Is Mike Pence’s Medicaid Expansion a Blueprint for Donald Trump’s Health Care Reform?

By David Orentlicher

[cross-posted at orentlicher.tumblr.com]

Donald Trump’s pledge to repeal and replace the Affordable Care Act has looked much more like a plan for repeal than a plan to replace, especially in light of the kinds of reform proposals advanced by leading Republicans in Congress, including Trump’s designee for Secretary of HHS, U.S. Rep. Tom Price.

But Trump’s recent promise of “insurance for everybody,” suggests that he might actually have a serious replacement in mind. While we cannot automatically take Trump at his word, it may be the case that he is following the example of his Vice President-elect Mike Pence, who as Governor of Indiana defied Republican positioning in signing on to the Affordable Care Act’s Medicaid expansion. Continue reading

The Unhealthy Return to Individual Responsibility in Health Policy

By Allison K. Hoffman, Professor, UCLA School of Law

[cross-posted from RegBlog. see original here]

It is still an open question—at least for a little while longer—what exactly the Republicans’ Affordable Care Act “repeal and replace” promise will entail.  However, the broad contours of the Republican strategy, which both Congress and President Trump have made clear they will pursue at all deliberate speed, are already visible.

Speaker of the House Paul Ryan (R-Wis.) foreshadowed the Republicans’ central approach in his Patient’s Choice Act, a health care plan he put forward in 2009. That plan emphasized a desire to empower individuals to make healthy decisions, asserting that a “large percentage of heart disease, stroke, and type 2 diabetes, as well as many cancers, could be prevented if Americans would stop smoking, start eating better, and start exercising.” According to Ryan, the aim of health reform should be to encourage “individuals to adopt healthy lifestyles and behaviors.”

Ryan’s assumption—a theme also echoed in the other major Republican proposals on the table—is that personal responsibility will serve as a salve to the wounds of the American healthcare system. Impliedly, if Americans would only jog more and eat more vegetables, then we could dramatically reduce cancer and strokes and save a fortune on medical care. Continue reading

Housing Equity Week in Review

We’ve rounded up the latest news from the past week, January 9-15, 2017, for housing law and equity. The HUD confirmation hearing was, of course, the biggest news, but a few other items of note:

Did we miss anything? Let us know!

The Ill-Designed “Continuous Treatment” Rule for the Health Law of Massachusetts

By Alex Stein

Under Massachusetts law, suits alleging medical malpractice in a treatment of a minor patient must be filed “within three years from the date the cause of action accrues.” G.L.c. 231, § 60D. In a recent case, Parr v. Rosenthal, 57 N.E.3d 947 (Mass. 2016), the Supreme Judicial Court of Massachusetts decided that a patient’s continuous treatment by the same physician can toll this period under certain restrictive conditions. One of those conditions requires the plaintiff to show that the physician continued to treat the patient “for the same or related condition” after committing the alleged malpractice, and that “treatment” in that context includes supervision of, as well as consultation and advice to, other treating physicians. Another condition makes continuous treatment part of the discovery rule that moves the onset of the limitations period to the day on which the patient knew or could have reasonably suspected that her physician treated her negligently. According to the Court, continuous treatment instills in the patient “innocent reliance” that the physician treats her properly, which makes the physician’s malpractice not reasonably discoverable. Moreover, innocent reliance can even be present when the patient realizes that she sustained harm from the physician’s treatment. As the Court explained, “A patient who continues under the care of the same physician will still have the same challenges in learning whether the harm [she] suffered from the physician’s treatment arose from the physician’s negligence.” Based on these observations, the Court decided that the “continuous treatment” rule will not benefit patients who affirmatively suspected that they received negligent treatment from their physician. Such patients, the Court held, cannot show “innocent reliance.” Continue reading

Tim Jost on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week we are honored to have a conversation with Professor Tim Jost from Washington & Lee School of Law. Jost, one of our most prolific scholars and astute commentators, not to mention the rock around which the Health Affairs blog is built, looks back at the successes and failures of the ACA, speculates on some of the reasons for its rocky road, and looks ahead to repeal and replacement.

