PANEL (4/3): Opiate Regulation Policies – Balancing Pain and Addiction

Opiate Regulation Policies: Balancing Pain and Addiction 

April 3, 2017 12:00 PM

Austin Hall, West Classroom (111)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA

Description

The current opiate epidemic has spurred long-overdue scrutiny on the pharmaceutical production and distribution of opiate medication, but it also raises questions of public policy and law regarding the regulation of medical access to and use of opiate medications with high potential for addiction. Expert panelists will address the challenges that arise from efforts to balance restrictions on access to opiates to limit addiction while also preserving sufficient access for legitimate medical management of pain.

Panelists

  • Monica Bharel, MD, MPH, Commissioner, Massachusetts Department of Public Health
  • David Borsook, MD, PhD, Associate Professor in Anesthesiology, Harvard Medical School; co-director, Center for Pain and the Brain at Boston Children’s Hospital, Massachusetts General Hospital, and McLean Hospital; and affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital
  • Rita Nieves, Deputy Director, Boston Public Health Commission
  • Moderator: Amanda C. Pustilnik, JDProfessor of Law, University of Maryland Carey School of Law; affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital; and 2014-2015 Senior Fellow in Law and Applied Neuroscience as part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center

This event is free and open to the public. Lunch will be provided.

Learn More

Check out the new EdX course “The Opioid Crisis in America,” developed by faculty at Harvard Medical School, to learn more about opioid addiction, evidence-based treatment models, harm reduction approaches that law enforcement and public health officials are using to reduce opioid overdose deaths, and non-opioid alternatives for medical pain management. This online course is free and self-paced; the first session will be available online on March 27, 2017.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Webinars: ASPPH Two-Part Series on PHLR

CPHLR is joining forces with the Association of Schools and Programs of Public Health (ASPPH) for a free, two-part webinar series on public health law research and policy data evaluation.

Public Health Law Research Part I: Creating and Using Open-Source Policy Data for Public Health Evaluation Research
March 29 @ 12:00 pm – 1:00 pm
Will introduce participants to the practice of Policy Surveillance and the various law and policy datasets available through LawAtlas and other open-source portals.
REGISTER >>

Public Health Law Research Part II: Developing and Implementing a Policy Evaluation Using Open-Source Legal Data
April 12 @ 12:00 pm – 1:00 pm
Will introduce participants to the theory, design and implementation of a policy evaluation using policy surveillance datasets.
REGISTER >>

THURSDAY, 3/23! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future: A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading

Will the Recent Workplace Wellness Bill Really Undermine Employee Health Privacy?

By Jessica L. Roberts

While the effort to repeal and replace the Affordable Care Act (ACA) has taken center stage, another health-related bill has been making its way through the House without nearly as much attention. On March 2, 2017, Representative Virginia Foxx (R-NC) introduced House Resolution (HR) 1313 on behalf of herself and Representative Tim Walberg (R-MI).   The bill would lift current legal restrictions on access to genetic and other health-related information. Specifically, HR 1313 targets provisions of the Americans with Disabilities Act (ADA) that prohibit employers from conducting unnecessary medical examinations and inquiries that do not relate to job performance; the Genetic Information Nondiscrimination Act’s (GINA) provisions proscribing employers from requesting, requiring or purchasing the genetic information of their employees; and GINA’s prohibition on group health insurance plans acquiring genetic information for underwriting purposes and prior to enrollment. The bill passed through the Committee on Education and the Workforce last Wednesday along strict party lines with 22 Republicans supporting the proposed legislation and 17 Democrats opposing it.

Despite the public outcry against the bill, HR 1313 may not be as far-reaching as it initially appears. First, while advocates of genetic privacy fear the worst, both the ADA and GINA contain exceptions for wellness programs that already allow employers to access at least some employee health data. Second, even if HR 1313 passes, employees would still enjoy the ADA’s and GINA’s antidiscrimination protections.   HR 1313 could well give employers additional access to genetic and other health-related information about their employees but it is not a license to then use that information to discriminate.

Continue reading

Repeal, Replace and Leave Out Immigrants: The American Health Care Act’s Impact on Immigrants

Given the Trump Administration’s stance on immigration, it probably shouldn’t be surprising that the new health law it is touting, the American Health Care Act (AHCA), will likely have a devastating effect on immigrant and their families. Although not surprising, it should nevertheless be troubling.

