News in brief from around the world… The past week has seen three US hospitals and one physician penalised for violating the privacy protections of the US Health Insurance Portability and Accountability Act. There have also been further efforts to bring down drug costs in the US senate and the development of a closer relationship between the country’s regulatory agency and its Portuguese counterparts

Regulatory

⇒ Three Boston hospitals have been fined almost US$1 million for compromising patients’ privacy during the filming of a documentary.

The Department of Health and Human Services (HHS) announced on 20 September 2018 that it has reached settlements with Boston Medical Centre, Brigham and Women’s Hospital and Massachusetts General Hospital. Each of the institutions invited film crews onto their premises to film ABC’s TV series “Boston Med”, without patient consent. 

Collectively, the hospitals have paid US$999,000 for violating the Health Insurance Portability and Accountability Act (HIPAA), which is dedicated to protecting patient health information.

HHS guidance also specifies the regulations surrounding filming in hospitals.

“Patients in hospitals expect to encounter doctors and nurses when getting treatment, not film crews recording them at their most private and vulnerable moments,” said Roger Severino, director of the HHS Office for Civil Rights.

“Hospitals must get authorisation from patients before allowing strangers to have access to patients and their medical information,” he added.

⇒ In further HIPAA news, a Massachusetts gynaecologist has been sentenced to one year of probation for allowing a pharmaceutical sales representative access to patient files.

Rita Luthra was also convicted of lying to federal agents, after providing the Warner Chilcott representative with patient information.

This comes at a time when certain regulatory experts are allegedly questioning the effectiveness and enforcement of the HIPAA.

The Act states that the HHS must regulate patient confidentiality, which is known as the HIPAA Privacy Rule. It protects all “individually identifiable health information” held or transmitted by a healthcare organisation in any form of media.

The type of information protected includes an individual’s past, present or future physical or mental health or condition; the provision of healthcare to the individual; and payment for any past, present or future healthcare. The information must also identify or lead to the identification of the individual, in order to qualify under the rule.

Allison Shuren, co-chair of the life sciences and healthcare practice at Arnold & Porter, told PLN that while the HIPAA “probably isn’t perfect”, it is still “good for many situations” and “does a tremendous job of bringing privacy issues to the forefront.”

“When the law was first introduced, it was very complicated, and different agencies often have to try to meet the needs of lots of different people,” she said. “It can often fall on them as to whether they know or have to guess the answer to a particular case.”

⇒ The European Medicines Agency (EMA) has announced that Portugal has been included in the EU-US mutual recognition agreement (MRA) for medicine inspections.

The MRA means that the US and participating EU member states will recognise the inspections of human medicine manufacturing sites in each other’s territories.

The EMA stated on 20 September 2018 that the FDA had confirmed Portugal had the capability to carry out “good manufacturing practice inspections at a level equivalent to the US.”

The MRA covers products such as human chemical pharmaceuticals, medicinal gases and active pharmaceutical ingredients.

Portugal’s inclusion brings the number of participating EU countries up to 15.

The EU has MRAs with several countries, including Australia, Canada and Israel. The EU-US MRA is due to come into effect in July 2019.

⇒ A bipartisan group of US senators has announced a draft bill to tackle surprise medical costs.

The Protecting Patients from Surprise Medical Bills Act (SMBA) would prevent patients from being charged additional emergency healthcare costs when the provider is outside of their insurance network.

Instead of the patient, the insurer would pay any costs which are additional to the amount usually allowed under the insurance plan.

The bill is a response to situations where patients have received unexpected and extortionate additional costs after treatment.

Louisiana senator Bill Cassidy, one of the bill’s sponsors, said “Our proposal protects patients in those emergency situations where current law does not, so that they don’t receive a surprise bill that is basically uncapped by anything but a sense of shame.” 

The SMBA is part of a string of recent bills designed to reduce medical costs for US patients.

Another draft bill, also introduced by Senator Cassidy, intends to lower administrative costs and burdens in healthcare. Additionally, the Senate voted earlier this month to do away with “gag clauses” preventing pharmacies from telling patients how to obtain cheaper drugs.

Courts and cases

⇒ Dublin-based pharmaceutical company Endo Pharmaceutical has announced that it will freeze a lawsuit it had waged against the US Food and Drug Administration (FDA) until the end of the year.

This is to allow the FDA to complete its rulemaking process on regulations surrounding vasopressin, a hormone used in Endo’s “Vasostrict” drug.

Endo’s lawsuit, filed in the District Court for the District of Columbia last year, accused the FDA of unlawfully authorising the bulk compounding of hundreds of drugs through an interim policy, which included the authorisation of a similar rival drug to Vasostrict, produced by Athenex.

The FDA subsequently published a proposal that would exclude three substances from a list of ingredients permitted to be used for bulk compounded medications, including vasopressin.

Endo agreed to stay its lawsuit until 31 December 2018 while the FDA finalised its proposal. If it is finalised, the bulk compounding of vasopressin will be illegal and subject to FDA enforcement.

“We believe that a brief additional stay of our litigation is appropriate to allow FDA to complete its rulemaking process,” said Matthew Maletta, Executive Vice President and Chief Legal Officer of Endo.