Jost’s posts at Health Affairs are more urgent than ever as the uncertainty around ACA repeal/replace/delay intensifies. While his work on consumer-directed health care is particularly relevant to today’s policy environment, he has also proposed reforms to strengthen the ACA.

For some notes on items we discussed: Frank mentioned an analysis of Tom Price’s plan to replace the ACA, focusing on the plan to “block grant $1 billion dollars a year for four years (or $2.2 million per Congressional District per year) to help states fund high risk pools.” Jost mentioned a Commonwealth Fund report suggesting that amount is not even within two orders of magnitude of the true cost of such pools (at least $100 billion). But at least some people will truly benefit from ACA repeal: the 400 highest-income households each “would get an average tax cut of about $7 million a year,” according to CBPP.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Maybe For-Profit Hospitals Aren’t So Bad

By Shailin Thomas

For-profit hospitals have taken their fair share of flack over the years. Much maligned by many in the medical community, they are seen as money-hungry corporate machines that pervert the medical profession by putting the bottom line before patient care. This skepticism of profit-driven hospitals feels right. Medicine has long been the purview of charitable organizations and religious institutions. It’s supposed to be a calling — a public service to which practitioners are drawn — not a check to cash at the bank.

As for-profit hospitals proliferated, there was research done suggesting they had quality and cost issues stemming from their profit motives. For-profit hospitals had higher mortality rates, employed fewer trained professionals per bed, and were more expensive than their non-profit and government counterparts. Researchers speculated that this was the result of duties owned to shareholders by corporate leaders or compensation incentives for executives based on profitability rather than quality of care. These studies seemed to confirm what many thought they already knew: medicine and money don’t mix well.

More recent studies, however, suggest that for-profit hospitals may have turned over a new leaf. Since 2010, for-profit hospitals have out-performed non-profits in the “Top Performer” evaluation carried out by The Joint Commission — an organization that accredits hospitals in the US — with a higher percentage of for-profit hospitals qualifying for the honor than non-profits. A study published in JAMA from the Harvard T.H. Chan School of Public Health found that hospitals that converted from non-profit to for-profit improved their financial position by increasing their total margins and experienced no change in mortality rates.

Continue reading

PFC Spotlight Series: Faculty Affiliate Ameet Sarpatwari

Learn more about the Petrie-Flom Center’s work through our Spotlight Series, which features interviews with Student and Academic Fellow alumni, as well as current Faculty Affiliates.

sarpatwari_peopleThis week’s post features Ameet Sarpatwari, J.D., Ph.D., who is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL). His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

Read the article to learn more about his contributions to the Center and its mission!

Pharmacist Vaccination Laws, 1990-2016

Since the 1990s, there has been a growing movement to improve access to immunization services by giving pharmacists the authority to administer vaccines.

The newest map on LawAtlas.org explores state laws from 1990 to 2016 that give pharmacists authority to administer vaccines and establish requirements for third-party vaccination authorization, patient age restrictions, and specific vaccination practice requirements, such as training, reporting, record-keeping, notification, malpractice insurance, and emergency exceptions.

As of January 1, 2016:

  • Pharmacists were explicitly authorized to administer vaccines in 46 states and the District of Columbia.
  • Thirteen states and the District of Columbia permit exceptions to vaccination requirements for emergencies or epidemics.
  • Ten states grant pharmacists prescriptive authority to administer vaccines (i.e., pharmacists can vaccinate without a third-party authorization).
US map shows every sate except AL, MS, TN, WA have laws

As of January 1, 2016, every state except Alabama, Mississippi, Tennessee, and Washington had laws that authorized pharmacists to vaccinate.

The dataset was created by Cason Schmit, JD, Research Assistant Professor, Texas A&M University, and Allison Reddick, JD, MPH, Associate Attorney at Hill & Ponton, PA.

Check out the latest map and data at LawAtlas.org.

Public Variant Databases: Data Share with Care

By Adrian Thorogood, BCL, LLB

If every individual has millions of unique variants in their DNA, how can clinicians be expected to tease out a handful of disease causing mutations from a haystack of inconsequential variants? To aid their cause, public human genomic variant databases have sprung up to catalog variants that cause (or do not cause) disease. These databases aggregate, curate and share data from research publications and from clinical sequencing laboratories who have identified a  “pathogenic”, “unknown” or “benign” variant when testing a patient.

