HIPAA is the Tip of the Iceberg When it Comes to Privacy and Your Medical Data

Big data continues to reshape health. For patient privacy, however, the exponential increase in the amount of data related to patient health raises major ethical and legal challenges.

In a new paper in Nature Medicine, “Privacy in the age of medical big data,” legal and bioethical experts W. Nicholson Price and I. Glenn Cohen examine the ways in which big data challenges the protection (and the way we conceive) of health care privacy. Read More

close up of human eye

The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More

Machine Learning in Medicine: Addressing Ethical Challenges

Machine learning in medicine is accelerating at an incredible rate, bringing a new era of ethical and regulatory challenges to the clinic.

In a new paper published in PLOS Medicine, Effy Vayena, Alessandro Blasimme, and I. Glenn Cohen spell out these ethical challenges and offer suggestions for how Institutional Review Boards (IRBs), medical practitioners, and developers can ethically deploy machine learning in medicine (MLm). Read More

Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Data-driven Medicine Needs a New Profession: Health Information Counseling

By Barbara Prainsack, Alena Buyx, and Amelia Fiske

Have you ever clicked ‘I agree’ to share information about yourself on a health app on your smartphone? Wondered if the results of new therapy reported on a patient community website were accurate? Considered altering a medical device to better meet your own needs, but had doubts about how the changes might affect its function?

While these kinds of decisions are increasingly routine, there is no clear path for getting information on health-related devices, advice on what data to collect, how to evaluate medical information found online, or concerns one might have around data sharing on patient platforms.

It’s not only patients who are facing these questions in the age of big data in medicine. Clinicians are also increasingly confronted with diverse forms of molecular, genetic, lifestyle, and digital data, and often the quality, meaning, and actionability of this data is unclear.

The difficulties of interpreting unstructured data, such as symptom logs recorded on personal devices, add another layer of complexity for clinicians trying to decide which course of action would best meet their duty of beneficence and enable the best possible care for patients.

Read More

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

The EU’s GDPR in the Health Care Context 

By Sara Gerke 

The EU’s General Data Protection Regulation, which came into force two years ago but became directly applicable in all EU Member States only last week, aims to establish an equal level of protection for the rights and freedoms of natural persons with regard to the processing of personal data in all EU Member States.

Each of us has been inundated with emails in the last few days and weeks, informing us about the GDPR and asking us, among other things, to review updated privacy policy. This flood of emails is, in particular, the consequence of the GDPR’s imposing administrative fines for infringements.

According to its territorial scope, the GDPR can also impact US companies that process personal data of data subjects who are in the EU. For example, this is the case for newspapers and affiliated websites, where the processing activities are related to the offering of services or goods, irrespective of whether payment is required. Some papers decided to simply block users in the EU, rather than abide by the GDPR’s provisions. 

Read More

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Read More

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Read More

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Read More