Even under the ACA, noncitizen immigrants are far less likely than citizens to have health insurance. In part, this is because immigrants are poorer than the native-born population and are less likely to receive insurance through their workplace. It is also because, contrary to the contentions of its critics, the ACA does not provide any coverage to undocumented immigrants. Indeed, the Obama Administration refused to treat young immigrants who received work permits under the Deferred Action for Childhood Arrival (DACA) program as lawfully in the country and thus eligible to purchase insurance on the exchanges.  In addition, the ACA kept in place the 1996 Personal Responsibility and Work Opportunity Reconciliation Act‘s (PRWORA’s) tight restrictions on immigrants’ eligibility to Medicaid and CHIP. As a result, by 2015, 7 million of the 33 million Americans without insurance were noncitizen immigrants.

Yet although the ACA leaves many immigrants uninsured, it does provide relief to some lawful immigrants. First, it permits lawfully present immigrants who are ineligible for Medicaid to purchase insurance on the exchanges, even if their incomes are below the threshold required for citizens to participate on the exchanges. Second, because immigrants have lower wages than native born citizens, those who are not barred from Medicaid or CHIP due to PROWRA are more likely than native-born citizens to benefit from the ACA’s Medicaid expansion.  More generally, because of their lower wages, immigrants benefit disproportionately from the ACA’s progressivity. Continue reading

Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’

This new post by Claire Laporte appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the ACA also created a new pathway for the approval of biosimilar drugs, which are akin to generic drugs. That pathway appears in a corner of the ACA that has its own title: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is rich with intellectual property (IP) provisions that are now the subject of litigation in the Supreme Court.

Background: Generic Drugs And Biosimilars

Many of us take generic drugs for granted, but we have them only because the Hatch-Waxman Act (1984) provided an abbreviated pathway by which FDA could approve them. Under this pathway, a generic drug could be approved based on the safety and efficacy of the branded drug, plus a showing by the generic that it was essentially identical to the branded drug. This pathway also included provisions by which generic drug manufacturers could challenge the validity of patents protecting the branded drug. […]

Read the full post here.

Another Way to Cut Medical Malpractice Damages?

To limit liability and increase predictability, scholars and policymakers have long focused on capping damages awards.  In particular, they have been worried that there are many runaway jury awards for non-economic damages (i.e., pain and suffering).  Because these are not based on tallies of medical bills or lost wages, these are the least predictable component of the jury’s award.   Still, statutory caps on damages effectively nullify the jury’s determination (and the trial judge’s oversight) of how much to compensate a plaintiff for pain and suffering.  The laws substitute an arbitrary maximum instead (which, in many states, has not adjusted with decades of inflation).

There is now a cottage industry of scholarship that tries to understand the effects of these state caps on payouts, the supply of physicians, liability insurance, economic damages awards, and the aggregate cost of medical care (which may decrease or increase).  (See a synthesis of the literature.)

In new work with John Cambpell and Bernard Chao, I study a different way to cabin jury awards for non-economic damages.  Rather than capping runaway awards ex post, some states have tried to prevent them in the first place, by manipulating what a jury hears in closing arguments.   Continue reading

Genetic counselors, genetic interpreters, and conflicting interests

By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie

The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).

Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.

Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy.  But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Continue reading

NEW EVENT (3/23)! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future: A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading

All-Payer Claims Databases After Gobeille

This new post by Gregory Curfman appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

With health care spending approaching 20 percent of Gross Domestic Product (GDP), controlling health care costs is a top priority not only for the federal government, but also the individual states. To develop successful strategies for cost control, states need comprehensive data on utilization of and spending on health care services. Medicare data are valuable but not representative of the entire national population or of the prices that private payers pay. In private insurance, prices are not under administrative control as they are in Medicare, and they vary widely in different geographic regions.

All-payer claims databases (APCDs) were developed, first in Maryland in 1995, to provide comprehensive state-level data on health-care utilization and spending, and there are now 16 APCDs nationwide. As the name implies, APCDs collect data from all payers, and the spending data reflect the actual negotiated prices of services. Thus, APCDs are a valuable source of information for state health policymakers and health services researchers. For example, in Massachusetts, the Health Policy Commission uses the state’s APCD to set state-wide health care spending targets, which have been important in achieving state cost control. […]

Read the full post here!