International sharing of variant data is “crucial” to improving human health. To inform patient diagnosis or treatment, it is essential that data be accurate and up to date. If variants are collaboratively interpreted by laboratories, databases and treating physicians, who is ultimately responsible for the quality of data? If one actor in the chain does a shoddy job of interpreting variants, resulting in harm to patients, who could be liable? This is the question I pose with Professors Bartha Knoppers and Robert Cook-Deegan in a recent article in Genetics and Medicine: “Public Variant Databases: Liability?”. Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from the rising price of the opioid reversal agent naloxone, to the interpretation of surrogate endpoints in the era of the 21st Century Cures Act, to a comparative assessment of pharmaceutical licensing and reimbursement in the European Union, United States, and Japan. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, et al. Transforming Evidence Generation to Support Health and Health Care Decisions. N Engl J Med. 2016;375(24):2395-2400.
  2. Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone – Risks to Efforts to Stem Overdose Deaths. N Engl J Med. 2016;375(23):2213-2215.
  3. Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan. Clin Pharmacol Ther. 2016;100(6):626-632.
  4. Knopf K, Baum M, Shimp WS, Bennett CL, Faith D, Fishman ML, Hrushesky WJ. Interpretation of surrogate endpoints in the era of the 21st Century Cures Act. BMJ. 2016;355:i6286.
  5. Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016;375(24):2313-2315.
  6. Sinha MS, Kesselheim AS. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorg Med Chem. 2016;24(24):6446-6451.
  7. Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016;31(12):1482-1489.

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda

8:30 – 9:00am, Registration

A continental breakfast will be available.

9:00 – 9:05am, Welcome Remarks

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

9:05 – 10:30am: The End of ObamaCare? Health Care Reform Under A New Administration

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • David Blumenthal, President, The Commonwealth Fund
  • Michael K. Gusmano, Research Scholar, The Hastings Center
  • John McDonough, Professor of the Practice of Public Health, Director of the Center for Executive and Continuing Professional Education, Harvard T. H. Chan School of Public Health
  • Abigail R. Moncrieff, Associate Professor of Law and Peter Paul Career Development Professor, Boston University School of Law
  • Moderator: Einer Elhauge, Caroll and Milton Petrie Professor of Law and Founding Faculty Director, Petrie-Flom Center, Harvard Law School

10:30 – 10:45am, Break

10:45 – 11:10am, Precision Medicine Initiative/Cancer Moonshot

11:10 – 11:35am, Common Rule Update

  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

11:35am – 12:00pm, Clinical Trial Data Sharing

  • TBD, MRCT Center at Harvard

12:00 – 12:25pm, All-Payer Claims Databases

  • Gregory D. Curfman, Editor-in-Chief, Harvard Health Publications, Harvard Medical School

12:25 – 1:00pm, Lunch

Lunch will be provided.

1:00 – 1:25pm, Defining Death, Aid in Dying, and Family Rights

  • Paul Ford, Lecturer, Harvard Medical School, Winter 2017; Director, NeuroEthics Program, Cleveland Clinic; Director of Education, Department of Bioethics, Cleveland Clinic; Associate Professor, CCF Lerner College of Medicine of CWRU

1:25 – 1:50pm, Patient Advocacy, FDA, and Right to Try

  • Jerry Avorn, Professor of Medicine, Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

1:50 – 2:15pm, Drug Pricing and Cost

  • Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School and Brigham and Women’s Hospital

2:15 – 2:40pm, Health IP

2:40 – 2:55pm, Break

2:55 – 3:20pm, Women’s Health

  • Aziza Ahmed, Professor of Law, Northeastern University School of Law

3:20 – 3:45pm, Reproductive Technology and Regulatory Oversight

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School

3:45 – 4:10pm, Legal Responses to Zika

  • George Annas, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law

4:10 – 4:35pm, Flint, Water Safety, and Public Health Infrastructure

  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs

4:35 – 5:00pm, Concussion Litigation and Legislation in Sports

  • Christopher Deubert, Senior Law and Ethics Associate, Petrie-Flom Center Law and Ethics Initiative, Football Players Health Study at Harvard University

5:00pm, Adjourn

Learn More

How did our prognosticators do in predicting health law and policy developments they expected in 2016? Check out videos of all of the presentations at the 4th Annual Health Law Year in P/Review event, held in January 2016, and find out!

