The FDA’s NEST Initiative and Women’s Health

The history of medical device regulation in the United States has been shaped by the prominent failure of individual devices, many of which were indicated for women.

The Dalkon Shield intrauterine device infamously ushered in the 1976 amendments to the Federal Food, Drug, and Cosmetics Act, establishing the first pre-market notification and approval process for medical devices in the United States. Similarly, a series of failures among devices designed for women’s health—including the power morcellator, the Essure System, and pelvic mesh—has recently invigorated the FDA’s focus on its post-market regime. Read More

Laboratory IVF petri dish under a microscope.

Fertility Fraud: Major Developments in Texas, Idaho, and Indiana

By Jody Lyneé Madeira

Spring of 2019 brought flowers, showers…and many updates on the “fertility fraud” front.

Perhaps the biggest developments are on the legislative front. On May 5, Indiana Governor Eric Holcomb signed Senate Bill 174 into law, creating civil and criminal causes of action for fertility fraud for former patients and their offspring (and donors whose gametes were used in an unconsented-to manner).

Plaintiffs who sue in tort can be reimbursed for the costs of the fertility procedure and $10,000 in damages. The act makes it a level 6 felony to make a misrepresentation involving human reproductive material and a medical procedure, medical device, or drug. Read More

Are Wellness-Based Insurance Products Really a Win For Everyone?

By Anya Prince 

Insurers have long been in the business of selling a variety of life insurance products to their customers, but a new trend has them promoting wellness and encouraging customers to make healthy lifestyle choices through benefits programs. John Hancock’s Vitality program, for example, offers customers a free Fitbit, savings on annual life insurance premiums, and other discounts and perks for meeting fitness goals.

Other insurers are joining in this wellness game, offering their own versions of incentives and access to wearables in exchange for fitness goals. At first blush, these programs are a classic win-win situation similar to that behind workplace wellness programs. Customers/employees get free wearables. Win! Customers/employees (ideally) live longer due to healthy lifestyle choices. Win! Life insurers/employers have customers that pay premiums for more years before they die and a claim is paid out. Win!  Read More

A yellow dentist chair, in an empty dental office.

Barriers to Dental Care Abound for Individuals with Developmental Disabilities

In early May, a New York Times article profiled the N.Y.U. College of Dentistry’s Oral Health Center for People with Disabilities. As the Times article describes, the new facility establishes an important point of service for people with developmental disabilities in New York City. It also creates a much-needed pipeline for dentists skilled in treating this special population. Read More

Consumer Genetics: To Test or Not to Test?

By Marnie Gelbart and Nadine Vincenten

Direct-to-consumer (DTC) genetic testing has entered our world with a big splash and opened the flood gates of genetic information. For over a decade, we have been out talking with people from all walks of life and listening to their storiesWhether we are speaking with scientists or non-scientists, whear excitement, concerns, ambivalence  – sometimes all three at the same time  and not surprisingly, many many questions as people try to make sense of it all.   

Susan Domchek, executive director of the Basser Center for BRCA, recalls counseling a patient with a family history of breast, ovarian, and colon cancer. This patient had taken a DTC genetic test that looked at her BRCA genes, and the results led her to conclude that she was not at risk for the cancers that had burdened her family. However, the patient did not realize that the test only looked at 3 of the over 1,000 BRCA variants linked to an increased cancer risk. And because the test did not look at other genes implicated in cancer, the physician recognized that it may have underestimated her patient’s risk. What if the patient had seen a doctor who did not understand the limitations of the test? Might she have avoided taking potentially life-saving precautions?  Read More

Privacy as a concept: shadowy opaque faces overlaid with 1s and 0s

Remembering the Real Stakeholders: Patient Privacy Rights Comments on the Proposed CMS Regulation Pursuant to the Cures Act

By Adrian Gropper and Deborah C. Peel

Electronic health records (EHRs) are a polarizing issue in health reform. In their current form, they are frustrating to many physicians and have failed to support cost improvements. The current round of federal intervention is proposed rulemaking pursuant to the 21st Century Cures Act calls for penalties for “information blocking” and for technology that physicians and patients could use “without special effort.”

The proposed rules are over one thousand pages of technical jargon that aims to govern how one machine communicates with another when the content of the communication is personal and very valuable information about an individual. Healthcare is a challenging and unique industry when it comes to interoperability. Hospitals spend lavishly on EHRs and pursue information blocking as a means to manipulate the physicians and patients who might otherwise bypass the hospital on the way to health reform. The result is a broken market where physicians and patients directly control trillions of dollars in spending but have virtually zero market power over the technology that hospitals and payers operate as information brokers. Read More

Robot and human facing each other. silhouetted against lit background

Please and Thank You: Do we Have Moral Obligations Towards Emotionally Intelligent Machines?

By Sonia Sethi

Do you say “thank you” to Alexa (or your preferred AI assistant)?

A rapid polling among my social media revealed that out of 76 participants, 51 percent thank their artificial intelligence (AI) assistant some or every time. When asked why/why not people express thanks, a myriad of interesting—albeit, entertaining—responses were received. There were common themes: saying thanks because it’s polite or it’s a habit, not saying thanks because “it’s just a database and not a human,” and the ever-present paranoia of a robot apocalypse.

But do you owe Alexa your politeness? Do you owe any moral consideration whatsoever? Read More

Why You Must Stop Using the Word, “Privacy” Now

In a recent New York Times Op-Ed, essayist Charlie Warzer suggests that the problem of privacy in modern life is that it’s too complex.

His diagnosis? “Privacy is Too Big to Understand.” While his piece contains important points, he’s wrong. While it is true that the many ways that our data is shared (and how) boggles the mind, the issue is not that privacy is “complex.”

The problem is the term itself. I believe we should stop using the term, “privacy.”   Read More

New Podcast Tackles Drug Pricing, Market Power, and More

About 24 percent of adults report difficulty in affording prescription drugs, including 9 percent who report it is “very difficult” to afford them and 15 percent who report it is “somewhat difficult.” Approximately 11 percent of adults reported rationing high-priced drugs in 2017.

Recently, @Arnold_Ventures launched a new podcast, “Deep Dive with Laura Arnold,” that tackles the issue of drug prices. In its debut episode, podcast host Laura Arnold sits down with David Mitchell, founder of Patients for Affordable Drugs, who began his fight for drug pricing reform after a devastating diagnosis of an incurable blood cancer. The cost of his medicine each year: $325,000. They discuss a broken system built to serve those who make money — not those who depend on it for their health.

“Our mission is to improve people’s lives by fixing broken systems,” Arnold says. “We view drug pricing as a broken system, and not just from a theoretical perspective, but from a human perspective. We see this as a crisis in our nation. People can’t afford their drugs, and the consequences for all of us, both personally and from a societal perspective, are dire.”

Read More

A group of surgeons perform an operation in a hospital operating theatre.

Keeping up to Date with Global Patient Safety

One of the great difficulties in patient safety and health quality is keeping up to date with all the material that is produced. A myriad number of patient safety and health resources exist globally. By sharing good quality resources, we can help advance the global patient safety agenda.

NHS Resolution (the operating name of the National Health Service Litigation Authority) has excellent patient safety and clinical negligence resources, learning materials and should be viewed as a priority global information source.

NHS Resolution is a Special Health Authority and is a not-for-profit arm’s length body of the Department of Health and Social Care.It is a part of the NHS and has several functions including handling negligence claims on behalf of NHS organizations and independent sector providers of NHS care in England who are members of the NHS Resolution indemnity schemes. Read More