Matt Hancock, the recently appointed Government, Health and Social Care Secretary, made a keynote speech on patient safety in London recently. The speech spelled out the future direction of NHS (National Health Service) patient safety policy development in England and also contained some very useful observations and policy which have relevance to patient safety policy developers globally, as well as in England.
Tag: health law policy
Cottage Food and Food Freedom Laws – New LawAtlas data
The newest map on LawAtlas.org analyzes state laws governing the production, sale, and regulation of cottage food operations.
Typically, commercial food production is required to take place in certified commercial kitchens that are heavily regulated. Cottage foods laws regulate the production and sale of certain foods (foods less likely to cause foodborne illness, such as jams and baked goods) made in home kitchens, rather than a licensed commercial kitchen, and a person’s ability sell them in venues like farm stands or retail stores. Similar state laws, called “food freedom laws,” expand upon cottage food laws to include potentially hazardous products like meat and poultry.
These laws are quickly becoming an increasing area of debate at the state level. Part of this debate centers on the economic rights of “small-batch” home bakers and cooks versus public health and safety concerns. These private bakers, canners, and cooks want the liberty to sell their products to consumers free from the onerous licensing requirements required of their larger commercial counterparts, restaurants and food processing plants, are subject to. At the same time, there is concern that this individual economic interest is riding roughshod over existing regulations designed to protect consumers from foodborne illnesses that can be caused by improperly prepared foods.
DNA Donors Must Demand Stronger Privacy Protection
By Mason Marks and Tiffany Li
An earlier version of this article was published in STAT.
The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.
DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Read More
A data set that looks like America
By Oliver Kim
May marks the annual Asian American and Pacific Islander Heritage Month, which recognizes the history and contributions of this diverse population in the United States. Accounting for that diversity though is one of the challenges facing the Asian American-Pacific Islander (AAPI) community: for example, the Library of Congress commemorative website recognizes that AAPI is a “rather broad term” that can include
all of the Asian continent and the Pacific islands of Melanesia (New Guinea, New Caledonia, Vanuatu, Fiji and the Solomon Islands), Micronesia (Marianas, Guam, Wake Island, Palau, Marshall Islands, Kiribati, Nauru and the Federated States of Micronesia) and Polynesia (New Zealand, Hawaiian Islands, Rotuma, Midway Islands, Samoa, American Samoa, Tonga, Tuvalu, Cook Islands, French Polynesia and Easter Island).
Understanding that diversity has huge policy and political implications, particularly in health policy. Read More
Facebook Should ‘First Do No Harm’ When Collecting Health Data
By Mason Marks
Following the Cambridge Analytica scandal, it was reported that Facebook planned to partner with medical organizations to obtain health records on thousands of users. The plans were put on hold when news of the scandal broke. But Facebook doesn’t need medical records to derive health data from its users. It can use artificial intelligence tools, such as machine learning, to infer sensitive medical information from its users’ behavior. I call this process mining for emergent medical data (EMD), and companies use it to sort consumers into health-related categories and serve them targeted advertisements. I will explain how mining for EMD is analogous to the process of medical diagnosis performed by physicians, and companies that engage in this activity may be practicing medicine without a license.
Last week, Facebook CEO Mark Zuckerberg testified before Congress about his company’s data collection practices. Many lawmakers that questioned him understood that Facebook collects consumer data and uses it to drive targeted ads. However, few Members of Congress seemed to understand that the value of data often lies not in the information itself, but in the inferences that can be drawn from it. There are numerous examples that illustrate how health information is inferred from the behavior of social media users: Last year Facebook announced its reliance on artificial intelligence to predict which users are at high risk for suicide; a leaked document revealed that Facebook identified teens feeling “anxious” and “hopeless;” and data scientists used Facebook messages and “likes” to predict whether users had substance use disorders. In 2016, researchers analyzed Instagram posts to predict whether users were depressed. In each of these examples, user data was analyzed to sort people into health-related categories.
New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL
Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University: Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director
Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility.
The article, written by the Law and Ethics Initiative of the Football Players Health Study at Harvard University, examines whether the U.S. Occupational Safety and Health Administration (OSHA) should take an active role in improving health and safety in the NFL workplace.
The article concludes that while OSHA clearly has the authority to regulate the NFL, there is little to no precedent or guidance for OSHA to insert itself into the on-the-field aspects of professional sports. The small body of case law that bears on OSHA’s authority in entertainment and sports opens some doors for OSHA to issue standards for the NFL but also sets some limits on its ability to alter the nature of the game. Adding a public institution like OSHA as a party to existing labor-management discussions concerning health and safety may be the best natural evolution of the issue, the report says, mapping a pathway for OSHA to step up to this challenge. Read More
The Health Service Ombudsman: NHS Failing Patients with Mental Health Problems
By John Tingle
Failings in National Health Service (NHS) care for patients with mental health problems is a worryingly persistent story in the English media. Many reports show harrowing and dramatic failings in NHS care provision for the mentally ill some of which result in avoidable deaths.The Health Service Ombudsman (HSO) represents the final stage in the NHS complaints procedure and is an independent office reporting directly to Parliament.The HSO carry’s out investigations into complaints and makes the final decisions on those that have not been resolved by the NHS in England.In a recently published report the HSO reveals reveals unjust, shocking and tragic failings in NHS care provision for patients with mental health problems.Some mental health care complaints figures are given in the report.In 2016-2017 there were 14,106 complaints made to NHS mental health trusts (hospitals) with ,65% being upheld or partly upheld by the local organisation.Case work data between 2014-15 and 2017-18 was analysed and five key themes showing persistent failings that the HSO see in complaints being made emerged from this exercise:
- Diagnosis and failure to treat.