Register Now!

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

The Best-Laid Plans For Health Care

This new post by Petrie-Flom’s Faculty Director I. Glenn Cohen appears on the Health Affairs Blog as the first entry in a series that will stem from our Fifth Annual Health Law Year in P/Review event to be held at Harvard Law School on Monday, January 23, 2017.

“The best-laid plans of mice and men often go awry.” This phrase, adapted from the 1785 Robert Burns Poem “To a Mouse” and made as the source of the title of a Steinbeck novella, may become the mantra for health policy in 2017.

The Affordable Care Act (ACA) was the largest and most ambitious alteration to American health policy in a generation. By the middle of 2016, it appeared to be largely “settling into place,” and the quartet of Supreme Court encounters with the law have by now been largely resolved. The Constitutional commerce and taxation clause challenges of NFIB v. Sebelius have been decided, with the Court weakening Medicaid expansion and causing other problems, albeit not ones that threatened the vitality of the overarching statutory scheme due to preservation of the individual mandate.

The decision in King v. Burwell left funding for the insurance Exchanges intact. Controversy over the contraceptive coverage requirements stemming from the Act remains, with the Court punting on the extent to which its analysis from Burwell v. Hobby Lobby ought to apply to challenges raised by other types of objectors in Zubik v. Burwell, leaving the litigants with a strange “Can’t you guys just work this out on remand?” sort of resolution. […]

Read the full post here!

Let’s All Worry About The Effects of Patent Injunctions Against Drug Manufacturers

Yesterday, a federal district judge made an important ruling in the ongoing patent dispute between Amgen’s cholesterol-lowering drug Repatha and Sanofi and Regeneron’s drug, Praluent.  Early in 2016, Amgen’s patents covering the products had been found both valid and infringed, and now Judge Sue Robinson has granted Amgen’s request for an injunction against Sanofi and Regeneron, blocking the two companies from selling Praluent.  (The injunction takes effect in 30 days, giving the companies time to appeal.)

This is very strange.  Let’s be clear: Judge Robinson looked at a situation involving two competing, chemically distinct (though similar) drugs for the same condition and opted to kick one of them off the market, putting Amgen in a monopoly position and taking some number of patients off of the drug they’ve been taking.  As far as Pharma Policy Twitter (h/t Forbes’ always-excellent Matthew Herper) can tell, an injunction of this type happens about once a decade – in 2008 with Amgen and Hoffman-LaRoche regarding an EPO product, and in 1996 with Novo Nordisk and Genentech over hGH products.  (Please send along other examples, if you have them!)

A number of commentators have already weighed in on Judge Robinson’s order, with Professor Jake Sherkow providing a particularly thoughtful tweetstorm on the subject. I largely agree with Professor Sherkow’s analysis, but I want to emphasize two aspects of the case that have not yet received sufficient attention: the first is the decision to ask for the injunction, and the second is the practical effect the injunction will have on patients, on the market, and on the gathering of information about PCSK9 products going forward.

Continue reading

American Psychiatric Association Releases Formal Position Statement on Euthanasia

By Wendy S. Salkin

End of Life Care, NIH

Image Source: NIH Consensus Development Project

Last month, the American Psychiatric Association (APA) released a position statement on medical euthanasia. The statement, approved by the APA Assembly in November and approved by the Board of Trustees in December, states:

The American Psychiatric Association, in concert with the American Medical Association’s position on medical euthanasia, holds that a psychiatrist should not prescribe or administer any intervention to a non-terminally ill person for the purpose of causing death.

According to the APA Operations Manual, APA position statements “provide the basis for statements made on behalf of the APA before government bodies and agencies and communicated to the media and the general public.”

For those who are wondering, What’s the American Medical Association’s [AMA] position on medical euthanasia?, here is your answer: From Section 8 of Chapter 5 (“Opinions on Caring for Patients at the End of Life”) of the AMA Code of Ethics: Continue reading

Mapping Emergency Suspension Powers

Together with the Centers for Disease Control and Prevention and Public Health Management Corporation, the Policy Surveillance Program recently released a new map addressing Emergency Powers laws.