Drained Swamps and Quackery: Some Thoughts on Efficacy

“What makes drug development long and expensive is the need to prove, beyond statistical doubt, that your damn drug works”

Michael Gilman, Biotech Entrepreneur

2017 is going to be terrific. Tremendous, even. Things are going to change, big league.

7770160314_61e7536762_kThe new President has promised fantastic reforms to the drug industry. He’s going to get the big players in the pharmaceutical industry around a table and negotiate huge price reductions. Of course, he’s not going to touch their bottom line. If anything, he’s going to improve it. Innovation is being choked by over-regulation and he’s going remove burdensome FDA hurdles. But he has Executive Orders to give and walls to build, so he’s drafting in the very best people to help. We’re still waiting for those people to be officially named. Meanwhile, the media have had a month and a half of fun and speculation. The volume and variety of names being thrown around make it feel like a food fight at a Chinese buffet. One of those names is Peter Thiel.

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NHS patient care and treatment errors: developing a learning culture.

By John Tingle

PACAC, the House of Commons, (Public Administration and Constitutional Affairs Committee) has just published its analysis of the PHSO’s, (Parliamentary and Health Service Ombudsman ) second report into the tragic death of Sam Morrish, a three year old child whose death from sepsis was found to have been avoidable. PACAC  is composed of MP’s (Members of Parliament) and its remit includes considering matters relating to the quality and standards of administration provided by civil service departments which includes the Department of Health. PACAC also examines the reports of the PHSO.

The PACAC report is very thorough and detailed and really gets to grips with the issues surrounding NHS (National Health Service) health adverse incident investigation. It addresses very clearly the current challenges and opportunities in this area and puts forward some major concerns which need to be fully addressed by the NHS before it can be said to have a listening and learning culture. It is clear from reading the report that the NHS has a very long way to go before it can be said to be even close to reaching its listening and learning culture attainment goal.

The PACAC report also identifies what could be regarded as some muddled thinking by the Department of Health on the concept of the ‘safe space’ in NHS investigations and identifies some important patient safety policy gaps.

Continue reading

Potential Changes to National Health Policy and Implications for the Healthcare Industry

Harvard Medical School’s Executive Education program invites you to join Harvard medical faculty and industry leaders to discuss potential changes in national health policy and the effects on the healthcare industry. What do we need to know? What changes are anticipated? How might industry respond? We will explain the current landscape and potential scenarios the country might face in the future.

Date: Thursday March 2nd, 2017 – 5:30pm cocktails, 6:15-8:15pm program
Location: Harvard Medical School Campus – Longwood Avenue, Boston (Room TBD)
Registration: $50 (includes parking, cocktails & hors d’oeuvres)

Register here!

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ACA Repeal and the End of Heroic Medicine

Last week, I saw Dr Atul Gawande speak at Health Action 2017. Healthcare advocates and activists sat around scribbling notes and clutching at their choice of whole-food, cold-pressed, green and caffeinated morning lifelines. Gawande speaks softly, lyrically and firmly; the perfect bedside manner for healthcare advocates in these early days of the Trump presidency. He calmly announced to the congregation that the age of heroic medicine is over. Fortunately, he continued, that’s a good thing.

Gawande’s remarks echoed a piece he published in the New Yorker. He writes that for thousands of years, humans fought injury, disease and death much like the ant fights the boot. Cures were a heady mixture of quackery, tradition and hope. Survival was largely determined by luck. Medical “emergencies” did not exist; only medical “catastrophes”. However, during the last century, antibiotics and vaccines routed infection, polio and measles. X-rays, MRIs and sophisticated lab tests gave doctors a new depth of understanding. New surgical methods and practices put doctors in a cage match with Death and increasingly, doctors came out with bloody knuckles and a title belt. Gradually, doctors became heroes and miracles became the expectation and the norm. This changed the way we view healthcare. Gawande writes, “it was like discovering that water could put out fire. We built our health-care system, accordingly, to deploy firefighters.”

But the age of heroic medicine is over. Dramatic, emergency interventions are still an important part of the system. However, Gawande insists that the heavy emphasis on flashy, heroic work is misplaced. Much more important is “incremental medicine” and the role of the overworked and underappreciated primary care physician.

