The U.S. FDA has issued draft guidance on electromagnetic compatibility (EMC) of medical devices. It aims to provide information that should be provided in a premarket submission to demonstrate EMC for electrically powered medical devices and medical devices with electrical or electronic functions. This draft guidance is not intended to change current policy; instead, it aims to give additional technical information to address the recommendations in the 2016 EMC guidance document. This draft guidance, when final, will replace the old document titled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices.” Interested parties may submit comments through Jan. 19, 2021.
Vaccine, diagnostic developers targeted by cyberattacks
All those rumors about international cyberattacks against U.S. companies engaged in COVID-19 research are more than just rumors or hyped-up accusations driven by a heated presidential campaign. “In recent months, we’ve detected cyberattacks from three nation-state actors targeting seven prominent companies directly involved in researching vaccines and treatments for COVID-19,” Tom Burt, corporate vice president for customer security and trust at Microsoft, wrote in a Nov. 13 company blog. The targets included leading biopharma companies and vaccine researchers in Canada, France, India, South Korea and the U.S., Burt said, and the attacks came from Russia-based Strontium and two North Korea actors, Zinc and Cerium. Most of the targets have been companies with COVID-19 vaccines in various stages of clinical trials. However, one target was a clinical research organization involved in the trials, and another had developed a COVID-19 test. Several of the targeted firms have COVID-19 contracts with or investments from various government agencies. As for the attacks themselves, Strontium uses what Burt called password spray and brute force login attempts to steal login credentials. Zinc primarily uses spear-phishing lures to steal credentials, sending messages with fabricated job descriptions from fake recruiters. Cerium also uses spear-phishing email tactics, using COVID-19 lures and pretending to be World Health Organization representatives. Most of the attacks were blocked by built-in security protections, but some have been successful. Earlier in the pandemic, hospitals, clinics and health care systems and agencies across the globe were targeted by cyberattacks, and one woman reportedly died at a hospital in Germany when it suffered a ransomware attack. “We think these attacks are unconscionable and should be condemned by all civilized society. Today, we’re sharing more about the attacks we’ve seen most recently and are urging governments to act,” Burt said, in explaining the purpose of the blog post. It’s not enough to enforce the law against such attacks only when they originate from government agencies, he said, noting that governments must be held responsible for enabling or facilitating cybercriminal groups to operate within their borders, as well. “This is criminal activity that cannot be tolerated,” Burt added.
Groups make case for extending sequester moratorium
Recognizing that “it will be at least several months before life begins to return to ‘normal,’” several U.S. health care organizations are asking Congress to extend the current moratorium on the Medicare sequestration cuts until the end of the COVID-19 public health emergency. The temporary moratorium, put in place in May by the CARES Act, is set to expire Jan. 1, 2021. Conceived as a national debt control effort, the 2% Medicare sequestration has been in force since 2012, reducing reimbursement for physician-administered Part B drugs, as well as for other Medicare-covered services. “Emerging trends in both infection and hospitalization rates signal that the worst is not yet behind us. … These infection rates signal renewed stress on our health care system as we enter the winter months with the virus more likely to spread from indoor transmissions,” the health care organizations said in a letter last week to House and Senate leaders. “This upsurge in cases also has impacted the financial health of medical professionals and facilities, including the increased cost of labor to ensure adequate staffing, procurement of personal protective equipment (PPE), significant reductions in patient volume resulting from orders to cancel nonemergent procedures, and the high cost of caring for COVID patients,” the groups said.
More money needed for global vaccine effort
Gavi, an international vaccine alliance, reported Nov. 13 that it has raised more than $2 billion in pledges for its COVID-19 Vaccines Advance Market Commitment. The funding raised to date will be used to reserve 1 billion vaccine doses for distribution in qualifying low- and middle-income countries. The funding has been pledged by wealthier countries, the private sector and philanthropies. As the pandemic continues, Gavi said at least $5 billion will be needed in 2021 to ensure equitable vaccine distribution. “This vital funding not only helps us ensure lower-income economies aren’t left at the back of the queue when safe and effective COVID-19 vaccines become available, it will also play a vital role in ending the acute phase of this pandemic worldwide,” Gavi CEO Seth Berkley said.
Russia extends COVID-19 drug, device program
The Russian government is extending, by one year, the simplified registration procedure for drugs and medical devices used in treating COVD-19. The procedure, which accelerates the registration of the devices and the obtaining of drug permits, was to expire Jan. 1, 2021, but it’s now being extended until Jan. 1, 2022, according to the Russian Ministry of Health. The extension is expected to help avoid shortages of the drugs and devices needed to treat patients with COVID-19.