Emergencies might involve dangers to public health, such as an outbreak of the flu; natural disasters, such as floods or earthquakes; or threats to security, such as acts of terror. In 41 states and the District of Columbia, governors are explicitly permitted to suspend laws that would interfere with an efficient, effective response to an emergency. Some states also permit governors to amend laws or create new ones during emergencies.

This new map covers laws granting broad powers to governors to manage emergencies in all 50 states and the District of Columbia.

PHLR spoke with the researchers, Kelly Thompson, JD, Law and Policy Manager at the National Nurse-Led Care Consortium, an affiliate of Public Health Management Corporation, and Nick Anderson, JD, ORISE Fellow at the Centers for Disease Control and Prevention, to discuss their work.

Read on for the full interview! Continue reading

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Continue reading

Tom Price Endangers Women’s Health

In today’s NYTimes, Jill Horwitz and I have an Op-Ed describing why Donald Trump’s selection of Tom Price for secretary of health and human services is a particular threat to women’s health. Read it here!

From the Op-Ed:

With the selection of Representative Tom Price as secretary of health and human services, President-elect Donald J. Trump has taken a giant step toward undermining the health of American women.

It is regrettable, but not surprising, that Mr. Trump has nominated a strident opponent of abortion. It is also no surprise that Mr. Price, an orthopedic surgeon from Georgia, earned a zero rating from Planned Parenthood, an organization he’d like to defund, despite its role in providing preventive health services. […]

Read the full article here!

Naughty or Nice 2016? on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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Here it is! Naughty or Nice 2016?, our irreverent but also quite serious annual survey of who or what has been nice or naughty in health law and policy during the last year. Our experts make some great picks and dig deep into the underlying policy coal and candy. Plus, of course, our “surprise” bonus round as we pick who we would like to welcome singing carols outside our homes! Enormous thanks to our guests: Glenn CohenNicole HuberfeldElizabeth Weeks LeonardJessica Roberts, and Lindsay Wiley.

And a very happy holiday season to all our listeners. See you in ’17!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Missed opportunities to learn from patient deaths in the NHS

By John Tingle

The National Health Service (NHS) in England’s quality regulator, the Care Quality Commission (CQC) has recently published a highly critical report on the way patient deaths are investigated in the NHS. The investigation follows events at the Southern Health NHS Foundation Trust where a number of failings were identified in the way patient deaths were identified and investigated. Certain groups of patients including people with a learning disability and older people receiving mental health care were far less likely to have their deaths investigated by this Trust. The Secretary of State for Health called for a CQC investigation into how acute, community and mental health NHS facilities across the country investigate and learn from deaths. The findings of the report are not good and major improvements in this area are needed across the NHS.

There are failings in openness, transparency and missed opportunities to learn important patient safety lessons. Families of patients and carers told the CQC reviewers that they often have a poor experience of investigations and are not always treated with kindness, respect, honesty and sensitivity. The CQC states that across their review they were unable to identify any NHS healthcare facility that could demonstrate good practice across all aspects of identifying, reviewing and investigating deaths and ensuring that learning from the events is implemented. Continue reading

New Book – Electronic Health Records and Medical Big Data: Law and Policy

Guest Post by author Sharona Hoffman

hoffman-cover-1-002I am pleased to post that my new book, “Electronic Health Records and Medical Big Data: Law and Policy” was recently published by Cambridge University Press.  The book enables readers gain an in-depth understanding of electronic health record (EHR) systems, medical big data, and the regulations that govern them.  It is useful both as a primer for students and as a resource for knowledgeable professionals.

The transition from paper medical records to electronic health record (EHR) systems has had a dramatic impact on clinical care.  In addition, EHR systems enable the creation of “medical big data,” that is, very large electronic data resources that can be put to secondary, non-clinical uses, such as medical research, public health initiatives, quality improvement efforts, and other health-related endeavors.  This book provides thorough, interdisciplinary analysis of EHR systems and medical big data, offering a multitude of technical and legal insights. Continue reading