- Risk assessment and safety
- Dignity and human rights.
- Communication.
- Inappropriate discharge and provision of aftercare.
The HSO also points out in the report that the other common factor in the cases examined is too frequent substandard complaint handling by the NHS organisation. This adds insult to injury, compounding the impact of failings. Read More
Systemic Oversight: a new approach for precision medicine and digital health
By Alessandro Blasimme and Effy Vayena
Imagine a clinical research protocol to test the efficacy of a nutritional regime on the aging trajectory of the participants. Such a study would need to be highly powered and include thousands of people in order to observe a credible effect size. Participants would remain enrolled in the study for many years, maybe decades. Endpoints would include novel measures of healthy aging such as functioning (the capacity to perform certain activities) and the quality of social life. Participants would thus be asked to provide enormous amounts of personal data covering at the same time their health state, their habits and their social activities – most likely with the help of smart appliances, sensor-equipped wearables, mobile phones and electronic records.
In a different scenario a research team aims to develop clinical protocols for cancer treatment according to the unique genomic signature of their tumor. They will need patients, willing to undergo whole genome germline and tumor sequencing right at the moment of diagnosis and be included in a basket trial. Therapy would then be targeted to the specific genetic alterations of each individual in the hope that a combination of targeted drugs would generate better medical outcomes than the current standard of care.
These two scenarios correspond to the prototypical form of, respectively, precision medicine and precision oncology studies. The first is likely to require large (very large) longitudinal cohorts of extensively characterized individuals – like the All of Us Research Program. The second will require sustained sharing of genomic data, information on patients’ clinical history and response to treatment, and possibly a unique repository in which such information would flow to – something akin the NCI’s Genomic Data Common.
This kind of data-intense research, in particular, introduces game changing features: increased uncertainty about foreseeable data uses, expanded temporal span of research activities due to virtually unlimited data lifecycles, and finally, the relational nature of data. This last feature refers both to the fact that, for instance, zip codes contain other types of sensitive information like information about ethnic background (redundant encoding); and to the fact that data about one person contain information about others– as is the case, for instance, with genetic data among family members. Read More
Failings in care for patients being treated under the Mental Health Act 1983
By John Tingle
The Care Quality Commission (CQC) is the independent regulator of health and social care in England and they have recently produced their annual report to Parliament on how health services are applying the Mental Health Act 1983 (MHA) .This report, shines a very strong light on failing health care practices in mental health care relating to the MHA. Shocking failures are revealed and the errors are compounded by the fact that the poor practices have been identified in previous reports and are long standing in nature.
The CQC state that national data from the last 25 years shows an increasing use of the MHA to treat people in hospitals. From 2005/06 to 2015/16, the reported number of uses of the MHA to detain people in hospital increased by 40%. There was a 9% increase from 2014/15 to 2015/16 rising to 63,622 uses of the MHA. The CQC can find no single cause for the increases in detention rates over the last 10 years.
The CQC once again draw attention to the persistent theme present in its previous reports of black and minority ethnic over representation figures in the use of the MHA.
The CQC found that there are still services that continue to fail in their legal duties to give patients information about their rights, verbally and in writing as soon as possible after their detention or community treatment order commences. They found no evidence that staff had discussed rights with the patient on admission in 11 % (378) of patient records that they checked. In a further inspection of 9%, (286) of records, no evidence could be found to say that patients received the information in an accessible format.
Consent to treatment
The CQC state that they have concerns about whether the patient consents, refuses consent or is incapable of consent. They expect to see capacity assessments to support views and possibly evidence that staff have considered ways in which they could help the patient gain or regain capacity. They have frequently raised concerns over whether clinicians have recorded evidence of their conversations with patients who are detained over their proposed treatment and their views. Read More
Learning the lessons from patient safety errors of the past
By John Tingle
A common theme found in patient safety reports in England going back as far as the year 2000 is that the NHS (National Health Service) is poor at learning lessons from previous adverse health incident reports and of changing practice. The seminal report on patient safety in England, Organisation with a memory in 2000 stated:
“There is no single focal point for NHS information on adverse events, and at present it is spread across nearly 1,000 different organisations. The NHS record in implementing the recommendations that emerge from these various systems is patchy. Too often lessons are identified but true ‘active’ learning does not take place because the necessary changes are not properly embedded in practice.” (x-xi).
In late 2003 our NRLS (National Reporting and Learning System) was established.This is our central database of patient safety incident reporting. Can we say today that the NHS is actively learning from the adverse patient safety incidents of the past and changing practice? That the NRLS has been a great success? Or is the jury still out on these questions? Unfortunately the jury is still out. Sadly, there is no shortage of contemporary reports saying that the NHS still needs to improve its lesson learning capacity from adverse events.