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“There are millions of people who are living below subsistence”: Black Panther Party Founder Bobby Seale as Public Health Activist

By Wendy S. Salkin

Picture it: Tuesday, February 14, 2017. It is four o’clock and the Tsai Auditorium of the Center for Government and International Studies is packed to the gills, abuzz with energy. Harvard faculty, students, staff, and community members fill every seat, line the steps, and stand shoulder-to-shoulder in the back. They are turning would-be attendees away at the door. The occasion for such excitement is this: The Hutchins Center for African & African American Research here at Harvard hosted the event, “Bobby Seale in Conversation with Jim Sidanius.”

Jim Sidanius is the John Lindsley Professor of Psychology in memory of William James and of African and African American Studies. His work spans broadly across both decades and areas of inquiry. He and his co-author Felicia Pratto are famously responsible for formulating social dominance theory, “a general model of the development and maintenance of group-based social hierarchy and social oppression.” He has also pioneered work in other areas of political psychology, including such research areas as “political ideology and cognitive functioning, the political psychology of gender, group conflict, institutional discrimination and the evolutionary psychology of intergroup prejudice.”

And Bobby Seale, as you may know, co-founded the Black Panther Party for Self Defense (BPP). I had never before seen Bobby Seale speak and did not know what to expect. And, ultimately, I am pleased not to have watched any of his interviews in advance, as I was able to have the experience with fresh eyes. (It’s worth noting that many of his interviews and speeches are easily accessible on YouTube. It’s worth watching them, including his 2015 New York Times interview with R&B artist D’Angelo.) His energy and enthusiasm captivates his audience, as when, during his talk last week, he recited from the Declaration of Independence, and while so doing impersonated both John Wayne and Rev. Dr. Martin Luther King, Jr. He recited this passage:

“[W]hen a long train of abuses and usurpations, pursu[ed] invariably…evinces a design to reduce [a people] under absolute Despotism, [then it is the] right [of the people]…to [alter and change that] Government, and [] provide new Guards for their future security.”

Continue reading

The High Cost of Clinical Negligence Claims

By John Tingle

In the UK, the Department of Health (DH) have just published a consultation paper on introducing fixed recoverable costs in lower value clinical negligence claims. The document contains some controversial proposals which many claimant, patient lawyers are very concerned about. They feel the proposals will make it much harder for patients with lower value claims to find a solicitor to fight their case .The publication of the consultation paper comes in the wake of criticism that some clinical negligence claimant lawyers, solicitor firms , make excessive and unreasonable costs demands. The NHS LA (The National Health Service Litigation Authority) which manages negligence and other claims against the NHS in England states:

“Claimant costs for lower value claims are disproportionate and excessive. For claims where compensation is less than £10,000, claimant lawyers recover almost three times more in costs on average.”(p.10)

The DH Consultation Paper begins by stating the annual cost of clinical negligence in the NHS. It has risen from £1.2bn in 2014/15 to £1.5bn in 2015/2016.Legal costs were 34% of the 2015/16 expenditure.The consultation paper states that the current system of claims resolution is often lengthy and adversarial. This creates what can be termed a dual problem. Delaying possible learning of lessons from incidents and also escalating the costs of litigation when claims are brought. Continue reading

TODAY, 2/13 at 5 PM! Health Law Workshop with Brandon Maher

February 13, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Unlocking Exchanges”

Brendan S. Maher is a Professor of Law and the Director of the independently endowed Insurance Law Center at UConn School of Law. A graduate of Stanford University and Harvard Law School, Maher is the faculty advisor for the peer-reviewed Connecticut Insurance Law Journal and a nationally recognized expert in the regulation of insurance, pensions, and health care. He is a leading authority on the meaning of both ERISA and the Affordable Care Act. Maher also teaches and studies the procedural and evidentiary aspects of civil litigation in federal courts.

Maher is an appointed member of the Connecticut Retirement Security Board, a board created by the state legislature to develop a comprehensive proposal for the implementation of a public retirement plan. He is also the co-moderator of Connecticut’s Forum on Healthcare Innovation, a forum for scholars, investors, providers, scientists, and regulators to share ideas on optimizing health outcomes. He was the chairman of the law school’s “The Affordable Care Act Turns Five” conference, where former United States Secretary of Health and Human Services Kathleen Sebelius was the keynote speaker.

Maher regularly appears before the United States Supreme Court to litigate cases involving employee benefits, preemption, and procedure. One of his cases, LaRue v. DeWolff, Boberg & Associates, was described by The New York Times as “one of the most important rulings in years on the meaning of the federal pension law known as ERISA.” He also studies and is routinely consulted by states, medical providers, and employee organizations as to the applicability of federal law to their activities.

