Our independent healthcare in house lawyers' forum covered the following topics: • healthcare procurement law update – a review of the Light Touch Regime (LTR) and recent trends; and • regulatory law update.

1. Independent healthcare in house lawyers’ forum
September 2017

2. Procurement and new models
of care
Rachel Whitaker
Associate Commercial Health

3. Discussion points
• Procurement
– Light touch regime
– Talking points?
• New models of care
– STPs
– Opportunities
– Procurement

4. Light touch regime
• Introduced in Public Contracts Regulations 2015
– Into force for healthcare contracts 18th April 2016
• Light Touch Regime applies to services in Schedule
3 e.g.:
– Health, social and related services
– Administrative social, educational, healthcare and
cultural services
• Establishes a threshold above which contracts must
be subject to a procurement process

5. Light Touch Regime - process
• LTR does not specify type of procedure to be
followed
– Commissioner discretion
– Compliance with principles of transparency and
equal treatment
– Compliance with own specified rules
– Timescales must be reasonable and proportionate
• Reg 32 use of negotiated procedure without prior
publication – applies to LTR

6. Talking points
• LTR and National Health Service (Procurement,
Patient Choice and Competition) (No. 2)
Regulations 2013
– Application of both?
– Importance of NHS Regs
• Key procurement issues in health:
– STPs
– New care models

7. New models of care
• 5 Year Forward View
• New models of care:
– ACO/ ACS
– MCP
– PACS
– Urgent and emergency care
– Enhanced health in care homes
– Acute care collaborations

8. New care model opportunities
• STP plans
• Market engagement events
• Consultations

9. Making the most of opportunities
• Identifying commissioner opportunities
• Identifying potential partners
• Supporting a bid:
– Capacity
– Legal structure
– Contractual structure
– Due diligence
– ISAP

10. Contact us…
Rachel Whitaker
E: Rachel.Whitaker@brownejacobson.com
T: +44 (0)115 976 6538

11. Independent healthcare:
Regulatory law update
Carl May-Smith, Associate Barrister
Browne Jacobson LLP
September 2017

12. Overview
• CQC and the “next phase of regulation”
• National Minimum/Living Wage interpretation
• Regulation of medical devices

13. CQC and the “next phase of
regulation”
• CQC inspection and assessment
– 11 frameworks reduced to 2
 Healthcare services
 Adult social care services
 November 2017 onwards
– New and “strengthened” themes and KLOEs
 All Key Qs, especially Well Led
– Changes to internal QA systems required

14. CQC and the “next phase of
regulation”
• Registration - learning disability and autism care
– Revised “Registering the right support” guidance
issued
– Potentially relaxed application of “Building the
right support” guidance
– First registration appeal
– Making the case for another model

15. CQC and the “next phase of
regulation”
• Consultation 2 ended August 2017
– Parent company registration
– Looking to bring online primary
care into ratings scope
– Changes to adult social care
regulation
 Online information collection
– Increased sharing of fit and proper
person concerns

16. Expanding CQC ratings
• CQC ratings of independent healthcare to be
expanded
– Cosmetic surgery
– Substance misuse
• Additional consultation ends 6 November 2017
– Inclusive approach
 Independent community health services
 Independent doctors including online

17. National Minimum/Living Wage
interpretation
• Travelling time
• Sleeping night staff
– Is your staff member working?
– NMW Regs 2015 s32 – “hours when the worker is
awake for the purposes of working”
– DBEIS guidance April 2017 – sleeping care worker an
example of working whilst asleep
– Mencap - #StopSleepInCrisis
– Consequences of breach & enforcement suspension

18. Regulation of Medical Devices
• Regulation (EU) 2017/745 on medical devices
– Expanded definition including for software
 Prediction/prognosis and enable/assist function
– Pre-market compliance
 Unannounced inspections and RCMs
– Post-market monitoring
 UDIs and clinical investigations data
– Transition period to 25 May 2020
– Similar in vitro diagnostic medical devices Regs

19. Contact us…
Carl May-Smith, Associate Barrister
E: carl.may-smith@brownejacobson.com
T: +44 (0)115 934 2024
www.bjhealthlawyers.com

20. All information correct at time of production.
The information and opinions expressed within this
document are no substitute for full legal advice. It is for
guidance only and illustrates the law as at the published
date. If in doubt, please telephone us on 0370 270
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© Browne Jacobson LLP 2017 – The information
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