FDA  Poster “Service Level Agreements for 5G and Beyond: Overview, Challenges and Enablers of 5G-Healthcare Systems” by Naeem Qureshi, Haneya, Manalastas, Marvin, Zaidi, Syed Muhammad Asad,  Imran, Ali,  Al Kalaa, Mohamad Omar

LINK to the FDA Graphic “Service Level Agreements for 5G and Beyond: Overview, Challenges and Enablers of 5G-Healthcare Systems”

Note: This is also in the IEEE at this link. 

“Documenting assurances of 5G network performance can be in the form of a service level agreement (SLA), which is a commitment between two or more parties that documents the details of various aspects of services that one party will provide to the other. This is relevant for 5G-enabled medical devices where the patient safety and medical device effectiveness depend on the 5G services provided by network operators. There are gaps in the literature regarding 5G SLAs and SLAs of 5G-enabled healthcare. Therefore, we give in this paper a brief overview of SLAs and highlight the challenges, requirements and outlook for SLAs in 5G and beyond environments and expand on SLA considerations specific to 5G-enabled medical devices.”

H. N. Qureshi, M. Manalastas, S. M. A. Zaidi, A. Imran and M. O. Al Kalaa, “Service Level Agreements for 5G and Beyond: Overview, Challenges and Enablers of 5G-Healthcare Systems,” in IEEE Access, vol. 9, pp. 1044-1061, 2021, doi: 10.1109/ACCESS.2020.3046927.

“Why is the FDA investigating “cybersecurity threats to the 5G ecosystem but not health threats? ” asks Theodora Scarato Executive Director of Environmental Health Trust after reviewing the FDA  graphic on 5G.

Scarato pointed out that there is even a working group focused on 5G-enabled healthcare technologies. Press reports state that “The goal of this group, championed by FDA, is to bring key stakeholders and ideas from different sectors to improve the process for development and assessment of novel medical devices enabled by 5G wireless communication, while ensuring patient safety.”

“Topics and activities envisioned by this working group include:

• Identifying medical device 5G use-cases and best practices for 5G integration
• Outlining evaluation methods for the safe and effective use of 5G in medical devices
• Incorporating telecommunication technology suppliers in the medical device supply chain
• Managing the relationship between the device manufacturer, network operator, and the end user throughout the pre-market and post-market cycle”

Read more about the new 5G working group at https://mdic.org/news/mdic-launches-new-5g-working-group/ 

Myth: The Food And Drug Administration (FDA) has reviewed the science on 5G and cell towers and determined the radiation is safe and FCC limits protect public health. 

Myth: The FDA’s website clearly shows that the FDA has reviewed the totality of scientific evidence and found cell phones, 5G and cell towers are safe. After all, the FDA concluded in February of 2020 that “there is no consistent or credible scientific evidence of health problems caused by the exposure to radio frequency energy emitted by cell phones.” 

Fact: The FDA has never evaluated the totality of the science to conclude any opinion on the safety of human exposure to 5G technology or cell tower radiation.  All the FDA has done is release a now outdated literature review, concluding in 2018, focused solely only on cell phones and cancer. This literature review omits studies on damage to DNA, the brain and reproduction. The FDA literature review is not a systematic review, nor is it a risk analysis, nor is it an evaluation of FCC cell tower radiation limits, despite being presented in this way. 

Fact: The FDA has no authority in regards to cell tower radiation and 5G infrastructure. This was confirmed in a January 11, 2022 letter by Ellen Flannery of the Director of the FDA Office of Policy Center for Devices and Radiological Health, who wrote that the FDA doesn’t regulate cell towers. When asked about the safety of a cell tower outside a California mother’s window, she responded,  “The FDA does not regulate cell towers or cell tower radiation.  Therefore, the FDA has no studies or information on cell towers to provide in response to your questions.” Link to FDA Letter. 

Environmental Health Trust is a leading think tank on wireless radiation and we are busting misinformation. While the public might assume the FDA is always monitoring the science and monitoring exposures, this is inaccurate. For example, the 2021 FDA’s  Annual report was released on January 31, 2022, and there is no mention of the issue of cell phones or cell towers or wireless electromagnetic radiation. The FDA has not shown any evidence of monitoring research with new agency reports, meetings or budget on the issue. 

As the Pittsburgh Law Review article concludes, “The FCC and FDA have failed in their obligation to prescribe safe RFR guidelines produced from wireless communication devices to protect the public’s health and safety.” 

 

Additional Documentation by the Environmental Health Trust 

• The Government Accountability Report on 5G (GAO 2020) clarified that the FDA and other organizations “only reviewed a subset of the relevant research”  and stated in regards to the FDA Literature Review that “The assessment focused on cancer-related animal and human studies of frequencies below 6 GHz.” 
• Not only did the FDA do a limited literature review looking only at cancer, but it omitted impacts to the brain, oxidative stress, and reproduction. It omitted evaluation of children’s unique vulnerability. Most importantly it discounted the results of the National Toxicology Program, which is why numerous scientists —- including several now retired US government scientists —-  are calling for the FDA to retract the review, as it offers unsubstantiated assurance of safety (EHT 2020).  
• EHT’s 150 page report “FDA’s Misleading Information on Cell Phone Radiation on the FDA documents the lack of adequate research review and misleading information put forward by the FDA. 
• In 2020, the FDA refused to testify to the New Hampshire State Commission on 5G and refused to answer specific questions regarding it’s purported review of health effects of 5G and wireless networks.  Although the FDA responded with a few general sentences about how “FDA’s doctors, scientists and engineers continually monitor the scientific studies and public health data for evidence that radio frequency energy from cell phones could cause adverse health effects, “the FDA refused to answer specifics such as providing reports or answering questions about the safety margin, and the FDA’s research activities. Read FDA Communications with the New Hampshire 5G Commission  

EHT’s 150 page report “FDA’s Misleading Information on Cell Phone Radiation documents the lack of adequate research review and misleading information put forward by the FDA.