Maher is licensed to practice in several state and federal courts, including the U.S. Supreme Court.

Watching Out for the Rights of the Uninsured

Special Guest Post by Professor Howell E. Jackson, Harvard Law School

As Republicans strive to unwind the Affordable Care Act (ACA), public commentary is quite naturally focusing on the number of Americans who might lose health insurance coverage. The Congressional Budget Office last month estimated that eleven million individuals could drop off of insurance rolls immediately, with millions and millions more to lose coverage within the next few years.  These numbers are indeed troubling, but the fate of the uninsured deserves similar attention.

For those critical of the ACA, uninsured individuals are sometimes characterized as victims of government overreach: penalized with a tax assessment for not complying with the individual mandate, and denied access to the kinds of lower-cost insurance policies that a less regulated insurance market might provide.  And there is some truth to this critique:  Mandatory coverage terms under the ACA do drive up premiums, and of the estimated 27 million Americans now without health insurance coverage, some eight million are paying ACA penalties, totaling on the order of $8 billion a year.  But under the ACA, the uninsured are getting something for those penalties.  In fact, they are getting quite a lot.

As policy analysts often note, the ACA prohibits insurance companies from denying coverage or charging higher premiums based on pre-existing conditions.  This protection is most often discussed in the context of individuals seeking to obtain insurance coverage in the first instance or after losing employer-provided coverage.  A less heralded, but equally important feature of this aspect of the ACA is that it allows healthy Americans the freedom to forgo insurance in the first instance and then purchase reasonably priced coverage when the need arises.  The policies available to uninsured individuals have the full protections of the ACA, including limits on out-of-pocket expenses, as well as prohibitions on annual or lifetime coverage limits and mandated terms of coverage.  In addition, premiums are constrained and, for many individuals and families, premium assistance and cost sharing support are available.   While many despair that a large and possibly growing share of Americans lack insurance coverage, at least the ACA ensures that the uninsured have the right to buy a good health insurance policy at a reasonable price when the need arises. Continue reading

Artificial Intelligence and Medical Liability (Part II)

Recently, I wrote about the rise of artificial intelligence in medical decision-making and its potential impacts on medical malpractice. I posited that, by decreasing the degree of discretion physicians exercise in diagnosis and treatment, medical algorithms could reduce the viability of negligence claims against health care providers.

It’s easy to see why artificial intelligence could impact the ways in which medical malpractice traditionally applies to physician decision-making, but it’s unclear who should be responsible when a patient is hurt by a medical decision made with an algorithm. Should the companies that create these algorithms be liable? They did, after all, produce the product that led to the patient’s injury. While intuitively appealing, traditional means of holding companies liable for their products may not fit the medical algorithm context very well.

Traditional products liability doctrine applies strict liability to most consumer products. If a can of soda explodes and injures someone, the company that produced it is liable, even if it didn’t do anything wrong in the manufacturing or distribution processes. Strict liability works well for most consumer products, but would likely prove too burdensome for medical algorithms. This is because medical algorithms are inherently imperfect. No matter how good the algorithm is — or how much better it is than a human physician — it will occasionally be wrong. Even the best algorithms will give rise to potentially substantial liability some percentage of the time under a strict liability regime.

Continue reading

‘Safe spaces’ in adverse health incident investigation and patient complaints

By John Tingle

Two new reports, one by Action against Medical Accidents,(AvMA),the charity for patient safety and justice and the other by the Patient’s Association charity, (PA), highlight once again significant  problems with NHS (National Health Service) patient safety investigative and complaints structures and procedures.

The Department of Health, (DH) in 2016 produced a consultation paper which closed on 16th December 2016 on providing a ‘safe space’ in healthcare safety investigations.

This is linked to the new NHS, Healthcare Safety Investigation Branch (HSIB),operational from April 2016, and when fully functional will  offer support and guidance to NHS organizations on investigations, and carry out certain investigations itself.Current Government policy is to consider the development of a ‘safe space’ in serious adverse health incident investigations. The Consultation paper stated:

“…many believe that the creation of a type of ‘strong wall’ around certain health service investigations, so that information given as part of an investigation would only rarely be passed on, would provide a measure of ‘psychological safety’ to those involved in investigation, allowing them to speak freely. This will enable lessons to be learned, driving improvement and ultimately saving lives.” (p.8). Continue reading