduce and use new technology including the innovative use of data in ‘The future of healthcare: our vision for digital, data and technology in health and care’.</p><p> </p><p>Our focus is on getting the digital architecture of the health and care system right, including open standards, secure identity and interoperability, which are critical to the safe and successful use of technology, ensuring that systems talk to each other and that the right data gets to the right place at the right time.</p><p> </p><p>New technologies offer great potential to support preventative, predictive and personalised care. For example, enabling data sets to be linked effectively provides the opportunity to use data-driven technologies such as artificial intelligence to help diagnose diseases or conditions and to gain better insights into treatments and preventions that could benefit all of society.</p><p> </p><p>We recognise that despite recent progress and many areas of excellence the digital transformation of the health and care system is the most important change we will make over the next decade. In order to do this effectively and efficiently, we have established NHSX to bring together in one place the responsibility for driving the transformation of technology, digital and data policy and implementation.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 15/04/2019 14:33:20 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4398 label Biography information for Chris Green

1110551

registered interest
date	09/04/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps is the Government taking to ensure timely access to maintenance medication for people with cancer.
tabling member constituency	Sheffield South East
tabling member printed	Mr Clive Betts
uin	242692
answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>The Department fully understands that maintaining access to cancer medication is vitally important to many people in this country.</p><p> </p><p>There is already a team within the Department that deals with medicine supply issues arising both in the community and hospitals. We have well established procedures to deal with medicine shortages, from whatever cause, and work closely with the Medicines and Healthcare products Regulatory Agency, the pharmaceutical industry, NHS England and others operating in the supply chain to help prevent shortages and to ensure that the risks to patients are minimised when they do arise.</p><p> </p><p>If we are aware of issues with cancer medications we work with national clinical experts to advise on management plans and ensure that appropriate information is provided to the National Health Service and specialist patient groups.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 15/04/2019 12:58:08 answering member 4455 label Biography information for Seema Kennedy
tabling member	394 label Biography information for Mr Clive Betts