Presidential Commission Report on Genomic Privacy

The Presidential Commission for the Study of Bioethical Issues has released its report, "Privacy and Progress in Whole Genome Sequencing." The full text of the report, along with the accompanying press release, is available here. A Google-roundup of news coverage of the release is here.

I looked through the report last night, and am left with the general view that it's a necessary and useful prod to action. The report points out huge gaps in our legal preparedness for the $1000 genome. For example, federal law prohibits health insurers and employers from discriminating against insureds on the basis of genetic information, but life insurers and long-term care insurers aren't covered. Another: only about half of the states have laws in place prohibiting genetic sequencing of persons without their consent.

The report calls for states to adopt "robust" consent standards, though it is skeptical about the workability of rigorous re-consenting of subjects for new research done on their previously-obtained genetic information. It calls for uniform rules governing access to genetic data, and for policies requiring researchers to make clear to subjects whether and in what circumstances incidental findings will be disclosed to them. And it calls for strong standards not only of privacy-protection, but of data-security protection.

It's hard to blame the Commission for remaining at a fairly high level of generality in their recommendations. They were looking at genetic screening by public and private bodies, of persons and of tissue samples, for clinical and research purposes. When you have to talk about everything, it's hard to say much of anything. On the whole, the Commission is to be applauded for bringing policy-makers' attention to, and offering sensible discussions and analysis of, problems associated with genome sequencing for which we are legally unprepared.

More when I've had more time for reading!

Patient Access to Medical Information

A group of health-related federal agencies have proposed a new regulation which would permit clinical laboratories to release test-results to patients who request them. (Currently 39 states either have no state law explicitly permitting such release to patients, or have laws mandating release only to physicians or other healthcare providers.) The current JAMA has a thoughtful analysis of some the questions raised by the new rule. The regulation is supposed to decrease physician workload, reduce the number of patients who never receive test results, and improve follow-up rates. But there are a lot of questions: will patients understand their test-results? will they experience needless anxiety over results that are abnormal but inconsequential? is it useful for patients to receive test results on their own, without medical interpretation or counseling?

Meantime, in the UK, Her Majesty's Treasury has announced in its Autumn Statement (p. 40) that all NHS patients will have online access to their own medical records by the end of this parliament (that is, by 2015). This raises a lot of questions about security and privacy, of course; but also about whether patients may be pressured into supplying their records to third parties.

NHS to Share Patient Data With Industry?

Prime Minister David Cameron will give a speech today in which he'll announce plans for NHS to share its wealth of patient data with private industry, in order to boost the health sciences industry and speed up drug development. The government has assured critics that patient data will be properly anonymized, but there are already protests to the effect that privacy protections won't be adequate, firms will be able to re-identify private health information, and so on. In the same speech, Cameron will announce increased support for and use of tele-medical patient monitoring, and a program to give cancer patients and other seriously-ill patients early access to as-yet-unlicensed drugs.