Home is where you hang your medical test

The rise of at-home medical testing appears to be a positive step into the future. However, a closer look reveals there are significant medical and legal risks to which which manufacturers (and their Insurers) should be alert

Let me introduce you to Ms Smith; a busy woman who works long hours, values her privacy, and occasionally gets anxious. Ms Smith thinks she may be pregnant, and so goes to the pharmacist for a pregnancy test. This pregnancy test is the perfect tool for Ms Smith's needs. Why should busy Ms Smith have to take time out of her hectic schedule to book a doctor's appointment and wait for the date to come around, when she could get an answer straight after a quick shopping trip?

Home pregnancy tests have become widely accepted since they first became available in the 1970s. However, initially they were not universally welcomed; in 1974 the consumer organisation Which? advised against home testing, warning that "users would be wasting their money". But the technology is now so commonplace that Ikea recently used it to create an advert which doubled as a pregnancy test, revealing a voucher for cribs if the test was positive.

The benefits of at-home testing are clear: convenience, fast results and privacy. Let's say, some years later, Ms Smith is concerned that she might have bowel cancer. She can now test for that at home too. This test is easily available from pharmacists alongside a variety of other tests, (such as for diabetes or cholesterol). These have not yet gained the widespread acceptance of pregnancy tests. The home test for bowel cancer has been criticised for being less accurate than NHS screening tests, with inadequate instructions.

And, at-home testing comes with significant risks. What if Ms Smith reviews the result of her bowel cancer test and (wrongly) concludes she has cancer? Who will be held accountable for her resulting stress until a doctor makes the correct diagnosis? Who will pay for the additional (possibly unwarranted) testing in order to confirm the correct diagnosis? Questions need to be asked as to where the fault would lie if the mistake came about because Ms Smith performed the test incorrectly or misinterpreted the results; is that her fault or the fault of the manufacturers who failed to give clear instructions?

The more significant risk manufacturers (and their Insurers) need to consider is the fallout from a "false negative" result. In this instance, manufacturers could be faced with a claim for delay in diagnosis and treatment, which can stretch to hundreds of thousands of pounds.

Manufacturers or suppliers of these at-home medical tests (and their Insurers) could be faced with claims under the Consumer Protection Act if mistakes occur. In order to avoid such claims (and provide a robust defence in the event claims are brought) they should ensure the products are dispensed alongside comprehensive instructions and a detailed risk assessment.

For Insurers, the primary concern will be (quickly!) identifying where liability lies. Insurers need to ensure that manufacturers are collecting and reviewing data about the product regularly, to identify if there are any defects (as opposed to user error) or whether product information needs to be updated so that, if necessary, changes can be made or appropriate recall processes can be initiated to limit damage.

Some at-home tests are regulated by the MHRA (Medicines and Healthcare products Regulatory Agency). Manufacturers should therefore start to consider whether they are complying with the forthcoming Medical Devices Regulations, which have an implementation date of 2022.

As with pregnancy tests, other at-home tests are likely to become widely accepted in the future enabling consumers to obtain fast results with convenience and in the privacy of their own home. If so, the market must heed the risks and adjust accordingly.